Stress Urinary Incontinence Physiotherapy

NCT02318251 | Unknown DMC

• 1 other identifier: SUIP
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of the present study is to compare two different physiotherapy programs regarding their effect on stress urinary incontinence.

Conditions

Urinary Incontinence, Stress

Keywords

Power, rate of force development; involuntary; reflexive

Outcome Measures

Primary Outcomes (1)

• 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

  up to 6 months follow up

Secondary Outcomes (4)

• Pelvic floor muscle electromyography

  up to 6 months follow up

• 20-minute PAD-test

  up to 6 months follow up

• International Consultation on Incontinence Modular Questionnaire - Lower Urinary Tract Symptoms Quality of Life (ICIQ-LUTSqol)

  up to 6 months follow up

• International Consultation on Incontinence Modular Questionnaire - Urinary Incontinence short form (ICIQ-UIsf (short form))

  At the 6 months follow up

Other Outcomes (2)

• Pelvic floor manual muscle testing

  up to 6 months follow up

• Home exercise adherence

  up to 6 months follow up

Study Arms (2)

Involuntary muscle contractions

EXPERIMENTAL

Standard physiotherapy program (focus on involuntary reflexive pelvic floor muscle contractions)

Other: Involuntary muscle contractions

Voluntary muscle contractions

ACTIVE COMPARATOR

Physiotherapy program (focus on voluntary pelvic floor muscle contractions)

Other: Voluntary muscle contractions

Interventions

Involuntary muscle contractions OTHER

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.

Involuntary muscle contractions

Voluntary muscle contractions OTHER

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).

Voluntary muscle contractions

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Informed Consent as documented by signature
• Stress urinary incontinence (based on the patient's history)
• Mixed incontinence (with dominant SUI)
• year post-partal, parous, nulliparous, pre- or post-menopausal
• BMI 18-30
• Participants must be medically and physically fit for the exercises (running, jumps)

You may not qualify if:

• 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
• 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.)

Sponsors & Collaborators

• Bern University of Applied Sciences: lead
• Insel Gruppe AG, University Hospital Bern: collaborator

Study Sites (1)

University Hospital, Inselspital, Bern

Bern, 3010, Switzerland

Location

Related Publications (18)

• 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.

  PMID: 19941278 BACKGROUND

• Minassian 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.

  PMID: 18238969 BACKGROUND

• Matthews 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.

  PMID: 23921863 BACKGROUND

• Markland 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.

  PMID: 21684555 BACKGROUND

• Goldstick 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.

  PMID: 23687004 BACKGROUND

• Hunskaar 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.

  PMID: 14550833 BACKGROUND

• Hampel 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.

  PMID: 15183544 BACKGROUND

• Shishido 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.

  PMID: 18353401 BACKGROUND

• Deffieux 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.

  PMID: 17803192 BACKGROUND

• Morin 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.

  PMID: 15382183 BACKGROUND

• Miller 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.

  PMID: 7732424 BACKGROUND

• Dumoulin 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.

  PMID: 24823491 BACKGROUND

• Bo 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.

  PMID: 21984473 BACKGROUND

• Abrams 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.

  PMID: 16469618 BACKGROUND

• American 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.

  PMID: 19204579 BACKGROUND

• Schmidtbleicher D, Gollhofer A. [Specific methods of strength training also in rehabilitation]. Sportverletz Sportschaden. 1991 Sep;5(3):135-41. doi: 10.1055/s-2007-993577. German.

  PMID: 1759194 BACKGROUND

• Hay-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.

  PMID: 39704322 DERIVED

• Luginbuehl H, Lehmann C, Baeyens JP, Kuhn A, Radlinger L. Involuntary reflexive pelvic floor muscle training in addition to standard training versus standard training alone for women with stress urinary incontinence: study protocol for a randomized controlled trial. Trials. 2015 Nov 17;16:524. doi: 10.1186/s13063-015-1051-0.

  PMID: 26573847 DERIVED

MeSH Terms

Conditions

Urinary Incontinence, Stress

Condition Hierarchy (Ancestors)

Urinary Incontinence; Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Lorenz Radlinger, Prof. Dr.

  Bern University of Applied Sciences

  STUDY DIRECTOR

• Kuhn Annette, PD Dr. med.

  Insel Gruppe AG, University Hospital Bern

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr. Lorenz Radlinger

Study Record Dates

• First Submitted: December 4, 2014
• First Posted: December 17, 2014
• Study Start: January 1, 2015
• Primary Completion: June 30, 2018
• Study Completion: July 31, 2019
• Last Updated: February 8, 2018

Record last verified: 2018-02

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)