Pelvic Floor Exercise Before Surgery in Women With Pelvic Organ Prolapse (CONTRAPOP)
December 2, 2021 updated by: St. Olavs Hospital
The lifetime risk for a woman to undergo surgery for either vaginal prolapse or urinary incontinence is high. There are many different surgical techniques for treatment of prolapse, but there is a lack of knowledge about factors that contribute to objective result and patient satisfaction after surgery.
The aim of the study is to investigate factors that could be related to patient satisfaction and objective result such as pelvic floor muscle contractility/strength and muscle injury, objective measures of prolapse and women's symptoms. This study will investigate whether systematic pelvic floor exercise and life style advise before surgery can improve outcomes after surgery for either vaginal prolapse. Another aim is to determine an ultrasound scale for measure of pelvic floor muscle contraction.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
151
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Trondheim, Norway
- St Olavs Hospital
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- referred to surgery for urogenital prolapse
- informed consent
Exclusion Criteria:
- not able to communicate in Norwegian or English
- not able or willing to sign informed consent
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Pre-surgery exercise
pelvic floor exercises individually and in groups
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In preparation for surgery, patients receive individual information by a physiotherapist on pelvic floor anatomy and correct pelvic floor contraction.
Patients are told to do the following pelvic floor exercises 3 times a day: 8-12 maximal contractions, hold contractions during 10 seconds, and 3 fast contractions after each long contraction.
In addition exercise in groups with skilled physical therapists once a week during 12 weeks.
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Other: Waiting list
wait as usual until surgery
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patients wait as usual until surgery without special treatment.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pelvic floor muscle strength assessed by palpation
Time Frame: 9 months
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Muscle strength is evaluated using 6 point modified Oxford Scale (MOS) range 0-5.
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9 months
|
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Pelvic floor muscle strength assessed by ultrasound
Time Frame: 9 months
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Changes in pelvic floor muscle at rest and during pelvic floor contraction, measured in mm and calculated proportional change
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9 months
|
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Symptoms of pelvic floor disorders
Time Frame: 9 months
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Symptoms of pelvic floor disorders assessed by validated questionnaire (PDFI-20)
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9 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pelvic floor muscle strength assessed by perineometry
Time Frame: 9 months
|
measuring the pressure with vaginal manometry in cm H2O during pelvic floor contraction
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9 months
|
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Pelvic floor muscle strength assessed by electromyography
Time Frame: 9 months
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Assessed by vaginal surface electrode during pelvic floor contraction, measured in mV
|
9 months
|
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Proportion of anatomical pelvic organ prolapse
Time Frame: 9 months
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Assessment with the Pelvic Organ Prolapse Quantification (POP-Q) System
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9 months
|
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Proportion of anatomical sphincter ani defect
Time Frame: 9 months
|
Anatomical sphincter ani defect assessed by transperineal ultrasound
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9 months
|
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Proportion of levator ani muscle trauma
Time Frame: 9 months
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Assessed by transperineal ultrasound on contraction and Valsalva
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9 months
|
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Assessment of pelvic organ mobility as a measure of pelvic organ function/dysfunction
Time Frame: 9 months
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Movement of the pelvic organs during Valsalva and contraction
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9 months
|
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Imaging of synthetic implants assessed by ultrasound
Time Frame: 9 months
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Registration of implants after pelvic floor surgery and their relations to anatomical structures in mm.
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9 months
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Symptoms of pelvic floor disorders
Time Frame: 9 months
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Symptoms of pelvic floor disorders assessed by validated questionnaire (PFIQ-7)
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9 months
|
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Symptoms of pelvic floor disorders
Time Frame: 9 months
|
Symptoms of pelvic floor disorders assessed by visual analogue scale (VAS 1-10)
|
9 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Study Director: Kjell Å Salvesen, md prof, St Olavs Hospital University Hospital Trondheim
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Nyhus MO, Oversand SH, Salvesen O, Salvesen KA, Mathew S, Volloyhaug I. Ultrasound assessment of pelvic floor muscle contraction: reliability and development of an ultrasound-based contraction scale. Ultrasound Obstet Gynecol. 2020 Jan;55(1):125-131. doi: 10.1002/uog.20382. Epub 2019 Dec 13.
- Nyhus MO, Mathew S, Salvesen O, Salvesen KA, Stafne S, Volloyhaug I. Effect of preoperative pelvic floor muscle training on pelvic floor muscle contraction and symptomatic and anatomical pelvic organ prolapse after surgery: randomized controlled trial. Ultrasound Obstet Gynecol. 2020 Jul;56(1):28-36. doi: 10.1002/uog.22007. Epub 2020 Jun 9.
- Mathew S, Nyhus MO, Salvesen O, Salvesen KA, Stafne SN, Volloyhaug I. The effect of preoperative pelvic floor muscle training on urinary and colorectal-anal distress in women undergoing pelvic organ prolapse surgery-a randomized controlled trial. Int Urogynecol J. 2021 Oct;32(10):2787-2794. doi: 10.1007/s00192-021-04684-3. Epub 2021 Feb 13.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 1, 2017
Primary Completion (Actual)
June 26, 2019
Study Completion (Actual)
June 26, 2019
Study Registration Dates
First Submitted
February 22, 2017
First Submitted That Met QC Criteria
February 22, 2017
First Posted (Actual)
February 27, 2017
Study Record Updates
Last Update Posted (Actual)
December 17, 2021
Last Update Submitted That Met QC Criteria
December 2, 2021
Last Verified
December 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2015/1751
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.