Stress Urinary IncontinenceNCT05293886
Comparison of Two Different Pelvic Floor Muscle Training Programs in Stress Urinary Incontinence
A study testing Classical Pelvic Floor Muscle Training and Functional Pelvic Floor Muscle Training in people with Stress Urinary Incontinence, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial summary
Pelvic floor muscle training (PFMT) is indicated as a first-line treatment for stress urinary incontinence. PFMT aims to improve pelvic floor muscle strength, endurance and relaxation ability or a combination of these. PFMT is a structured and customized exercise program. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Stress Urinary Incontinence
- What is being tested?
- Classical Pelvic Floor Muscle Training and Functional Pelvic Floor Muscle Training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Nov 2021to 30 Apr 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients suffering from stress urinary incontinence or SUI predominant Mixed Urinary Incontinence according to the 3 Incontinence Questionnaire (3IQ)
- Body mass index <35 kg/m²
- Individuals over the age of 18 (with a Mini Mental Test score ≥ 24 for individuals over the age of 65)
Who cannot join
- Patients with pure urge incontinence, urge predominant mixed urinary incontinence or neurogenic bladder
- Pregnancy or suspected of pregnancy
- Those who have given birth in the last 1 year
- Being virgin
- Those who have had abdomino-pelvic surgery in the last 6 months, and/or those who have received abdomino-pelvic radiotherapy
- Those with urinary tract infection, recurrent urinary tract infection, diagnosis of interstitial cystitis
Show all 14Show fewer
- Any orthopedic problem that will hinder exercise
- Patients over 65 years of age with a mini mental test score < 24
- Patients with Pelvic Organ Prolapse grade ≥ Stage 2
- Those who have received treatment for urinary incontinence in the last 6 months
- Those who have uncontrolled diabetes and hypertension, severe systemic disease
- Those who have a neurological disease that will affect the urinary system
- Those who have started a new drug that will affect bladder functions in the last 1 month
- The strength of the pelvic floor muscles in digital examination is <2 according to the Modified Oxford Scale score.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of The Effects of Two Different Pelvic Floor Muscle Training Programs in Women With Stress Urinary İncontinence
Pelvic floor muscle training (PFMT) is indicated as a first-line treatment for stress urinary incontinence. PFMT aims to improve pelvic floor muscle strength, endurance and relaxation ability or a combination of these. PFMT is a structured and customized exercise program. Pelvic floor muscles work in synchronization with many muscles and pelvic floor muscle function is supported by synergistic muscles. Relationships between the functions of pelvic floor muscles and synergistic muscle groups have been reported in the literature. However, studies comparing the efficacy of PFMT and combined training of these muscles are limited and more studies are needed.
Therefore the aim of this study is to compare the effects of isolated PFMT and functional PFMT in women with stress urinary incontinence.
Read the detailed description
Our study is designed as a parallel group, randomized clinical trial. Participants who meet the inclusion criteria will be assigned randomly to one of the study groups. The participants in the 1st group will be given classical PFMT, and the participants in the 2nd group will be given functional PFMT. The study period is 8 weeks for each individual participating in the study. All participants will be called for control every 2 weeks and progress will be made in exercise programs in accordance with the protocol.
At the beginning of the study, demographic information, physical characteristics, smoking habit, primary and secondary urinary symptoms and their duration, obstetric history, menstrual and menopausal status, comorbidities, drugs used and, if any, the effects of these drugs on the urinary system, previous UI treatments and their duration will be recorded.
For individuals over 65 years of age, Mini Mental Test will be applied in terms of cooperation suitability for the research.
The objective severity of incontinence will be assessed with the 1-hour pad test. The subjective severity of incontinence and its impact on life will be evaluated with the International Incontinence Consultation Questionnaire-Short Form (ICIQ-UI SF). The King's Health Questionnaire (KHQ) will be used to investigate the effects of interventions on the sub-dimensions of quality of life. With the Patient Global Impression of Severity Scale and the Patient Global Impression of Change Scale, the individual's perception of severity and recovery of UI will be evaluated. Vaginal palpation will be performed to determine whether individuals can voluntarily contract their pelvic floor muscles and to teach correct contraction before pelvic floor muscle training. Outcome measurements will be recorded at the beginning of the study, at the end of the 4th week and at the end of the 8th week. Participants will be given an exercise diary to increase motivation and exercise adherence.
- Conditions
- Stress Urinary Incontinence
- Being tested
- Classical Pelvic Floor Muscle Training, Functional Pelvic Floor Muscle Training
- 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.
Classical Pelvic Floor Muscle TrainingOther
In the first 2 weeks of classical pelvic floor muscle training, individuals will perform 3 sets of 10 maximal voluntary pelvic floor muscle contraction exercises and 20 submaximal voluntary pelvic floor muscle contraction exercises per day. In every 2-week control, the number of sets will be increased by one set.
Functional Pelvic Floor Muscle TrainingOther
Functional pelvic floor muscle training will be started with 3 exercises (toe tap, bridge and clamshall exercises), each exercise will be performed with 1 set and 30 repetitions. In every 2-week control, the number of exercises will be increased by one. Cat-cow exercise will be added at 3-4th weeks, squats will be added at 5-6th weeks, and lunges will be added at 7-8th weeks.
| Study group | Role | What they receive |
|---|---|---|
| Classical Pelvic Floor Muscle Training | Active comparator | In the first 2 weeks of classical pelvic floor muscle training, individuals will perform 3 sets of 10 maximal voluntary pelvic floor muscle contraction exercises and 20 submaximal voluntary pelvic floor muscle contraction exercises per day. In every 2-week control, the number of sets will be increased by one set. Receives: Other: Classical Pelvic Floor Muscle Training |
| Functional Pelvic Floor Muscle Training | Experimental | Functional pelvic floor muscle training will be started with 3 exercises (toe tap, bridge and clamshall exercises), each exercise will be performed with 1 set and 30 repetitions. In every 2-week control, the number of exercises will be increased by one. Cat-cow exercise will be added at 3-4th weeks, squats will be added at 5-6th weeks, and lunges will be added at 7-8th weeks. Receives: Other: Functional Pelvic Floor Muscle Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Symptom Severity and Impact of Incontinence on Life by International Urinary Incontinence Consultation Questionnaire Short Form
International Urinary Incontinence Consultation Questionnaire Short Form will be used to evaluate the change in symptom severity and impact of incontinence on life. Score ranges are 1-5 (slight), 6- 2 (moderate), 13-18 (severe) and 19-21 (very severe). Lower scores mean a better outcome for this questionnaire form.
Measured: Change in International Urinary Incontinence Consultation Questionnaire Short Form score from baseline to end of 8th week
Secondary outcomes (4)
Incontinence Severity by 1-hour pad test
1-hour pad test will be used to evaluate the incontinence severity. There is no minimum and maximum values. Lower scores mean a better outcome.
Measured: Change in incontinence severity from baseline to end of 8th week.
The Impact of Incontinence on Quality of Life by King Health Questionnaire
King Health Questionnaire will be used to evaluate the effect of incontinence on quality of life. Minimum value is 0 and maximum value is 130. Lower scores mean a better outcome.
Measured: Change in King Health Questionnaire score from baseline to end of 8th week.
Participant's Perception of Symptom Severity by Patient Global Impression of Severity Scale
Patient Global Impression of Severity Scale will be used to evaluate the participant's perception of symptom severity. Score ranges are 1 to 4. Lower scores mean a better outcome.
Measured: Change in Patient Global Impression of Severity Scale score from baseline to end of 8th week.
Participant's Perception of Recovery by Patient Global Impression of Change Scale
Patient Global Impression of Change Scale will be used to evaluate the participant's perception of recovery. Score ranges are 1 to 7. Lower scores mean a better outcome.
Measured: Change in Patient Global Impression of Change Scale score from baseline to end of 8th week.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2022
- Study start15 Nov 2021
- Primary completion30 Apr 2023
- Study completion30 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Stress Urinary IncontinenceStudies of the same condition, open and under way.
- 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
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, SERAP ÖZGÜL, Hacettepe University
- Investigators
- Serap Özgül, Prof, Principal investigator, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05293886
- Sponsor's protocol ID
- KA-21107
- Status last verified
- Mar 2024
- First submitted
- 15 Mar 2022
- Last updated
- 4 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bo K, Frawley HC, Haylen BT, Abramov Y, Almeida FG, Berghmans B, Bortolini M, Dumoulin C, Gomes M, McClurg D, Meijlink J, Shelly E, Trabuco E, Walker C, Wells A. An International Urogynecological Association (IUGA)/International Continence Society (ICS) joint report on the terminology for the conservative and nonpharmacological management of female pelvic floor dysfunction. Neurourol Urodyn. 2017 Feb;36(2):221-244. doi: 10.1002/nau.23107. Epub 2016 Dec 5.
PubMed 27918122Folstein MF, Folstein SE, McHugh PR. "Mini-mental state". A practical method for grading the cognitive state of patients for the clinician. J Psychiatr Res. 1975 Nov;12(3):189-98. doi: 10.1016/0022-3956(75)90026-6. No abstract available.
PubMed 1202204Gungen C, Ertan T, Eker E, Yasar R, Engin F. [Reliability and validity of the standardized Mini Mental State Examination in the diagnosis of mild dementia in Turkish population]. Turk Psikiyatri Derg. 2002 Winter;13(4):273-81. Turkish.
PubMed 12794644Jorgensen L, Lose G, Andersen JT. One-hour pad-weighing test for objective assessment of female urinary incontinence. Obstet Gynecol. 1987 Jan;69(1):39-42.
PubMed 3796918Avery K, Donovan J, Peters TJ, Shaw C, Gotoh M, Abrams P. ICIQ: a brief and robust measure for evaluating the symptoms and impact of urinary incontinence. Neurourol Urodyn. 2004;23(4):322-30. doi: 10.1002/nau.20041.
PubMed 15227649Kelleher CJ, Cardozo LD, Khullar V, Salvatore S. A new questionnaire to assess the quality of life of urinary incontinent women. Br J Obstet Gynaecol. 1997 Dec;104(12):1374-9. doi: 10.1111/j.1471-0528.1997.tb11006.x.
PubMed 9422015Kaya S, Akbayrak T, Toprak Celenay S, Dolgun A, Ekici G, Beksac S. Reliability and validity of the Turkish King's Health Questionnaire in women with urinary incontinence. Int Urogynecol J. 2015 Dec;26(12):1853-9. doi: 10.1007/s00192-015-2786-6. Epub 2015 Jul 26.
PubMed 26209953Fischer MC, Huckabay C, Nitti VW. The male perineal sling: assessment and prediction of outcome. J Urol. 2007 Apr;177(4):1414-8. doi: 10.1016/j.juro.2006.11.061.
PubMed 17382743Yalcin I, Bump RC. Validation of two global impression questionnaires for incontinence. Am J Obstet Gynecol. 2003 Jul;189(1):98-101. doi: 10.1067/mob.2003.379.
PubMed 12861145Hay-Smith EJC, Starzec-Proserpio M, Moller B, Aldabe D, Cacciari L, Pitangui ACR, Vesentini G, Woodley SJ, Dumoulin C, Frawley HC, Jorge CH, Morin M, Wallace SA, Weatherall M. Comparisons of approaches to pelvic floor muscle training for urinary incontinence in women. Cochrane Database Syst Rev. 2024 Dec 20;12(12):CD009508. doi: 10.1002/14651858.CD009508.pub2.
PubMed 39704322
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of The Effects of Two Different Pelvic Floor Muscle Training Programs in Women With Stress Urinary İncontinence
- ClinicalTrials.gov ID
- NCT05293886
- Acronym / sponsor ID
- KA-21107
- Conditions
- Stress Urinary Incontinence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 15 Nov 2021 (actual)
- Primary completion
- 30 Apr 2023 (actual)
- Study completion
- 30 Apr 2023 (actual)
- First posted
- 24 Mar 2022 (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.
Pelvic floor muscle training (PFMT) is indicated as a first-line treatment for stress urinary incontinence. PFMT aims to improve pelvic floor muscle strength, endurance and relaxation ability or a combination of these. PFMT is a structured and customized exercise program. Pelvic floor muscles work in synchronization with many muscles and pelvic floor muscle function is supported by synergistic muscles. Relationships between the functions of pelvic floor muscles and synergistic muscle groups have been reported in the literature. However, studies comparing the efficacy of PFMT and combined training of these muscles are limited and more studies are needed.
Therefore the aim of this study is to compare the effects of isolated PFMT and functional PFMT in women with stress urinary incontinence.
Detailed description
Our study is designed as a parallel group, randomized clinical trial. Participants who meet the inclusion criteria will be assigned randomly to one of the study groups. The participants in the 1st group will be given classical PFMT, and the participants in the 2nd group will be given functional PFMT. The study period is 8 weeks for each individual participating in the study. All participants will be called for control every 2 weeks and progress will be made in exercise programs in accordance with the protocol.
At the beginning of the study, demographic information, physical characteristics, smoking habit, primary and secondary urinary symptoms and their duration, obstetric history, menstrual and menopausal status, comorbidities, drugs used and, if any, the effects of these drugs on the urinary system, previous UI treatments and their duration will be recorded.
For individuals over 65 years of age, Mini Mental Test will be applied in terms of cooperation suitability for the research.
The objective severity of incontinence will be assessed with the 1-hour pad test. The subjective severity of incontinence and its impact on life will be evaluated with the International Incontinence Consultation Questionnaire-Short Form (ICIQ-UI SF). The King's Health Questionnaire (KHQ) will be used to investigate the effects of interventions on the sub-dimensions of quality of life. With the Patient Global Impression of Severity Scale and the Patient Global Impression of Change Scale, the individual's perception of severity and recovery of UI will be evaluated. Vaginal palpation will be performed to determine whether individuals can voluntarily contract their pelvic floor muscles and to teach correct contraction before pelvic floor muscle training. Outcome measurements will be recorded at the beginning of the study, at the end of the 4th week and at the end of the 8th week. Participants will be given an exercise diary to increase motivation and exercise adherence.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Classical Pelvic Floor Muscle Training | Active comparator | Other: Classical Pelvic Floor Muscle TrainingIn the first 2 weeks of classical pelvic floor muscle training, individuals will perform 3 sets of 10 maximal voluntary pelvic floor muscle contraction exercises and 20 submaximal voluntary pelvic floor muscle contraction exercises per day. In every 2-week control, the number of sets will be increased by one set. |
| Functional Pelvic Floor Muscle Training | Experimental | Other: Functional Pelvic Floor Muscle TrainingFunctional pelvic floor muscle training will be started with 3 exercises (toe tap, bridge and clamshall exercises), each exercise will be performed with 1 set and 30 repetitions. In every 2-week control, the number of exercises will be increased by one. Cat-cow exercise will be added at 3-4th weeks, squats will be added at 5-6th weeks, and lunges will be added at 7-8th weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients suffering from stress urinary incontinence or SUI predominant Mixed Urinary Incontinence according to the 3 Incontinence Questionnaire (3IQ)
- Body mass index <35 kg/m²
- Individuals over the age of 18 (with a Mini Mental Test score ≥ 24 for individuals over the age of 65)
Key exclusion criteria (14 listed)
- Patients with pure urge incontinence, urge predominant mixed urinary incontinence or neurogenic bladder
- Pregnancy or suspected of pregnancy
- Those who have given birth in the last 1 year
- Being virgin
- Those who have had abdomino-pelvic surgery in the last 6 months, and/or those who have received abdomino-pelvic radiotherapy
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 |
|---|---|---|
| Classical Pelvic Floor Muscle TrainingIn the first 2 weeks of classical pelvic floor muscle training, individuals will perform 3 sets of 10 maximal voluntary pelvic floor muscle contraction exercises and 20 submaximal voluntary pelvic floor muscle contraction exercises per day. In every 2-week control, the number of sets will be increased by one set. | Other | Classical Pelvic Floor Muscle Training |
| Functional Pelvic Floor Muscle TrainingFunctional pelvic floor muscle training will be started with 3 exercises (toe tap, bridge and clamshall exercises), each exercise will be performed with 1 set and 30 repetitions. In every 2-week control, the number of exercises will be increased by one. Cat-cow exercise will be added at 3-4th weeks, squats will be added at 5-6th weeks, and lunges will be added at 7-8th weeks. | Other | Functional Pelvic Floor Muscle Training |
Primary outcome
Change in Symptom Severity and Impact of Incontinence on Life by International Urinary Incontinence Consultation Questionnaire Short Form
Time frame: Change in International Urinary Incontinence Consultation Questionnaire Short Form score from baseline to end of 8th week
International Urinary Incontinence Consultation Questionnaire Short Form will be used to evaluate the change in symptom severity and impact of incontinence on life. Score ranges are 1-5 (slight), 6- 2 (moderate), 13-18 (severe) and 19-21 (very severe). Lower scores mean a better outcome for this questionnaire form.
4 secondary outcomes
Incontinence Severity by 1-hour pad test
Time frame: Change in incontinence severity from baseline to end of 8th week.
The Impact of Incontinence on Quality of Life by King Health Questionnaire
Time frame: Change in King Health Questionnaire score from baseline to end of 8th week.
Participant's Perception of Symptom Severity by Patient Global Impression of Severity Scale
Time frame: Change in Patient Global Impression of Severity Scale score from baseline to end of 8th week.
Participant's Perception of Recovery by Patient Global Impression of Change Scale
Time frame: Change in Patient Global Impression of Change Scale score from baseline to end of 8th week.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2024.
- Background: PubMed 27918122Bo K, Frawley HC, Haylen BT, Abramov Y, Almeida FG, Berghmans B, Bortolini M, Dumoulin C, Gomes M, McClurg D, Meijlink J, Shelly E, Trabuco E, Walker C, Wells A. An International Urogynecological Association (IUGA)/International Continence Society (ICS) joint report on the terminology for the conservative and nonpharmacological management of female pelvic floor dysfunction. Neurourol Urodyn. 2017 Feb;36(2):221-244. doi: 10.1002/nau.23107. Epub 2016 Dec 5.
- Background: PubMed 1202204Folstein MF, Folstein SE, McHugh PR. "Mini-mental state". A practical method for grading the cognitive state of patients for the clinician. J Psychiatr Res. 1975 Nov;12(3):189-98. doi: 10.1016/0022-3956(75)90026-6. No abstract available.
- Background: PubMed 12794644Gungen C, Ertan T, Eker E, Yasar R, Engin F. [Reliability and validity of the standardized Mini Mental State Examination in the diagnosis of mild dementia in Turkish population]. Turk Psikiyatri Derg. 2002 Winter;13(4):273-81. Turkish.
- Background: PubMed 3796918Jorgensen L, Lose G, Andersen JT. One-hour pad-weighing test for objective assessment of female urinary incontinence. Obstet Gynecol. 1987 Jan;69(1):39-42.
- Background: PubMed 15227649Avery K, Donovan J, Peters TJ, Shaw C, Gotoh M, Abrams P. ICIQ: a brief and robust measure for evaluating the symptoms and impact of urinary incontinence. Neurourol Urodyn. 2004;23(4):322-30. doi: 10.1002/nau.20041.
- Background: PubMed 9422015Kelleher CJ, Cardozo LD, Khullar V, Salvatore S. A new questionnaire to assess the quality of life of urinary incontinent women. Br J Obstet Gynaecol. 1997 Dec;104(12):1374-9. doi: 10.1111/j.1471-0528.1997.tb11006.x.
- Background: PubMed 26209953Kaya S, Akbayrak T, Toprak Celenay S, Dolgun A, Ekici G, Beksac S. Reliability and validity of the Turkish King's Health Questionnaire in women with urinary incontinence. Int Urogynecol J. 2015 Dec;26(12):1853-9. doi: 10.1007/s00192-015-2786-6. Epub 2015 Jul 26.
- Background: PubMed 17382743Fischer MC, Huckabay C, Nitti VW. The male perineal sling: assessment and prediction of outcome. J Urol. 2007 Apr;177(4):1414-8. doi: 10.1016/j.juro.2006.11.061.
- Background: PubMed 12861145Yalcin I, Bump RC. Validation of two global impression questionnaires for incontinence. Am J Obstet Gynecol. 2003 Jul;189(1):98-101. doi: 10.1067/mob.2003.379.
- Derived from this study: PubMed 39704322Hay-Smith EJC, Starzec-Proserpio M, Moller B, Aldabe D, Cacciari L, Pitangui ACR, Vesentini G, Woodley SJ, Dumoulin C, Frawley HC, Jorge CH, Morin M, Wallace SA, Weatherall M. Comparisons of approaches to pelvic floor muscle training for urinary incontinence in women. Cochrane Database Syst Rev. 2024 Dec 20;12(12):CD009508. doi: 10.1002/14651858.CD009508.pub2.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Serap Özgül, Prof principal investigator
Hacettepe University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Classical Pelvic Floor Muscle Training and Functional Pelvic Floor Muscle Training in people with Stress Urinary Incontinence, run by Hacettepe University at 1 site in Turkey (Türkiye).
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 3 inclusion and 14 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: finished, as of the sponsor's last update on 4 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Symptom Severity and Impact of Incontinence on Life by International Urinary Incontinence Consultation Questionnaire Short Form (time frame: Change in International Urinary Incontinence Consultation Questionnaire Short Form score from baseline to end of 8th week). 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 NCT05293886, which also lists 10 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 4 Mar 2024.