Stress Urinary IncontinenceNCT07905586
Feasibility of Resisted Expiratory Muscle Training for Females Assigned at Birth With Stress Urinary Incontinence: A Pilot Study
A study testing Pelvic floor muscle training and Expiratory muscle strength training in people with Stress Urinary Incontinence, run by Thomas Jefferson University.
Trial summary
The goal of this randomized pilot study is to determine whether adding expiratory muscle strength training (EMST) to standard pelvic floor muscle training (PFMT) is feasible and may help improve stress urinary incontinence (SUI) in females assigned at birth, ages 18 to 79. Read more about this study
- Who is it for?
- Ages 18 to 79 years, women only
- Conditions the study is for
- Stress Urinary Incontinence
- What is being tested?
- Pelvic floor muscle training and Expiratory muscle strength training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2027to 30 Jun 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 79 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female assigned at birth, 18-79 years of age
- Self-reported stress urinary incontinence for greater than 3 months
- International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF) score >6
- Able to understand the study procedures and provide informed consent
- English language proficiency
Who cannot join
- Males assigned at birth
- Individuals <18 or >80 years old
- Current pregnancy or planning to become pregnant during the study period
- Pelvic, abdominal, esophageal, or head/neck surgery within the previous 6 months
- Healing rib fractures
- Neurologic conditions
Show all 11Show fewer
- Active urinary tract infection
- Current participation in supervised pelvic floor muscle training outside of the study
- Inability to safely perform maximal expiratory efforts
- Contraindications to expiratory muscle strength training (EMST), including presence of untreated or uncontrolled hypertension, unstable heart conditions, history of spontaneous pneumothorax, active hemoptysis, history of ruptured eardrum or active ear conditions, history of high intraocular pressure including glaucoma and retinal disease, elevated intracranial pressure, severe chronic obstructive pulmonary disease, or healing rib fractures
- History of lung surgery
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Feasibility of Resisted Expiratory Muscle Training for Females Assigned at Birth With Stress Urinary Incontinence: a Pilot Study
The goal of this randomized pilot study is to determine whether adding expiratory muscle strength training (EMST) to standard pelvic floor muscle training (PFMT) is feasible and may help improve stress urinary incontinence (SUI) in females assigned at birth, ages 18 to 79. SUI is urine leakage that occurs during activities such as coughing, sneezing, laughing, or exercising.
The main questions this study aims to answer are:
Read more
Can participants complete the combined exercise program, and is it acceptable to them?
Does adding EMST to PFMT lead to greater improvements in urinary leakage symptoms and participants' perceived improvement compared with PFMT alone?
Does adding EMST improve breathing muscle strength and pelvic floor muscle activity?
Researchers will enroll 24 participants and randomly assign them to one of two groups:
Group 1: Standard physical therapy, including pelvic floor muscle training.
Group 2: The same physical therapy and pelvic floor muscle training, with the addition of expiratory muscle strength training.
Both groups will receive six weeks of supervised physical therapy, with one session each week. Participants will attend seven study visits over approximately seven weeks, including an initial assessment and six treatment visits.
Participants will:
Complete questionnaires about urinary leakage symptoms and perceived improvement.
Have their breathing muscle strength measured using a test that measures how strongly they can breathe out.
Have pelvic floor muscle activity measured using a surface electromyography (sEMG) sensor.
Perform prescribed home exercises and record their exercise completion in a log.
Participants in both groups will practice pelvic floor muscle exercises at home. Participants in the combined-treatment group will also use a device that provides resistance when breathing out. They will perform five sets of five breaths daily, with resistance based on their measured breathing muscle strength.
Researchers will assess whether participants complete the study visits, follow the home exercise program, complete the study measures, and report satisfaction with the program. They will also monitor any unwanted effects related to the exercises or assessments.
The study will explore whether adding EMST to PFMT may improve urinary leakage symptoms, breathing muscle strength, and pelvic floor muscle activity. Participants may experience improvements, but benefits are not guaranteed. The results will help researchers determine whether a larger study is needed to better evaluate this combined treatment for stress urinary incontinence.
Read the detailed description
Stress urinary incontinence (SUI) is the involuntary leakage of urine during activities that increase pressure within the abdomen, such as coughing, sneezing, laughing, or exercising. Pelvic floor muscle training (PFMT) is a recommended conservative treatment for SUI. However, treatment outcomes vary, and some individuals have difficulty identifying and correctly contracting their pelvic floor muscles.
The pelvic floor muscles work in coordination with the diaphragm, abdominal wall, and respiratory muscles to regulate pressure within the abdomen. Research has demonstrated coordinated pelvic floor muscle activity during forced expiration, coughing, and other tasks that increase abdominal pressure. Maximal expiratory pressure (MEP), a measure of expiratory muscle strength, has also been associated with SUI severity. These findings suggest that respiratory muscle function may be relevant to urinary continence.
Expiratory muscle strength training (EMST) involves breathing out against resistance using a specialized device. This training may improve expiratory muscle strength and promote coordinated activation of the respiratory and pelvic floor muscles. Although EMST has been studied in other rehabilitation populations, its feasibility and potential effects when combined with PFMT for SUI have not been adequately established.
This pilot randomized controlled study will evaluate the feasibility and acceptability of adding EMST to standard PFMT and estimate preliminary effects on urinary incontinence symptoms, expiratory muscle strength, and pelvic floor muscle activity. The study will also examine relationships between changes in physiological measures and changes in urinary incontinence symptoms. Findings will inform the design of a future, adequately powered randomized controlled trial.
Study Design and Procedures
This study uses a single-site, parallel-group randomized controlled feasibility design. A total of 24 eligible participants will be enrolled and assigned to one of two treatment groups, with 12 participants planned for each group. Participants will complete seven study visits over approximately seven weeks: one baseline assessment followed by six weekly supervised physical therapy sessions.
At the baseline visit, a licensed physical therapist with pelvic health training will conduct a physical therapy evaluation. Participants will complete questionnaires and undergo measurements of expiratory muscle strength and pelvic floor muscle activity. Both groups will receive standardized education about the role of the pelvic floor muscles and bladder in urinary continence.
Participants will complete assessments at baseline (Visit 1), midpoint (Visit 4), and after the intervention (Visit 7). The Global Rating of Change (GROC) questionnaire will be administered at the final visit. Exercise adherence will be monitored using home exercise logs.
Treatment Groups Group 1: Pelvic Floor Muscle Training: Participants will receive standard physical therapy care, including supervised PFMT once weekly for six weeks. A licensed physical therapist with pelvic health training will provide individualized instruction and progress exercises according to the treatment plan.
Participants will complete a home PFMT program consisting initially of five sets of five submaximal repetitions daily. Exercises will progress during the six supervised sessions, with repetitions increasing to as many as 100 per day in gravity-dependent positions, as prescribed by the treating physical therapist.
Group 2: Pelvic Floor Muscle Training Plus Expiratory Muscle Strength Training:
Participants will receive the same supervised physical therapy and PFMT program as Group 1, with the addition of EMST.
EMST will be performed using a calibrated expiratory resistance device. The initial training resistance will be set at 50% of the participant's measured MEP. Participants will perform five sets of five breaths daily as part of their home exercise program. The treating physical therapist will provide instruction on device use and exercise technique. Training intensity will be maintained or progressed according to participant tolerance and the therapist's assessment of safe performance.
Participants in both groups will receive verbal and written instructions for their home exercises and will record exercise completion in a log.
Physiological Assessments:
Maximal Expiratory Pressure: MEP will be measured to characterize expiratory muscle strength and establish the initial resistance for EMST in the combined-treatment group. MEP will be assessed at baseline, midpoint, and after the intervention.
Pelvic Floor Muscle Activity: Pelvic floor muscle activity will be measured using surface electromyography (sEMG) with a vaginal surface sensor. Measurements will be collected during standardized tasks, including quiet breathing, forced expiration, coughing, and maximal voluntary contractions. Assessments will occur at baseline, midpoint, and after the intervention.
The physiological assessments will be used to estimate changes in expiratory muscle strength and pelvic floor muscle activation over the intervention period.
Clinical Assessments:Urinary incontinence symptoms will be assessed using the International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF). This self-report questionnaire will be completed at baseline, midpoint, and after the intervention.
Participants will also complete the GROC at the final visit to describe their perceived change over the course of treatment.
A participant satisfaction questionnaire will be used to assess acceptability. Exercise logs and study records will be used to evaluate adherence, visit completion, and retention.
Feasibility and Safety Monitoring:The primary purpose of this pilot study is to determine whether the combined PFMT and EMST intervention can be implemented as planned and whether participants can complete the study procedures and home exercise program.
Feasibility will be evaluated using recruitment and eligibility information, participant retention, adherence to prescribed home exercises, completion of outcome assessments, and participant satisfaction. Intervention-related adverse events will also be recorded and summarized.
The study team will monitor participants during supervised sessions for symptoms such as pain, dizziness, or excessive fatigue. Exercise intensity will be maintained or reduced if participants cannot complete the prescribed exercises safely and with appropriate technique. Supervised procedures will be stopped if concerning symptoms occur. Participants will be instructed to stop home exercises if they experience significant pain, dizziness, or other unexpected adverse effects and to contact the study team before resuming.
Potential risks include mild muscle soreness or fatigue, temporary dizziness during MEP testing, discomfort during insertion or removal of the vaginal sEMG sensor, and minor irritation, bleeding, or infection associated with sensor placement. Participants may also experience emotional discomfort related to discussing urinary symptoms or undergoing pelvic floor assessment. The study team will use established safety procedures and protect participant confidentiality.
Statistical Analysis
The planned sample of 24 participants, with 12 participants per group, is intended for a pilot feasibility study and preliminary estimation of treatment effects. The study is not designed to establish definitive treatment efficacy.
Feasibility outcomes, including eligibility, retention, adherence, outcome assessment completion, participant satisfaction, and adverse events, will be summarized using appropriate descriptive statistics and 95% confidence intervals.
Linear mixed-effects models will be used to estimate changes in clinical outcomes over time. Models will include treatment group, time, and the group-by-time interaction, with baseline variables included as covariates. Similar models will evaluate changes in MEP and sEMG amplitude.
Participants will also be classified as responders based on a change of 2.52 points on the ICIQ-UI SF, the published minimal clinically important difference specified in the protocol. The proportion of responders in each group will be summarized, and an odds ratio will be calculated to compare responder rates.
Exploratory correlation analyses will examine relationships between physiological and clinical changes. These analyses will assess associations between changes in MEP and ICIQ-UI SF scores, changes in sEMG amplitude and ICIQ-UI SF scores, changes in MEP and GROC scores, and changes in sEMG amplitude and GROC scores. Pearson or Spearman correlation coefficients will be selected according to the distribution of the data.
Linear mixed-effects models will accommodate incomplete repeated outcome measurements under the assumption that data are missing at random.
Expected Contribution
This study will provide preliminary information about the feasibility, acceptability, and potential clinical and physiological effects of adding EMST to standard PFMT for SUI. Results will help estimate treatment effects, variability, adherence, and outcome completion rates to support the planning of a future larger randomized controlled trial. The study may also help clarify whether changes in expiratory muscle strength and pelvic floor muscle activity are associated with changes in urinary incontinence symptoms.
- Conditions
- Stress Urinary Incontinence
- Being tested
- Pelvic floor muscle training, Expiratory muscle strength training
- Keywords
- stress urinary incontinence, pelvic floor muscle training, expiratory muscle strength training, pelvic floor rehabilitation, physical therapy
- Medical subject headings
- Urinary Incontinence, Stress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pelvic floor muscle trainingOther
PFMT: Participants will be instructed in a home exercise program of pelvic floor muscle training (PFMT) at 5 sets of 5 submaximal repetitions daily. Through the 6 intervention sessions, exercise repetitions will increase to up to 100 per day in gravity dependent positions.
Expiratory muscle strength trainingOther
EMST: Participants will use a calibrated expiratory resistance device at 50% of MEP, 5 sets of 5 breaths daily.
| Study group | Role | What they receive |
|---|---|---|
| Pelvic floor muscle training | Active comparator | Pelvic floor muscle training (PFMT): Participants will be instructed in a home exercise program of PFMT at 5 sets of 5 submaximal repetitions daily. Through the 6 intervention sessions, exercise repetitions will increase to up to 100 per day in gravity dependent positions. Receives: Other: Pelvic floor muscle training |
| Pelvic floor muscle training + expiratory training | Experimental | Expiratory Muscle Strength Training (EMST): Participants will use a calibrated expiratory resistance device at 50% of MEP, 5 sets of 5 breaths daily.
PFMT: Participants will be instructed in a home exercise program of PFMT at 5 sets of 5 submaximal repetitions daily. Through the 6 intervention sessions, exercise repetitions will increase to up to 100 per day in gravity dependent positions. Receives: Other: Pelvic floor muscle training; Other: Expiratory muscle strength training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Attrition
Attrition will be assessed as a feasibility outcome to evaluate participant retention throughout the study. Attrition will be defined as the proportion of enrolled participants who discontinue study participation before completing the final study visit (Visit 7). The attrition rate will be calculated by dividing the number of participants who withdraw or discontinue participation before study completion by the total number of participants enrolled, multiplied by 100. The number and percentage of participants who complete the study will also be reported. Reasons for withdrawal or discontinuation will be documented when available. Attrition and retention rates will be summarized descriptively using counts, percentages, and 95% confidence intervals to evaluate the feasibility of participant retention in the study.
Measured: This is a post measure after completion of the 7 week study.
Eligibility rates
Eligibility rate will be assessed as a feasibility outcome to evaluate the proportion of individuals screened who meet the study's eligibility criteria. The eligibility rate will be calculated by dividing the number of individuals determined to be eligible by the total number of individuals screened and multiplying by 100. Eligibility will be determined based on the study's prespecified inclusion and exclusion criteria, including an ICIQ-UI SF score of at least 6. The number and percentage of individuals who are eligible and ineligible will be summarized descriptively. Reasons for ineligibility will be documented when available. The eligibility rate will be reported as a percentage with a 95% confidence interval to evaluate the feasibility of identifying an appropriate study population.
Measured: This is a post measure after completion of the 7 week study.
Secondary outcomes (8)
Global rating of change
The Global Rating of Change (GROC) is a patient-reported measure used to assess participants' perceived overall change in symptoms following the intervention. At the final study visit, participants will rate how their urinary incontinence symptoms have changed compared with their status before beginning the intervention. Responses will be recorded using a 7-point ordinal scale ranging from 1 (very much better) to 7 (very much worse), with a score of 4 indicating no change. Lower scores indicate greater perceived improvement, whereas higher scores indicate greater perceived worsening. The GROC will be administered at Visit 7 and used to characterize participants' overall perceptions of treatment-related change.
Measured: at visit 7 which is 6 weeks after baseline.
Maximum expiratory pressure
Maximal expiratory pressure (MEP) is an objective measure of respiratory muscle strength that assesses the maximum pressure generated during a forceful expiration against an occluded airway. MEP will be measured using a respiratory pressure manometer and expressed in centimeters of water (cm H₂O). Participants will be seated and instructed to inhale maximally, followed by a forceful, sustained exhalation into the manometer mouthpiece. Measurements will be repeated according to a standardized testing protocol, with adequate rest between attempts to minimize fatigue. The highest acceptable and reproducible pressure value will be recorded for analysis. Higher MEP values indicate greater expiratory pressure-generating capacity and are used to characterize respiratory muscle strength at baseline and assess changes following the intervention. MEP will be measured at Visits 1, 4, and 7.
Measured: at visit 4 which is 3 weeks after baseline.
Maximum expiratory pressure
Maximal expiratory pressure (MEP) is an objective measure of respiratory muscle strength that assesses the maximum pressure generated during a forceful expiration against an occluded airway. MEP will be measured using a respiratory pressure manometer and expressed in centimeters of water (cm H₂O). Participants will be seated and instructed to inhale maximally, followed by a forceful, sustained exhalation into the manometer mouthpiece. Measurements will be repeated according to a standardized testing protocol, with adequate rest between attempts to minimize fatigue. The highest acceptable and reproducible pressure value will be recorded for analysis. Higher MEP values indicate greater expiratory pressure-generating capacity and are used to characterize respiratory muscle strength at baseline and assess changes following the intervention. MEP will be measured at Visits 1, 4, and 7.
Measured: at visit 7 which is 6 weeks after baseline
surface EMG
Pelvic floor muscle activity will be assessed using vaginal surface electromyography (sEMG) with an intravaginal sensor to measure the amplitude of electrical activity generated during pelvic floor muscle contractions. A trained, licensed physical therapist with pelvic health training will position the vaginal sensor according to the device manufacturer's instructions. Participants will be instructed to perform a maxiumal and submaximal voluntary pelvic floor muscle contraction, and the sEMG system will record the resulting electrical activity. Amplitude will be expressed in microvolts (µV), with higher values generally indicating greater recorded electrical activity during contraction. Measurements will be obtained using a standardized testing protocol at Visits 1, 4, and 7 to characterize pelvic floor muscle activation and explore changes following the intervention.
Measured: at visit 4 which is 3 weeks after baseline
surface EMG
Pelvic floor muscle activity will be assessed using vaginal surface electromyography (sEMG) with an intravaginal sensor to measure the amplitude of electrical activity generated during pelvic floor muscle contractions. A trained, licensed physical therapist with pelvic health training will position the vaginal sensor according to the device manufacturer's instructions. Participants will be instructed to perform a maxiumal and submaximal voluntary pelvic floor muscle contraction, and the sEMG system will record the resulting electrical activity. Amplitude will be expressed in microvolts (µV), with higher values generally indicating greater recorded electrical activity during contraction. Measurements will be obtained using a standardized testing protocol at Visits 1, 4, and 7 to characterize pelvic floor muscle activation and explore changes following the intervention.
Measured: at visit 7 which is 4 weeks after baseline
International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form
The International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF) is a validated, self-administered questionnaire used to assess the frequency, amount, and impact of urinary incontinence on quality of life. The questionnaire consists of three scored items addressing the frequency of urinary leakage, the amount of urine typically leaked, and the degree to which urinary leakage interferes with everyday life. An additional unscored item asks participants to identify situations in which leakage occurs. Responses are scored on a scale from 0 to 21, with higher scores indicating greater symptom severity and greater impact of urinary incontinence. The total score is calculated by summing the three scored items. The instrument will be completed independently by participants on paper and scored manually.
Measured: Baseline after consent; a score <6 will exclude from inclusion in the study.
International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form
The International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF) is a validated, self-administered questionnaire used to assess the frequency, amount, and impact of urinary incontinence on quality of life. The questionnaire consists of three scored items addressing the frequency of urinary leakage, the amount of urine typically leaked, and the degree to which urinary leakage interferes with everyday life. An additional unscored item asks participants to identify situations in which leakage occurs. Responses are scored on a scale from 0 to 21, with higher scores indicating greater symptom severity and greater impact of urinary incontinence. The total score is calculated by summing the three scored items. The instrument will be completed independently by participants on paper and scored manually.
Measured: at visit 4 which is 3 weeks after baseline.
International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form
The International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF) is a validated, self-administered questionnaire used to assess the frequency, amount, and impact of urinary incontinence on quality of life. The questionnaire consists of three scored items addressing the frequency of urinary leakage, the amount of urine typically leaked, and the degree to which urinary leakage interferes with everyday life. An additional unscored item asks participants to identify situations in which leakage occurs. Responses are scored on a scale from 0 to 21, with higher scores indicating greater symptom severity and greater impact of urinary incontinence. The total score is calculated by summing the three scored items. The instrument will be completed independently by participants on paper and scored manually.
Measured: at visit 7 which is 6 weeks after baseline.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2026
- Study start1 Jan 2027 (estimated)
- Primary completion30 Jun 2028 (estimated)
- Study completion30 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Stress Urinary IncontinenceStudies of the same condition, open and under way.
- More trials run by Thomas Jefferson UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Thomas Jefferson University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07905586
- Sponsor's protocol ID
- Pelvic floor and EMST
- Status last verified
- Oct 2026
- First submitted
- 23 Oct 2026
- Last updated
- 29 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Barbosa-Silva J, Zanello SC, Jorge CH, Driusso P. Do young women have an accurate perception about their pelvic floor muscle contraction? An agreement study about self-perception and physical evaluation of the pelvic muscles contraction by the PERFECT scheme. J Bodyw Mov Ther. 2024 Oct;40:411-416. doi: 10.1016/j.jbmt.2024.04.054. Epub 2024 Apr 28.
PubMed 39593617Laciuga H, Rosenbek JC, Davenport PW, Sapienza CM. Functional outcomes associated with expiratory muscle strength training: narrative review. J Rehabil Res Dev. 2014;51(4):535-46. doi: 10.1682/JRRD.2013.03.0076.
PubMed 25144167Abidi S, Ghram A, Ghroubi S, Ahmaidi S, Elleuch MH, Girard O, Papasavvas T, Laukkanen J, Ben Saad H, Knechtle B, Weiss K, Chlif M. Impact of Urinary Incontinence on Physical Function and Respiratory Muscle Strength in Incontinent Women: A Comparative Study between Urinary Incontinent and Apparently Healthy Women. J Clin Med. 2022 Dec 10;11(24):7344. doi: 10.3390/jcm11247344.
PubMed 36555959Aljuraifani R, Stafford RE, Hall LM, van den Hoorn W, Hodges PW. Task-specific differences in respiration-related activation of deep and superficial pelvic floor muscles. J Appl Physiol (1985). 2019 May 1;126(5):1343-1351. doi: 10.1152/japplphysiol.00704.2018. Epub 2019 Mar 14.
PubMed 30870081
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of Resisted Expiratory Muscle Training for Females Assigned at Birth With Stress Urinary Incontinence: a Pilot Study
- ClinicalTrials.gov ID
- NCT07905586
- Acronym / sponsor ID
- Pelvic floor and EMST
- Conditions
- Stress Urinary Incontinence
- Keywords
- stress urinary incontinence, pelvic floor muscle training, expiratory muscle strength training, pelvic floor rehabilitation, physical therapy
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Thomas Jefferson UniversityUniversity, hospital or other
- Study start
- 1 Jan 2027 (estimated)
- Primary completion
- 30 Jun 2028 (estimated)
- Study completion
- 30 Jun 2028 (estimated)
- First posted
- 29 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this randomized pilot study is to determine whether adding expiratory muscle strength training (EMST) to standard pelvic floor muscle training (PFMT) is feasible and may help improve stress urinary incontinence (SUI) in females assigned at birth, ages 18 to 79. SUI is urine leakage that occurs during activities such as coughing, sneezing, laughing, or exercising.
The main questions this study aims to answer are:
Can participants complete the combined exercise program, and is it acceptable to them?
Does adding EMST to PFMT lead to greater improvements in urinary leakage symptoms and participants' perceived improvement compared with PFMT alone?
Does adding EMST improve breathing muscle strength and pelvic floor muscle activity?
Researchers will enroll 24 participants and randomly assign them to one of two groups:
Group 1: Standard physical therapy, including pelvic floor muscle training.
Group 2: The same physical therapy and pelvic floor muscle training, with the addition of expiratory muscle strength training.
Both groups will receive six weeks of supervised physical therapy, with one session each week. Participants will attend seven study visits over approximately seven weeks, including an initial assessment and six treatment visits.
Participants will:
Complete questionnaires about urinary leakage symptoms and perceived improvement.
Have their breathing muscle strength measured using a test that measures how strongly they can breathe out.
Have pelvic floor muscle activity measured using a surface electromyography (sEMG) sensor.
Perform prescribed home exercises and record their exercise completion in a log.
Participants in both groups will practice pelvic floor muscle exercises at home. Participants in the combined-treatment group will also use a device that provides resistance when breathing out. They will perform five sets of five breaths daily, with resistance based on their measured breathing muscle strength.
Researchers will assess whether participants complete the study visits, follow the home exercise program, complete the study measures, and report satisfaction with the program. They will also monitor any unwanted effects related to the exercises or assessments.
The study will explore whether adding EMST to PFMT may improve urinary leakage symptoms, breathing muscle strength, and pelvic floor muscle activity. Participants may experience improvements, but benefits are not guaranteed. The results will help researchers determine whether a larger study is needed to better evaluate this combined treatment for stress urinary incontinence.
Detailed description
Stress urinary incontinence (SUI) is the involuntary leakage of urine during activities that increase pressure within the abdomen, such as coughing, sneezing, laughing, or exercising. Pelvic floor muscle training (PFMT) is a recommended conservative treatment for SUI. However, treatment outcomes vary, and some individuals have difficulty identifying and correctly contracting their pelvic floor muscles.
The pelvic floor muscles work in coordination with the diaphragm, abdominal wall, and respiratory muscles to regulate pressure within the abdomen. Research has demonstrated coordinated pelvic floor muscle activity during forced expiration, coughing, and other tasks that increase abdominal pressure. Maximal expiratory pressure (MEP), a measure of expiratory muscle strength, has also been associated with SUI severity. These findings suggest that respiratory muscle function may be relevant to urinary continence.
Expiratory muscle strength training (EMST) involves breathing out against resistance using a specialized device. This training may improve expiratory muscle strength and promote coordinated activation of the respiratory and pelvic floor muscles. Although EMST has been studied in other rehabilitation populations, its feasibility and potential effects when combined with PFMT for SUI have not been adequately established.
This pilot randomized controlled study will evaluate the feasibility and acceptability of adding EMST to standard PFMT and estimate preliminary effects on urinary incontinence symptoms, expiratory muscle strength, and pelvic floor muscle activity. The study will also examine relationships between changes in physiological measures and changes in urinary incontinence symptoms. Findings will inform the design of a future, adequately powered randomized controlled trial.
Study Design and Procedures
This study uses a single-site, parallel-group randomized controlled feasibility design. A total of 24 eligible participants will be enrolled and assigned to one of two treatment groups, with 12 participants planned for each group. Participants will complete seven study visits over approximately seven weeks: one baseline assessment followed by six weekly supervised physical therapy sessions.
At the baseline visit, a licensed physical therapist with pelvic health training will conduct a physical therapy evaluation. Participants will complete questionnaires and undergo measurements of expiratory muscle strength and pelvic floor muscle activity. Both groups will receive standardized education about the role of the pelvic floor muscles and bladder in urinary continence.
Participants will complete assessments at baseline (Visit 1), midpoint (Visit 4), and after the intervention (Visit 7). The Global Rating of Change (GROC) questionnaire will be administered at the final visit. Exercise adherence will be monitored using home exercise logs.
Treatment Groups Group 1: Pelvic Floor Muscle Training: Participants will receive standard physical therapy care, including supervised PFMT once weekly for six weeks. A licensed physical therapist with pelvic health training will provide individualized instruction and progress exercises according to the treatment plan.
Participants will complete a home PFMT program consisting initially of five sets of five submaximal repetitions daily. Exercises will progress during the six supervised sessions, with repetitions increasing to as many as 100 per day in gravity-dependent positions, as prescribed by the treating physical therapist.
Group 2: Pelvic Floor Muscle Training Plus Expiratory Muscle Strength Training:
Participants will receive the same supervised physical therapy and PFMT program as Group 1, with the addition of EMST.
EMST will be performed using a calibrated expiratory resistance device. The initial training resistance will be set at 50% of the participant's measured MEP. Participants will perform five sets of five breaths daily as part of their home exercise program. The treating physical therapist will provide instruction on device use and exercise technique. Training intensity will be maintained or progressed according to participant tolerance and the therapist's assessment of safe performance.
Participants in both groups will receive verbal and written instructions for their home exercises and will record exercise completion in a log.
Physiological Assessments:
Maximal Expiratory Pressure: MEP will be measured to characterize expiratory muscle strength and establish the initial resistance for EMST in the combined-treatment group. MEP will be assessed at baseline, midpoint, and after the intervention.
Pelvic Floor Muscle Activity: Pelvic floor muscle activity will be measured using surface electromyography (sEMG) with a vaginal surface sensor. Measurements will be collected during standardized tasks, including quiet breathing, forced expiration, coughing, and maximal voluntary contractions. Assessments will occur at baseline, midpoint, and after the intervention.
The physiological assessments will be used to estimate changes in expiratory muscle strength and pelvic floor muscle activation over the intervention period.
Clinical Assessments:Urinary incontinence symptoms will be assessed using the International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF). This self-report questionnaire will be completed at baseline, midpoint, and after the intervention.
Participants will also complete the GROC at the final visit to describe their perceived change over the course of treatment.
A participant satisfaction questionnaire will be used to assess acceptability. Exercise logs and study records will be used to evaluate adherence, visit completion, and retention.
Feasibility and Safety Monitoring:The primary purpose of this pilot study is to determine whether the combined PFMT and EMST intervention can be implemented as planned and whether participants can complete the study procedures and home exercise program.
Feasibility will be evaluated using recruitment and eligibility information, participant retention, adherence to prescribed home exercises, completion of outcome assessments, and participant satisfaction. Intervention-related adverse events will also be recorded and summarized.
The study team will monitor participants during supervised sessions for symptoms such as pain, dizziness, or excessive fatigue. Exercise intensity will be maintained or reduced if participants cannot complete the prescribed exercises safely and with appropriate technique. Supervised procedures will be stopped if concerning symptoms occur. Participants will be instructed to stop home exercises if they experience significant pain, dizziness, or other unexpected adverse effects and to contact the study team before resuming.
Potential risks include mild muscle soreness or fatigue, temporary dizziness during MEP testing, discomfort during insertion or removal of the vaginal sEMG sensor, and minor irritation, bleeding, or infection associated with sensor placement. Participants may also experience emotional discomfort related to discussing urinary symptoms or undergoing pelvic floor assessment. The study team will use established safety procedures and protect participant confidentiality.
Statistical Analysis
The planned sample of 24 participants, with 12 participants per group, is intended for a pilot feasibility study and preliminary estimation of treatment effects. The study is not designed to establish definitive treatment efficacy.
Feasibility outcomes, including eligibility, retention, adherence, outcome assessment completion, participant satisfaction, and adverse events, will be summarized using appropriate descriptive statistics and 95% confidence intervals.
Linear mixed-effects models will be used to estimate changes in clinical outcomes over time. Models will include treatment group, time, and the group-by-time interaction, with baseline variables included as covariates. Similar models will evaluate changes in MEP and sEMG amplitude.
Participants will also be classified as responders based on a change of 2.52 points on the ICIQ-UI SF, the published minimal clinically important difference specified in the protocol. The proportion of responders in each group will be summarized, and an odds ratio will be calculated to compare responder rates.
Exploratory correlation analyses will examine relationships between physiological and clinical changes. These analyses will assess associations between changes in MEP and ICIQ-UI SF scores, changes in sEMG amplitude and ICIQ-UI SF scores, changes in MEP and GROC scores, and changes in sEMG amplitude and GROC scores. Pearson or Spearman correlation coefficients will be selected according to the distribution of the data.
Linear mixed-effects models will accommodate incomplete repeated outcome measurements under the assumption that data are missing at random.
Expected Contribution
This study will provide preliminary information about the feasibility, acceptability, and potential clinical and physiological effects of adding EMST to standard PFMT for SUI. Results will help estimate treatment effects, variability, adherence, and outcome completion rates to support the planning of a future larger randomized controlled trial. The study may also help clarify whether changes in expiratory muscle strength and pelvic floor muscle activity are associated with changes in urinary incontinence symptoms.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pelvic floor muscle training | Active comparator | Other: Pelvic floor muscle trainingPelvic floor muscle training (PFMT): Participants will be instructed in a home exercise program of PFMT at 5 sets of 5 submaximal repetitions daily. Through the 6 intervention sessions, exercise repetitions will increase to up to 100 per day in gravity dependent positions. |
| Pelvic floor muscle training + expiratory training | Experimental | Other: Pelvic floor muscle training, Other: Expiratory muscle strength trainingExpiratory Muscle Strength Training (EMST): Participants will use a calibrated expiratory resistance device at 50% of MEP, 5 sets of 5 breaths daily. PFMT: Participants will be instructed in a home exercise program of PFMT at 5 sets of 5 submaximal repetitions daily. Through the 6 intervention sessions, exercise repetitions will increase to up to 100 per day in gravity dependent positions. |
Who may qualify
- Ages
- 18 to 79 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Female assigned at birth, 18-79 years of age
- Self-reported stress urinary incontinence for greater than 3 months
- International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF) score >6
- Able to understand the study procedures and provide informed consent
- English language proficiency
Key exclusion criteria (11 listed)
- Males assigned at birth
- Individuals <18 or >80 years old
- Current pregnancy or planning to become pregnant during the study period
- Pelvic, abdominal, esophageal, or head/neck surgery within the previous 6 months
- Healing rib fractures
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pelvic floor muscle trainingPFMT: Participants will be instructed in a home exercise program of pelvic floor muscle training (PFMT) at 5 sets of 5 submaximal repetitions daily. Through the 6 intervention sessions, exercise repetitions will increase to up to 100 per day in gravity dependent positions. | Other | Pelvic floor muscle training, Pelvic floor muscle training + expiratory training |
| Expiratory muscle strength trainingEMST: Participants will use a calibrated expiratory resistance device at 50% of MEP, 5 sets of 5 breaths daily. | Other | Pelvic floor muscle training + expiratory training |
Primary outcome
Attrition
Time frame: This is a post measure after completion of the 7 week study.
Attrition will be assessed as a feasibility outcome to evaluate participant retention throughout the study. Attrition will be defined as the proportion of enrolled participants who discontinue study participation before completing the final study visit (Visit 7). The attrition rate will be calculated by dividing the number of participants who withdraw or discontinue participation before study completion by the total number of participants enrolled, multiplied by 100. The number and percentage of participants who complete the study will also be reported. Reasons for withdrawal or discontinuation will be documented when available. Attrition and retention rates will be summarized descriptively using counts, percentages, and 95% confidence intervals to evaluate the feasibility of participant retention in the study.
Eligibility rates
Time frame: This is a post measure after completion of the 7 week study.
Eligibility rate will be assessed as a feasibility outcome to evaluate the proportion of individuals screened who meet the study's eligibility criteria. The eligibility rate will be calculated by dividing the number of individuals determined to be eligible by the total number of individuals screened and multiplying by 100. Eligibility will be determined based on the study's prespecified inclusion and exclusion criteria, including an ICIQ-UI SF score of at least 6. The number and percentage of individuals who are eligible and ineligible will be summarized descriptively. Reasons for ineligibility will be documented when available. The eligibility rate will be reported as a percentage with a 95% confidence interval to evaluate the feasibility of identifying an appropriate study population.
8 secondary outcomes
Global rating of change
Time frame: at visit 7 which is 6 weeks after baseline.
Maximum expiratory pressure
Time frame: at visit 4 which is 3 weeks after baseline.
Maximum expiratory pressure
Time frame: at visit 7 which is 6 weeks after baseline
surface EMG
Time frame: at visit 4 which is 3 weeks after baseline
surface EMG
Time frame: at visit 7 which is 4 weeks after baseline
International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form
Time frame: Baseline after consent; a score <6 will exclude from inclusion in the study.
International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form
Time frame: at visit 4 which is 3 weeks after baseline.
International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form
Time frame: at visit 7 which is 6 weeks after baseline.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2026.
- Background: PubMed 39593617Barbosa-Silva J, Zanello SC, Jorge CH, Driusso P. Do young women have an accurate perception about their pelvic floor muscle contraction? An agreement study about self-perception and physical evaluation of the pelvic muscles contraction by the PERFECT scheme. J Bodyw Mov Ther. 2024 Oct;40:411-416. doi: 10.1016/j.jbmt.2024.04.054. Epub 2024 Apr 28.
- Background: PubMed 25144167Laciuga H, Rosenbek JC, Davenport PW, Sapienza CM. Functional outcomes associated with expiratory muscle strength training: narrative review. J Rehabil Res Dev. 2014;51(4):535-46. doi: 10.1682/JRRD.2013.03.0076.
- Background: PubMed 36555959Abidi S, Ghram A, Ghroubi S, Ahmaidi S, Elleuch MH, Girard O, Papasavvas T, Laukkanen J, Ben Saad H, Knechtle B, Weiss K, Chlif M. Impact of Urinary Incontinence on Physical Function and Respiratory Muscle Strength in Incontinent Women: A Comparative Study between Urinary Incontinent and Apparently Healthy Women. J Clin Med. 2022 Dec 10;11(24):7344. doi: 10.3390/jcm11247344.
- Background: PubMed 30870081Aljuraifani R, Stafford RE, Hall LM, van den Hoorn W, Hodges PW. Task-specific differences in respiration-related activation of deep and superficial pelvic floor muscles. J Appl Physiol (1985). 2019 May 1;126(5):1343-1351. doi: 10.1152/japplphysiol.00704.2018. Epub 2019 Mar 14.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing Pelvic floor muscle training and Expiratory muscle strength training in people with Stress Urinary Incontinence, run by Thomas Jefferson University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 29 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nicole Dugan, DPT (1-215-512-5140, nicole.dugan@jefferson.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Attrition (time frame: This is a post measure after completion of the 7 week study.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07905586, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2026.