Pelvic Floor Exercise Before Surgery in Women With Pelvic Organ Prolapse (CONTRAPOP)
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|ClinicalTrials.gov Identifier: NCT03064750|
Recruitment Status : Recruiting
First Posted : February 27, 2017
Last Update Posted : January 10, 2019
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.
|Condition or disease||Intervention/treatment||Phase|
|Pelvic Organ Prolapse Pelvic Floor Disorders||Behavioral: pelvic floor exercises Other: Waiting list||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||330 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Pelvic Floor Exercise Before Surgery in Women With Pelvic Organ Prolapse|
|Actual Study Start Date :||January 1, 2017|
|Estimated Primary Completion Date :||July 1, 2019|
|Estimated Study Completion Date :||July 1, 2019|
Experimental: Pre-surgery exercise
pelvic floor exercises individually and in groups
Behavioral: pelvic floor exercises
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.
wait as usual until surgery
Other: Waiting list
patients wait as usual until surgery without special treatment.
- Pelvic floor muscle strength assessed by palpation [ Time Frame: 9 months ]Muscle strength is evaluated using 6 point modified Oxford Scale (MOS) range 0-5.
- Pelvic floor muscle strength assessed by ultrasound [ Time Frame: 9 months ]Changes in pelvic floor muscle at rest and during pelvic floor contraction, measured in mm and calculated proportional change
- Symptoms of pelvic floor disorders [ Time Frame: 9 months ]Symptoms of pelvic floor disorders assessed by validated questionnaire (PDFI-20)
- Pelvic floor muscle strength assessed by perineometry [ Time Frame: 9 months ]measuring the pressure with vaginal manometry in cm H2O during pelvic floor contraction
- Pelvic floor muscle strength assessed by electromyography [ Time Frame: 9 months ]Assessed by vaginal surface electrode during pelvic floor contraction, measured in mV
- Proportion of anatomical pelvic organ prolapse [ Time Frame: 9 months ]Assessment with the Pelvic Organ Prolapse Quantification (POP-Q) System
- Proportion of anatomical sphincter ani defect [ Time Frame: 9 months ]Anatomical sphincter ani defect assessed by transperineal ultrasound
- Proportion of levator ani muscle trauma [ Time Frame: 9 months ]Assessed by transperineal ultrasound on contraction and Valsalva
- Assessment of pelvic organ mobility as a measure of pelvic organ function/dysfunction [ Time Frame: 9 months ]Movement of the pelvic organs during Valsalva and contraction
- Imaging of synthetic implants assessed by ultrasound [ Time Frame: 9 months ]Registration of implants after pelvic floor surgery and their relations to anatomical structures in mm.
- Symptoms of pelvic floor disorders [ Time Frame: 9 months ]Symptoms of pelvic floor disorders assessed by validated questionnaire (PFIQ-7)
- Symptoms of pelvic floor disorders [ Time Frame: 9 months ]Symptoms of pelvic floor disorders assessed by visual analogue scale (VAS 1-10)
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): NCT03064750
|Contact: Maria Øyasæter Nyhusfirstname.lastname@example.org|
|Contact: Ingrid Volløyhaug, md email@example.com|
|St Olavs Hospital||Recruiting|
|Contact: Maria Øyasæter Nyhus firstname.lastname@example.org|
|Contact: Ingrid Volløyhaug, md email@example.com|
|Study Director:||Kjell Å Salvesen, md prof||St Olavs Hospital University Hospital Trondheim|