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Trial record 1 of 1 for:    NCT02318251
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Stress Urinary Incontinence Physiotherapy

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ClinicalTrials.gov Identifier: NCT02318251
Recruitment Status : Unknown
Verified February 2018 by Lorenz Radlinger, Bern University of Applied Sciences.
Recruitment status was:  Active, not recruiting
First Posted : December 17, 2014
Last Update Posted : February 8, 2018
Sponsor:
Collaborator:
University Hospital Inselspital, Berne
Information provided by (Responsible Party):
Lorenz Radlinger, Bern University of Applied Sciences

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

Condition or disease Intervention/treatment Phase
Urinary Incontinence, Stress Other: Involuntary muscle contractions Other: Voluntary muscle contractions Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 96 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Stress Urinary Incontinence Physiotherapy (SUIP) - A Randomized Controlled Trial With 6-Months Follow-up
Study Start Date : January 2015
Estimated Primary Completion Date : June 30, 2018
Estimated Study Completion Date : July 31, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Involuntary muscle contractions
Standard physiotherapy program (focus on involuntary reflexive pelvic floor muscle contractions)
Other: Involuntary muscle contractions
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.

Active Comparator: Voluntary muscle contractions
Physiotherapy program (focus on voluntary pelvic floor muscle contractions)
Other: Voluntary muscle contractions
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).




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Pelvic floor muscle electromyography [ Time Frame: up to 6 months follow up ]
    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)

  2. 20-minute PAD-test [ Time Frame: up to 6 months follow up ]
    The 20 min Pad Test assesses urine loss and leakage volume of the participant

  3. International Consultation on Incontinence Modular Questionnaire - Lower Urinary Tract Symptoms Quality of Life (ICIQ-LUTSqol) [ Time Frame: up to 6 months follow up ]
    The ICIQ-LUTSqol questionnaire evaluates the impact the participant's quality of life, with reference also to social effects

  4. International Consultation on Incontinence Modular Questionnaire - Urinary Incontinence short form (ICIQ-UIsf (short form)) [ Time Frame: At the 6 months follow up ]
    See primary outcome


Other Outcome Measures:
  1. Pelvic floor manual muscle testing [ Time Frame: up to 6 months follow up ]
    Pelvic floor muscle strength will be digitally assessed by the Oxford grading scale.

  2. Home exercise adherence [ Time Frame: up to 6 months follow up ]
    Adherence to the home exercise program will be assessed, i.e. how many of the total of therapy sessions will be completed individually



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02318251


Locations
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Switzerland
University Hospital, Inselspital, Bern
Bern, Switzerland, 3010
Sponsors and Collaborators
Bern University of Applied Sciences
University Hospital Inselspital, Berne
Investigators
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Study Director: Lorenz Radlinger, Prof. Dr. Bern University of Applied Sciences
Study Director: Kuhn Annette, PD Dr. med. University Hospital Inselspital, Bern
Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Lorenz Radlinger, Prof. Dr. Lorenz Radlinger, Bern University of Applied Sciences
ClinicalTrials.gov Identifier: NCT02318251    
Other Study ID Numbers: SUIP
First Posted: December 17, 2014    Key Record Dates
Last Update Posted: February 8, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Lorenz Radlinger, Bern University of Applied Sciences:
Power, rate of force development
involuntary
reflexive
Additional relevant MeSH terms:
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Urinary Incontinence
Enuresis
Urinary Incontinence, Stress
Urination Disorders
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Behavioral Symptoms
Elimination Disorders
Mental Disorders