Stress Urinary Incontinence (SUI)NCT06842979
Effects of Home-based High-intensity Inspiratory Muscle Training for Stress Urinary Incontinence
A study testing Inspiratory Muscle Training (IMT) in people with Stress Urinary Incontinence (SUI), run by Izmir University of Economics at 1 site in Turkey (Türkiye).
Trial summary
Strengthening the diaphragm muscle, the roof of the pelvic floor muscles (PFM), may be an alternative intervention in patients suffering from stress urinary incontinence (SUI). This study aims to investigate the effects of home-based telerehabilitation-assisted high-intensity inspiratory muscle training (IMT) on PFM… Read more about this study
- Who is it for?
- Ages 25 to 50 years, women only
- Conditions the study is for
- Stress Urinary Incontinence (SUI)
- What is being tested?
- Inspiratory Muscle Training (IMT)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 22 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 29 May 2023to 10 Feb 2025
- 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 25 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Diagnosed with stress urinary incontinence by a specialized Urologist
- Being female aged between 25 and 50 years
- To have the ability to access and use technological devices required by the study
- Being able to read and write
- Volunteering to research
Who cannot join
- Inability of the participant to understand or perform the procedures proposed during the evaluations or training program.
- Active urinary tract infection,
- pelvic organ prolapse stage 2 and more according to the pelvic organ prolapse staging system (Pelvic Organ Prolapse Quantification System (POP-Q))
- Fecal incontinence,
- Any neurogenic dysfunction of the lower urinary tract
- Conservative or surgical treatment of urinary incontinence in the last 12 months
Show all 16Show fewer
- Previous pelvic floor training
- Less than three months after pregnancy or postpartum
- Having undergone any pelvic floor surgery (hysterectomy, etc.)
- Radiotherapy treatment in the last 12 months
- Severe low back pain or pelvic pain
- Lower extremity orthopaedic problems that may affect the pelvic structure (such as lower extremity inequality, total hip arthroplasty)
- Having any chronic respiratory disease
- Having any neurological disease
- Being in menopause
- Latex allergy
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Izmir University of Economics
Izmir, Balçova, 35330
About this study
Official title: Effects of Home-based Telerehabilitation-assisted High-intensity Inspiratory Muscle Training on Pelvic Floor Muscle Function and Urinary Symptoms in Women With Stress Urinary Incontinence: A Randomized Controlled Study
Strengthening the diaphragm muscle, the roof of the pelvic floor muscles (PFM), may be an alternative intervention in patients suffering from stress urinary incontinence (SUI). This study aims to investigate the effects of home-based telerehabilitation-assisted high-intensity inspiratory muscle training (IMT) on PFM function and urinary symptoms in women with SUI.
Read the detailed description
The IMT protocol consisted of home-based high-intensity daily training - two cycles of 30 breaths with a 1-minute rest between sets, twice a day for 8 weeks using an IMT Threshold device (Threshold IMT Philips® Respironics, Inc). The IMT was performed twice a day, 7 days/week, for 8 weeks. The study group performed IMT at 60% of their baseline MIP and was adjusted weekly based on the modified Borg scale from 4 to 6 regarding respiratory effort performed during the session, while the control group performed a sham-IMT without applied resistance. Patients are evaluated before the inspiratory muscle training and after 8 weeks of training.
- Conditions
- Stress Urinary Incontinence (SUI)
- Being tested
- Inspiratory Muscle Training (IMT), Sham IMT
- Keywords
- inspiratory muscle training, stress urinary incontinence, pelvic floor muscle, telerehabilitation
- 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.
Inspiratory Muscle Training (IMT)Device
The IMT protocol will consist of home-based high-intensity daily training - two cycles of 30 breaths with a 1-min rest between sets, twice a day for 8 weeks using an IMT Threshold device (Threshold IMT Philips® Respironics, Inc). The intensity of the training will be set to 60% of each patient's maximal inspiratory pressure measured and adjusted weekly based on the modified Borg scale from 4 to 6 regarding respiratory effort performed during the session. Patients were also informed to perform knack maneuver in daily activities that may cause sudden intra-abdominal pressure overload.
Sham IMTDevice
The IMT protocol will consist of home-based daily training - two cycles of 30 breaths with a 1-min rest between sets, twice a day for 8 weeks using an IMT Threshold device (Threshold IMT Philips® Respironics, Inc). The intensity of the training will be set to the lowest intensity of the IMT Threshold device. Patients were also informed to perform knack maneuver in daily activities that may cause sudden intra-abdominal pressure overload.
| Study group | Role | What they receive |
|---|---|---|
| Study Group | Experimental | Patients who perform inspiratory muscle training (IMT) with %60 loading Receives: Device: Inspiratory Muscle Training (IMT) |
| Sham Group | Sham comparator | Patients who perform Sham IMT Receives: Device: Sham IMT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of Pelvic floor muscle functions with Pressure feedbacks
Pressure feedbacks: Pelvic muscle functions were evaluated with pressure feedback of pelvic muscle using a biofeedback device (Myomed 932®- Enraf-Nonius, Delf, The Netherlands), and recorded in hPa (Hectopascal).
- Manual muscle test: Manual muscle test was evaluated using the modified Oxford Scale that ranges from 1 to 5. Higher values on this scale indicate better muscle strength.
Measured: 8 weeks
Change of Pelvic floor muscle functions with Manual muscle test
The manual muscle test was evaluated using the modified Oxford Scale, which ranges from 1 to 5. Higher values on this scale indicate better muscle strength.
Measured: 8 weeks
Secondary outcomes (4)
Urogenital Distress Inventory-Short Form
Urinary symptom was assessed with the Urogenital Distress Inventory-Short Form (range: 0-100) Higher values on this scale indicate worse symptoms.
Measured: 8 weeks
International Consultation on Incontinence Questionnaire-Short Form
Urinary incontinence symptom and its effect on the quality of life was assessed with the International Consultation on Incontinence Questionnaire-Short Form (range: 0-21) Higher values on this scale indicate worse symptoms.
Measured: 8 weeks
Incontinence Severity Index
Urinary incontinence severity was assessed with the Incontinence Severity Index (range: 1-12). Higher values on this scale indicate worse symptoms.
Measured: 8 weeks
Inspiratory muscle strength
The Inspiratory muscle strength was evaluated by maximum inspiratory pressure which was assessed with a digital mouth pressure meter device (MicroRPM, Micro Medical Ltd., Rochester, Kent, United Kingdom), and recorded in cmH2O (centimeter-water).
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2025
- Study start29 May 2023
- Primary completion3 Feb 2025
- Study completion10 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Stress Urinary Incontinence (SUI)Studies 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
- Model description
- This study was designed as a prospective and Randomized Controlled experimental study. Participants were randomly divided into two groups in a 1:1 ratio; the study group and the control group.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Izmir University of Economics
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ridvan Aktan, Izmir University of Economics
- Investigators
- RIDVAN AKTAN, Asst. Prof., Principal investigator, Izmir University of Economics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06842979
- Sponsor's protocol ID
- 2023/16-03
- Status last verified
- Feb 2025
- First submitted
- 11 Feb 2025
- Last updated
- 24 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Haylen BT, de Ridder D, Freeman RM, Swift SE, Berghmans B, Lee J, Monga A, Petri E, Rizk DE, Sand PK, Schaer GN. An International Urogynecological Association (IUGA)/International Continence Society (ICS) joint report on the terminology for female pelvic floor dysfunction. Int Urogynecol J. 2010 Jan;21(1):5-26. doi: 10.1007/s00192-009-0976-9. Epub 2009 Nov 25.
PubMed 19937315Hodges PW, Gandevia SC. Changes in intra-abdominal pressure during postural and respiratory activation of the human diaphragm. J Appl Physiol (1985). 2000 Sep;89(3):967-76. doi: 10.1152/jappl.2000.89.3.967.
PubMed 10956340Talasz H, Kofler M, Kalchschmid E, Pretterklieber M, Lechleitner M. Breathing with the pelvic floor? Correlation of pelvic floor muscle function and expiratory flows in healthy young nulliparous women. Int Urogynecol J. 2010 Apr;21(4):475-81. doi: 10.1007/s00192-009-1060-1. Epub 2009 Dec 8.
PubMed 19997721Talasz H, Kremser C, Kofler M, Kalchschmid E, Lechleitner M, Rudisch A. Phase-locked parallel movement of diaphragm and pelvic floor during breathing and coughing-a dynamic MRI investigation in healthy females. Int Urogynecol J. 2011 Jan;22(1):61-8. doi: 10.1007/s00192-010-1240-z. Epub 2010 Aug 31.
PubMed 20809211Al-Bilbeisi F, McCOOL FD. Diaphragm recruitment during nonrespiratory activities. Am J Respir Crit Care Med. 2000 Aug;162(2 Pt 1):456-9. doi: 10.1164/ajrccm.162.2.9908059.
PubMed 10934070CAMPBELL EJ, GREEN JH. The variations in intra-abdominal pressure and the activity of the abdominal muscles during breathing; a study in man. J Physiol. 1953 Nov 28;122(2):282-90. doi: 10.1113/jphysiol.1953.sp004999. No abstract available.
PubMed 13118539Neumann P, Gill V. Pelvic floor and abdominal muscle interaction: EMG activity and intra-abdominal pressure. Int Urogynecol J Pelvic Floor Dysfunct. 2002;13(2):125-32. doi: 10.1007/s001920200027.
PubMed 12054180Sapsford RR, Hodges PW, Richardson CA, Cooper DH, Markwell SJ, Jull GA. Co-activation of the abdominal and pelvic floor muscles during voluntary exercises. Neurourol Urodyn. 2001;20(1):31-42. doi: 10.1002/1520-6777(2001)20:13.0.co;2-p.
PubMed 11135380Saunders SW, Rath D, Hodges PW. Postural and respiratory activation of the trunk muscles changes with mode and speed of locomotion. Gait Posture. 2004 Dec;20(3):280-90. doi: 10.1016/j.gaitpost.2003.10.003.
PubMed 15531175Azevedo IG, Sousa SLO, Viana ESR, Dantas DS, Maciel ACC, Da Camara SMA. Relationship between symptomatic pelvic organ prolapse and respiratory muscle strength in middle-aged and older women in Northeast Brazil: a cross-sectional study. Physiother Theory Pract. 2021 Jun;37(6):755-761. doi: 10.1080/09593985.2019.1642428. Epub 2019 Jul 11.
PubMed 31294670Hodges PW, Sapsford R, Pengel LH. Postural and respiratory functions of the pelvic floor muscles. Neurourol Urodyn. 2007;26(3):362-71. doi: 10.1002/nau.20232.
PubMed 17304528Deffieux X, Hubeaux K, Porcher R, Ismael SS, Raibaut P, Amarenco G. Pelvic floor muscle activity during coughing: altered pattern in women with stress urinary incontinence. Urology. 2007 Sep;70(3):443-7; discussion 447-8. doi: 10.1016/j.urology.2007.03.084.
PubMed 17905093
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Home-based Telerehabilitation-assisted High-intensity Inspiratory Muscle Training on Pelvic Floor Muscle Function and Urinary Symptoms in Women With Stress Urinary Incontinence: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT06842979
- Acronym / sponsor ID
- 2023/16-03
- Conditions
- Stress Urinary Incontinence (SUI)
- Keywords
- inspiratory muscle training, stress urinary incontinence, pelvic floor muscle, telerehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Izmir University of EconomicsUniversity, hospital or other
- Study start
- 29 May 2023 (actual)
- Primary completion
- 3 Feb 2025 (actual)
- Study completion
- 10 Feb 2025 (actual)
- First posted
- 24 Feb 2025 (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.
Strengthening the diaphragm muscle, the roof of the pelvic floor muscles (PFM), may be an alternative intervention in patients suffering from stress urinary incontinence (SUI). This study aims to investigate the effects of home-based telerehabilitation-assisted high-intensity inspiratory muscle training (IMT) on PFM function and urinary symptoms in women with SUI.
Detailed description
The IMT protocol consisted of home-based high-intensity daily training - two cycles of 30 breaths with a 1-minute rest between sets, twice a day for 8 weeks using an IMT Threshold device (Threshold IMT Philips® Respironics, Inc). The IMT was performed twice a day, 7 days/week, for 8 weeks. The study group performed IMT at 60% of their baseline MIP and was adjusted weekly based on the modified Borg scale from 4 to 6 regarding respiratory effort performed during the session, while the control group performed a sham-IMT without applied resistance. Patients are evaluated before the inspiratory muscle training and after 8 weeks of training.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- This study was designed as a prospective and Randomized Controlled experimental study. Participants were randomly divided into two groups in a 1:1 ratio; the study group and the control group.
| Arm | Type | Receives |
|---|---|---|
| Study Group | Experimental | Device: Inspiratory Muscle Training (IMT)Patients who perform inspiratory muscle training (IMT) with %60 loading |
| Sham Group | Sham comparator | Device: Sham IMTPatients who perform Sham IMT |
Who may qualify
- Ages
- 25 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Diagnosed with stress urinary incontinence by a specialized Urologist
- Being female aged between 25 and 50 years
- To have the ability to access and use technological devices required by the study
- Being able to read and write
- Volunteering to research
Key exclusion criteria (16 listed)
- Inability of the participant to understand or perform the procedures proposed during the evaluations or training program.
- Active urinary tract infection,
- pelvic organ prolapse stage 2 and more according to the pelvic organ prolapse staging system (Pelvic Organ Prolapse Quantification System (POP-Q))
- Fecal incontinence,
- Any neurogenic dysfunction of the lower urinary tract
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 |
|---|---|---|
| Inspiratory Muscle Training (IMT)The IMT protocol will consist of home-based high-intensity daily training - two cycles of 30 breaths with a 1-min rest between sets, twice a day for 8 weeks using an IMT Threshold device (Threshold IMT Philips® Respironics, Inc). The intensity of the training will be set to 60% of each patient's maximal inspiratory pressure measured and adjusted weekly based on the modified Borg scale from 4 to 6 regarding respiratory effort performed during the session. Patients were also informed to perform knack maneuver in daily activities that may cause sudden intra-abdominal pressure overload. | Device | Study Group |
| Sham IMTThe IMT protocol will consist of home-based daily training - two cycles of 30 breaths with a 1-min rest between sets, twice a day for 8 weeks using an IMT Threshold device (Threshold IMT Philips® Respironics, Inc). The intensity of the training will be set to the lowest intensity of the IMT Threshold device. Patients were also informed to perform knack maneuver in daily activities that may cause sudden intra-abdominal pressure overload. | Device | Sham Group |
Primary outcome
Change of Pelvic floor muscle functions with Pressure feedbacks
Time frame: 8 weeks
Pressure feedbacks: Pelvic muscle functions were evaluated with pressure feedback of pelvic muscle using a biofeedback device (Myomed 932®- Enraf-Nonius, Delf, The Netherlands), and recorded in hPa (Hectopascal). - Manual muscle test: Manual muscle test was evaluated using the modified Oxford Scale that ranges from 1 to 5. Higher values on this scale indicate better muscle strength.
Change of Pelvic floor muscle functions with Manual muscle test
Time frame: 8 weeks
The manual muscle test was evaluated using the modified Oxford Scale, which ranges from 1 to 5. Higher values on this scale indicate better muscle strength.
4 secondary outcomes
Urogenital Distress Inventory-Short Form
Time frame: 8 weeks
International Consultation on Incontinence Questionnaire-Short Form
Time frame: 8 weeks
Incontinence Severity Index
Time frame: 8 weeks
Inspiratory muscle strength
Time frame: 8 weeks
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 24 Feb 2025.
- Background: PubMed 19937315Haylen BT, de Ridder D, Freeman RM, Swift SE, Berghmans B, Lee J, Monga A, Petri E, Rizk DE, Sand PK, Schaer GN. An International Urogynecological Association (IUGA)/International Continence Society (ICS) joint report on the terminology for female pelvic floor dysfunction. Int Urogynecol J. 2010 Jan;21(1):5-26. doi: 10.1007/s00192-009-0976-9. Epub 2009 Nov 25.
- Background: PubMed 10956340Hodges PW, Gandevia SC. Changes in intra-abdominal pressure during postural and respiratory activation of the human diaphragm. J Appl Physiol (1985). 2000 Sep;89(3):967-76. doi: 10.1152/jappl.2000.89.3.967.
- Background: PubMed 19997721Talasz H, Kofler M, Kalchschmid E, Pretterklieber M, Lechleitner M. Breathing with the pelvic floor? Correlation of pelvic floor muscle function and expiratory flows in healthy young nulliparous women. Int Urogynecol J. 2010 Apr;21(4):475-81. doi: 10.1007/s00192-009-1060-1. Epub 2009 Dec 8.
- Background: PubMed 20809211Talasz H, Kremser C, Kofler M, Kalchschmid E, Lechleitner M, Rudisch A. Phase-locked parallel movement of diaphragm and pelvic floor during breathing and coughing-a dynamic MRI investigation in healthy females. Int Urogynecol J. 2011 Jan;22(1):61-8. doi: 10.1007/s00192-010-1240-z. Epub 2010 Aug 31.
- Background: PubMed 10934070Al-Bilbeisi F, McCOOL FD. Diaphragm recruitment during nonrespiratory activities. Am J Respir Crit Care Med. 2000 Aug;162(2 Pt 1):456-9. doi: 10.1164/ajrccm.162.2.9908059.
- Background: PubMed 13118539CAMPBELL EJ, GREEN JH. The variations in intra-abdominal pressure and the activity of the abdominal muscles during breathing; a study in man. J Physiol. 1953 Nov 28;122(2):282-90. doi: 10.1113/jphysiol.1953.sp004999. No abstract available.
- Background: PubMed 12054180Neumann P, Gill V. Pelvic floor and abdominal muscle interaction: EMG activity and intra-abdominal pressure. Int Urogynecol J Pelvic Floor Dysfunct. 2002;13(2):125-32. doi: 10.1007/s001920200027.
- Background: PubMed 11135380Sapsford RR, Hodges PW, Richardson CA, Cooper DH, Markwell SJ, Jull GA. Co-activation of the abdominal and pelvic floor muscles during voluntary exercises. Neurourol Urodyn. 2001;20(1):31-42. doi: 10.1002/1520-6777(2001)20:13.0.co;2-p.
- Background: PubMed 15531175Saunders SW, Rath D, Hodges PW. Postural and respiratory activation of the trunk muscles changes with mode and speed of locomotion. Gait Posture. 2004 Dec;20(3):280-90. doi: 10.1016/j.gaitpost.2003.10.003.
- Background: PubMed 31294670Azevedo IG, Sousa SLO, Viana ESR, Dantas DS, Maciel ACC, Da Camara SMA. Relationship between symptomatic pelvic organ prolapse and respiratory muscle strength in middle-aged and older women in Northeast Brazil: a cross-sectional study. Physiother Theory Pract. 2021 Jun;37(6):755-761. doi: 10.1080/09593985.2019.1642428. Epub 2019 Jul 11.
- Background: PubMed 17304528Hodges PW, Sapsford R, Pengel LH. Postural and respiratory functions of the pelvic floor muscles. Neurourol Urodyn. 2007;26(3):362-71. doi: 10.1002/nau.20232.
- Background: PubMed 17905093Deffieux X, Hubeaux K, Porcher R, Ismael SS, Raibaut P, Amarenco G. Pelvic floor muscle activity during coughing: altered pattern in women with stress urinary incontinence. Urology. 2007 Sep;70(3):443-7; discussion 447-8. doi: 10.1016/j.urology.2007.03.084.
- 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.
RIDVAN AKTAN, Asst. Prof. principal investigator
Izmir University of Economics
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Inspiratory Muscle Training (IMT) in people with Stress Urinary Incontinence (SUI), run by Izmir University of Economics 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 5 inclusion and 16 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 24 Feb 2025. 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. Some participants in this study may receive a placebo. 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 of Pelvic floor muscle functions with Pressure feedbacks (time frame: 8 weeks). 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 NCT06842979, which also lists 12 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 24 Feb 2025; AzTrials last refreshed its copy on 26 Oct 2026.