Urinary Incontinence, StressNCT02318251
Stress Urinary Incontinence Physiotherapy
A study testing Involuntary muscle contractions and Voluntary muscle contractions in people with Urinary Incontinence, Stress, run by Bern University of Applied Sciences at 1 site in Switzerland.
Trial summary
The purpose of the present study is to compare two different physiotherapy programs regarding their effect on stress urinary incontinence. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Urinary Incontinence, Stress
- What is being tested?
- Involuntary muscle contractions and Voluntary muscle contractions
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 1 siteSwitzerland
- Study dates
- Jan 2015to 31 Jul 2019
- 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 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Informed Consent as documented by signature
- Stress urinary incontinence (based on the patient's history)
- Mixed incontinence (with dominant SUI)
- 1 year post-partal, parous, nulliparous, pre- or post-menopausal
- BMI 18-30
- Participants must be medically and physically fit for the exercises (running, jumps)
- Stable on systemic or local estrogen treatment for the past 3 months prior to inclusion
Who cannot join
- Urge incontinence or predominant urgency in incontinence
- Prolapse > grade 1 POP-Q (Bump et al., 1996) (uterus, cystocele, rectocele during Valsalva maneuver)
- Pregnancy (test to accomplish)
- Current urinary tract or vaginal infection
- Menstruation on the day of examination
- Lactation period not yet finished
Show all 9Show fewer
- Contraindications for measurements, e.g. acute inflammatory or infectious disease, tumor, fracture
- De novo systemic or local estrogen treatment (< 3 months)
- De novo drug treatment with anticholinergics or other bladder active substances (tricyclic antidepressants, Selective Serotonin Reuptake Inhibitor etc.)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Stress Urinary Incontinence Physiotherapy (SUIP) - A Randomized Controlled Trial With 6-Months Follow-up
The purpose of the present study is to compare two different physiotherapy programs regarding their effect on stress urinary incontinence.
Read the detailed description
Stress urinary incontinence (SUI), the most prevalent type of urinary incontinence, is defined as involuntary loss of urine during effort, or physical exertion (e.g. sporting activities), or upon sneezing, or coughing (Haylen et al, 2010). The overall prevalence of stress, urge, mixed, and any UI was 23.7%, 9.9%, 14.5%, and 49.2%, respectively (Minassian et al, 2008).
Numerous epidemiologic studies show that parity is a risk factor for SUI. Other significant risk factors are age, weight, obesity, chronic pulmonary diseases, ethnic background, and menopause. (Minassian et al, 2008; Matthews et al, 2013) Urinary incontinence affects four times more women (51.1%) than men (13.9%) (Markland et al, 2011). It has an impact on the physical, psychosocial, social, personal, and economic well-being of the affected individuals and of their families. It is associated with a concomitant impairment of activities and participation, and a higher risk of suffering from anxiety disorders has been shown. (Goldstick \& Constantini, 2014; Hunskaar et al, 2003).
SUI is increasingly recognized as a health and economic problem, which not only troubles the affected women, but also implies a substantial economic burden on the health and social services (Hampel et al, 2004).
Consequently, as physiotherapy has proven to be good value for the money, its effectiveness could contribute to a reduction in the cost of health care.
Pelvic floor muscles (PFM) have to be able to contract strongly (Shishido et al, 2008), rapidly and reflexively (Deffieux et al; 2008; Morin et al, 2004) to guarantee continence. The ability of PFM to generate rapid and strong contractions results in the generation of an adequate squeeze pressure in the proximal urethra, which maintains a pressure higher than that in the bladder, thus preventing leakage (Miller et al, 1994). Rapid and reflexive PFM contractions are crucial for maintaining continence, preceding an abrupt rise in the intra-abdominal pressure associated with coughing, sneezing, running, or jumping (Morin et al., 2004). Studies have shown that the PFM function regarding power (rate of force development) was impaired in incontinent women compared to continent women (Deffieux et al, 2008; Morin et al, 2004).
PFM training - defined as a program of repeated voluntary PFM contractions taught and supervised by a health care professional - is the most commonly used physiotherapy treatment for women with SUI and is effective in the treatment of female stress and mixed urinary incontinence and, therefore, is recommended as a first-line therapy (Dumoulin et al, 2014; Bø, 2012). As recommended by the International Consultation on Incontinence (ICI) PFM training should generally be the first step of treatment before surgery (Abrams et al, 2010). However, standard SUI physiotherapy concentrates on voluntary contractions even though the situations provoking SUI such as sneezing, coughing, jumping and running (Haylen et al, 2010) require involuntary fast reflexive pelvic floor muscle contractions. Although training procedures following the concepts of training science and sports medicine are generally well known and widely implemented in rehabilitation and sports (ACSM, 2009; Schmidtbleicher \& Gollhofer, 1991), the optimal, and well standardized training protocol for involuntary, fast, and reflexive PFM contractions still remains unknown.
Consequently, the research group developed a standardized therapy program, which includes the standard therapy and additionally focuses on involuntary fast reflexive PFM contractions. The additional exercises are well known and applied in physiotherapy, however not yet regarding SUI.
Therefore, the aim of the present study is to compare two different physiotherapy programs for women suffering from SUI. Both programs include standard physiotherapy. Both follow the concepts of training science (periodization/ exercise sequence and training of specific muscle strength components). One program focuses on voluntary fast contractions (standard physiotherapy; control group), the other one focuses on involuntary fast reflexive PFM contractions (experimental group).
- Conditions
- Urinary Incontinence, Stress
- Being tested
- Involuntary muscle contractions, Voluntary muscle contractions
- Keywords
- Power, rate of force development, involuntary, reflexive
- 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.
Involuntary muscle contractionsOther
Physiotherapy program focusing on involuntary pelvic floor muscle fast contractions: 9 individual physiotherapies taking place within 16 weeks. During these 16 weeks the participants will perform a home program 3x/week (3x/day) during week 1-5 and 3x/week (1x/day) in week 6-16. In the following 6 months they will perform the home program 3x/week (1x/day). This program includes the standard physiotherapy.
Voluntary muscle contractionsOther
Physiotherapy program (physiotherapy standard program) focusing on voluntary fast contractions: 9 individual physiotherapies taking place within 16 weeks. During these 16 weeks the participants will perform a home program 3x/week (3x/day) during week 1-5 and 3x/week (1x/day) in week 6-16. In the following 6 months they will perform the home program 3x/week (1x/day).
| Study group | Role | What they receive |
|---|---|---|
| Involuntary muscle contractions | Experimental | Standard physiotherapy program (focus on involuntary reflexive pelvic floor muscle contractions) Receives: Other: Involuntary muscle contractions |
| Voluntary muscle contractions | Active comparator | Physiotherapy program (focus on voluntary pelvic floor muscle contractions) Receives: Other: Voluntary muscle contractions |
What is being measured
The primary outcome is the main question the study is designed to answer.
International Consultation on Incontinence Modular Questionnaire - Urinary Incontinence short form (ICIQ-UIsf (short form))
The ICIQ-UIsf provides a brief and robust measure to assess the impact of symptoms of incontinence on quality of life and outcome of treatment
Measured: up to 6 months follow up
Secondary outcomes (4)
Pelvic floor muscle electromyography
Electromyography (EMG) activity measurements during rest, during maximal Voluntary contraction, fast voluntary contractions and during involuntary contractions (squat jumps, counter movement jumps, drop jumps), and during running at 7,9,11 km/h)
Measured: up to 6 months follow up
20-minute PAD-test
The 20 min Pad Test assesses urine loss and leakage volume of the participant
Measured: up to 6 months follow up
International Consultation on Incontinence Modular Questionnaire - Lower Urinary Tract Symptoms Quality of Life (ICIQ-LUTSqol)
The ICIQ-LUTSqol questionnaire evaluates the impact the participant's quality of life, with reference also to social effects
Measured: up to 6 months follow up
International Consultation on Incontinence Modular Questionnaire - Urinary Incontinence short form (ICIQ-UIsf (short form))
See primary outcome
Measured: At the 6 months follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2014 (estimated)
- Study startJan 2015
- Primary completion30 Jun 2018 (estimated)
- Study completion31 Jul 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (18)Papers the sponsor has linked to this study.
- Other trials for Urinary Incontinence, StressStudies 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bern University of Applied Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- Insel Gruppe AG, University Hospital Bern
- Responsible party
- Principal investigator, Lorenz Radlinger, Bern University of Applied Sciences
- Investigators
- Lorenz Radlinger, Prof. Dr., Study director, Bern University of Applied SciencesKuhn Annette, PD Dr. med., Study director, Insel Gruppe AG, University Hospital Bern
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02318251
- Sponsor's protocol ID
- SUIP
- Status last verified
- Feb 2018
- First submitted
- 4 Dec 2014
- Last updated
- 8 Feb 2018
- Results posted
- No
- Data monitoring committee
- Yes
- 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; International Urogynecological Association; International Continence Society. An International Urogynecological Association (IUGA)/International Continence Society (ICS) joint report on the terminology for female pelvic floor dysfunction. Neurourol Urodyn. 2010;29(1):4-20. doi: 10.1002/nau.20798.
PubMed 19941278Minassian VA, Stewart WF, Wood GC. Urinary incontinence in women: variation in prevalence estimates and risk factors. Obstet Gynecol. 2008 Feb;111(2 Pt 1):324-31. doi: 10.1097/01.AOG.0000267220.48987.17.
PubMed 18238969Matthews CA, Whitehead WE, Townsend MK, Grodstein F. Risk factors for urinary, fecal, or dual incontinence in the Nurses' Health Study. Obstet Gynecol. 2013 Sep;122(3):539-45. doi: 10.1097/AOG.0b013e31829efbff.
PubMed 23921863Markland AD, Richter HE, Fwu CW, Eggers P, Kusek JW. Prevalence and trends of urinary incontinence in adults in the United States, 2001 to 2008. J Urol. 2011 Aug;186(2):589-93. doi: 10.1016/j.juro.2011.03.114.
PubMed 21684555Goldstick O, Constantini N. Urinary incontinence in physically active women and female athletes. Br J Sports Med. 2014 Feb;48(4):296-8. doi: 10.1136/bjsports-2012-091880. Epub 2013 May 18.
PubMed 23687004Hunskaar S, Burgio K, Diokno A, Herzog AR, Hjalmas K, Lapitan MC. Epidemiology and natural history of urinary incontinence in women. Urology. 2003 Oct;62(4 Suppl 1):16-23. doi: 10.1016/s0090-4295(03)00755-6.
PubMed 14550833Hampel C, Artibani W, Espuna Pons M, Haab F, Jackson S, Romero J, Gavart S, Papanicolaou S. Understanding the burden of stress urinary incontinence in Europe: a qualitative review of the literature. Eur Urol. 2004 Jul;46(1):15-27. doi: 10.1016/j.eururo.2004.02.003.
PubMed 15183544Shishido K, Peng Q, Jones R, Omata S, Constantinou CE. Influence of pelvic floor muscle contraction on the profile of vaginal closure pressure in continent and stress urinary incontinent women. J Urol. 2008 May;179(5):1917-22. doi: 10.1016/j.juro.2008.01.020. Epub 2008 Mar 18.
PubMed 18353401Deffieux X, Hubeaux K, Porcher R, Ismael SS, Raibaut P, Amarenco G. Abnormal pelvic response to cough in women with stress urinary incontinence. Neurourol Urodyn. 2008;27(4):291-6. doi: 10.1002/nau.20506.
PubMed 17803192Morin M, Bourbonnais D, Gravel D, Dumoulin C, Lemieux MC. Pelvic floor muscle function in continent and stress urinary incontinent women using dynamometric measurements. Neurourol Urodyn. 2004;23(7):668-74. doi: 10.1002/nau.20069.
PubMed 15382183Miller J, Kasper C, Sampselle C. Review of muscle physiology with application to pelvic muscle exercise. Urol Nurs. 1994 Sep;14(3):92-7. No abstract available.
PubMed 7732424Dumoulin C, Hay-Smith EJ, Mac Habee-Seguin G. Pelvic floor muscle training versus no treatment, or inactive control treatments, for urinary incontinence in women. Cochrane Database Syst Rev. 2014 May 14;(5):CD005654. doi: 10.1002/14651858.CD005654.pub3.
PubMed 24823491Bo K. Pelvic floor muscle training in treatment of female stress urinary incontinence, pelvic organ prolapse and sexual dysfunction. World J Urol. 2012 Aug;30(4):437-43. doi: 10.1007/s00345-011-0779-8. Epub 2011 Oct 9.
PubMed 21984473Abrams P, Avery K, Gardener N, Donovan J; ICIQ Advisory Board. The International Consultation on Incontinence Modular Questionnaire: www.iciq.net. J Urol. 2006 Mar;175(3 Pt 1):1063-6; discussion 1066. doi: 10.1016/S0022-5347(05)00348-4.
PubMed 16469618American College of Sports Medicine. American College of Sports Medicine position stand. Progression models in resistance training for healthy adults. Med Sci Sports Exerc. 2009 Mar;41(3):687-708. doi: 10.1249/MSS.0b013e3181915670.
PubMed 19204579
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stress Urinary Incontinence Physiotherapy (SUIP) - A Randomized Controlled Trial With 6-Months Follow-up
- ClinicalTrials.gov ID
- NCT02318251
- Acronym / sponsor ID
- SUIP
- Conditions
- Urinary Incontinence, Stress
- Keywords
- Power, rate of force development, involuntary, reflexive
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 96 participants (actual)
- Lead sponsor
- Bern University of Applied SciencesUniversity, hospital or other
- Collaborators
- Insel Gruppe AG, University Hospital Bern
- Study start
- Jan 2015
- Primary completion
- 30 Jun 2018 (estimated)
- Study completion
- 31 Jul 2019 (estimated)
- First posted
- 17 Dec 2014 (estimated)
- 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 purpose of the present study is to compare two different physiotherapy programs regarding their effect on stress urinary incontinence.
Detailed description
Stress urinary incontinence (SUI), the most prevalent type of urinary incontinence, is defined as involuntary loss of urine during effort, or physical exertion (e.g. sporting activities), or upon sneezing, or coughing (Haylen et al, 2010). The overall prevalence of stress, urge, mixed, and any UI was 23.7%, 9.9%, 14.5%, and 49.2%, respectively (Minassian et al, 2008).
Numerous epidemiologic studies show that parity is a risk factor for SUI. Other significant risk factors are age, weight, obesity, chronic pulmonary diseases, ethnic background, and menopause. (Minassian et al, 2008; Matthews et al, 2013) Urinary incontinence affects four times more women (51.1%) than men (13.9%) (Markland et al, 2011). It has an impact on the physical, psychosocial, social, personal, and economic well-being of the affected individuals and of their families. It is associated with a concomitant impairment of activities and participation, and a higher risk of suffering from anxiety disorders has been shown. (Goldstick \& Constantini, 2014; Hunskaar et al, 2003).
SUI is increasingly recognized as a health and economic problem, which not only troubles the affected women, but also implies a substantial economic burden on the health and social services (Hampel et al, 2004).
Consequently, as physiotherapy has proven to be good value for the money, its effectiveness could contribute to a reduction in the cost of health care.
Pelvic floor muscles (PFM) have to be able to contract strongly (Shishido et al, 2008), rapidly and reflexively (Deffieux et al; 2008; Morin et al, 2004) to guarantee continence. The ability of PFM to generate rapid and strong contractions results in the generation of an adequate squeeze pressure in the proximal urethra, which maintains a pressure higher than that in the bladder, thus preventing leakage (Miller et al, 1994). Rapid and reflexive PFM contractions are crucial for maintaining continence, preceding an abrupt rise in the intra-abdominal pressure associated with coughing, sneezing, running, or jumping (Morin et al., 2004). Studies have shown that the PFM function regarding power (rate of force development) was impaired in incontinent women compared to continent women (Deffieux et al, 2008; Morin et al, 2004).
PFM training - defined as a program of repeated voluntary PFM contractions taught and supervised by a health care professional - is the most commonly used physiotherapy treatment for women with SUI and is effective in the treatment of female stress and mixed urinary incontinence and, therefore, is recommended as a first-line therapy (Dumoulin et al, 2014; Bø, 2012). As recommended by the International Consultation on Incontinence (ICI) PFM training should generally be the first step of treatment before surgery (Abrams et al, 2010). However, standard SUI physiotherapy concentrates on voluntary contractions even though the situations provoking SUI such as sneezing, coughing, jumping and running (Haylen et al, 2010) require involuntary fast reflexive pelvic floor muscle contractions. Although training procedures following the concepts of training science and sports medicine are generally well known and widely implemented in rehabilitation and sports (ACSM, 2009; Schmidtbleicher \& Gollhofer, 1991), the optimal, and well standardized training protocol for involuntary, fast, and reflexive PFM contractions still remains unknown.
Consequently, the research group developed a standardized therapy program, which includes the standard therapy and additionally focuses on involuntary fast reflexive PFM contractions. The additional exercises are well known and applied in physiotherapy, however not yet regarding SUI.
Therefore, the aim of the present study is to compare two different physiotherapy programs for women suffering from SUI. Both programs include standard physiotherapy. Both follow the concepts of training science (periodization/ exercise sequence and training of specific muscle strength components). One program focuses on voluntary fast contractions (standard physiotherapy; control group), the other one focuses on involuntary fast reflexive PFM contractions (experimental group).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Involuntary muscle contractions | Experimental | Other: Involuntary muscle contractionsStandard physiotherapy program (focus on involuntary reflexive pelvic floor muscle contractions) |
| Voluntary muscle contractions | Active comparator | Other: Voluntary muscle contractionsPhysiotherapy program (focus on voluntary pelvic floor muscle contractions) |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Informed Consent as documented by signature
- Stress urinary incontinence (based on the patient's history)
- Mixed incontinence (with dominant SUI)
- 1 year post-partal, parous, nulliparous, pre- or post-menopausal
- BMI 18-30
Key exclusion criteria (9 listed)
- Urge incontinence or predominant urgency in incontinence
- Prolapse > grade 1 POP-Q (Bump et al., 1996) (uterus, cystocele, rectocele during Valsalva maneuver)
- Pregnancy (test to accomplish)
- Current urinary tract or vaginal infection
- Menstruation on the day of examination
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 |
|---|---|---|
| Involuntary muscle contractionsPhysiotherapy program focusing on involuntary pelvic floor muscle fast contractions: 9 individual physiotherapies taking place within 16 weeks. During these 16 weeks the participants will perform a home program 3x/week (3x/day) during week 1-5 and 3x/week (1x/day) in week 6-16. In the following 6 months they will perform the home program 3x/week (1x/day). This program includes the standard physiotherapy. | Other | Involuntary muscle contractions |
| Voluntary muscle contractionsPhysiotherapy program (physiotherapy standard program) focusing on voluntary fast contractions: 9 individual physiotherapies taking place within 16 weeks. During these 16 weeks the participants will perform a home program 3x/week (3x/day) during week 1-5 and 3x/week (1x/day) in week 6-16. In the following 6 months they will perform the home program 3x/week (1x/day). | Other | Voluntary muscle contractions |
Primary outcome
International Consultation on Incontinence Modular Questionnaire - Urinary Incontinence short form (ICIQ-UIsf (short form))
Time frame: up to 6 months follow up
The ICIQ-UIsf provides a brief and robust measure to assess the impact of symptoms of incontinence on quality of life and outcome of treatment
4 secondary outcomes
Pelvic floor muscle electromyography
Time frame: up to 6 months follow up
20-minute PAD-test
Time frame: up to 6 months follow up
International Consultation on Incontinence Modular Questionnaire - Lower Urinary Tract Symptoms Quality of Life (ICIQ-LUTSqol)
Time frame: up to 6 months follow up
International Consultation on Incontinence Modular Questionnaire - Urinary Incontinence short form (ICIQ-UIsf (short form))
Time frame: At the 6 months follow up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2018.
- Background: PubMed 19941278Haylen BT, de Ridder D, Freeman RM, Swift SE, Berghmans B, Lee J, Monga A, Petri E, Rizk DE, Sand PK, Schaer GN; International Urogynecological Association; International Continence Society. An International Urogynecological Association (IUGA)/International Continence Society (ICS) joint report on the terminology for female pelvic floor dysfunction. Neurourol Urodyn. 2010;29(1):4-20. doi: 10.1002/nau.20798.
- Background: PubMed 18238969Minassian VA, Stewart WF, Wood GC. Urinary incontinence in women: variation in prevalence estimates and risk factors. Obstet Gynecol. 2008 Feb;111(2 Pt 1):324-31. doi: 10.1097/01.AOG.0000267220.48987.17.
- Background: PubMed 23921863Matthews CA, Whitehead WE, Townsend MK, Grodstein F. Risk factors for urinary, fecal, or dual incontinence in the Nurses' Health Study. Obstet Gynecol. 2013 Sep;122(3):539-45. doi: 10.1097/AOG.0b013e31829efbff.
- Background: PubMed 21684555Markland AD, Richter HE, Fwu CW, Eggers P, Kusek JW. Prevalence and trends of urinary incontinence in adults in the United States, 2001 to 2008. J Urol. 2011 Aug;186(2):589-93. doi: 10.1016/j.juro.2011.03.114.
- Background: PubMed 23687004Goldstick O, Constantini N. Urinary incontinence in physically active women and female athletes. Br J Sports Med. 2014 Feb;48(4):296-8. doi: 10.1136/bjsports-2012-091880. Epub 2013 May 18.
- Background: PubMed 14550833Hunskaar S, Burgio K, Diokno A, Herzog AR, Hjalmas K, Lapitan MC. Epidemiology and natural history of urinary incontinence in women. Urology. 2003 Oct;62(4 Suppl 1):16-23. doi: 10.1016/s0090-4295(03)00755-6.
- Background: PubMed 15183544Hampel C, Artibani W, Espuna Pons M, Haab F, Jackson S, Romero J, Gavart S, Papanicolaou S. Understanding the burden of stress urinary incontinence in Europe: a qualitative review of the literature. Eur Urol. 2004 Jul;46(1):15-27. doi: 10.1016/j.eururo.2004.02.003.
- Background: PubMed 18353401Shishido K, Peng Q, Jones R, Omata S, Constantinou CE. Influence of pelvic floor muscle contraction on the profile of vaginal closure pressure in continent and stress urinary incontinent women. J Urol. 2008 May;179(5):1917-22. doi: 10.1016/j.juro.2008.01.020. Epub 2008 Mar 18.
- Background: PubMed 17803192Deffieux X, Hubeaux K, Porcher R, Ismael SS, Raibaut P, Amarenco G. Abnormal pelvic response to cough in women with stress urinary incontinence. Neurourol Urodyn. 2008;27(4):291-6. doi: 10.1002/nau.20506.
- Background: PubMed 15382183Morin M, Bourbonnais D, Gravel D, Dumoulin C, Lemieux MC. Pelvic floor muscle function in continent and stress urinary incontinent women using dynamometric measurements. Neurourol Urodyn. 2004;23(7):668-74. doi: 10.1002/nau.20069.
- Background: PubMed 7732424Miller J, Kasper C, Sampselle C. Review of muscle physiology with application to pelvic muscle exercise. Urol Nurs. 1994 Sep;14(3):92-7. No abstract available.
- Background: PubMed 24823491Dumoulin C, Hay-Smith EJ, Mac Habee-Seguin G. Pelvic floor muscle training versus no treatment, or inactive control treatments, for urinary incontinence in women. Cochrane Database Syst Rev. 2014 May 14;(5):CD005654. doi: 10.1002/14651858.CD005654.pub3.
- 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.
Lorenz Radlinger, Prof. Dr. study director
Bern University of Applied Sciences
Kuhn Annette, PD Dr. med. study director
Insel Gruppe AG, University Hospital Bern
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Involuntary muscle contractions and Voluntary muscle contractions in people with Urinary Incontinence, Stress, run by Bern University of Applied Sciences at 1 site in Switzerland.
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 7 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 8 Feb 2018. 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 Switzerland. 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?
Results are not available in the source record.
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?
International Consultation on Incontinence Modular Questionnaire - Urinary Incontinence short form (ICIQ-UIsf (short form)) (time frame: up to 6 months follow up). 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 NCT02318251, which also lists 18 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 8 Feb 2018.