Pelvic Floor Exercise Before Surgery in Women With Pelvic Organ Prolapse

Study Overview
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Brief Summary
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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.

Official Title
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Pelvic Floor Exercise Before Surgery in Women With Pelvic Organ Prolapse

Conditions
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Pelvic Organ Prolapse, Pelvic Floor Disorders

Intervention / Treatment
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* Behavioral: pelvic floor exercises
* Other: Waiting list


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pre-surgery exercise<br>pelvic floor exercises individually and in groups | Behavioral: pelvic floor exercises<br>* 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.<br>|
| Other: Waiting list<br>wait as usual until surgery | Other: Waiting list<br>* patients wait as usual until surgery without special treatment.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pelvic floor muscle strength assessed by palpation | Muscle strength is evaluated using 6 point modified Oxford Scale (MOS) range 0-5. | 9 months | 
| Pelvic floor muscle strength assessed by ultrasound | Changes in pelvic floor muscle at rest and during pelvic floor contraction, measured in mm and calculated proportional change | 9 months | 
| Symptoms of pelvic floor disorders | Symptoms of pelvic floor disorders assessed by validated questionnaire (PDFI-20) | 9 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pelvic floor muscle strength assessed by perineometry | measuring the pressure with vaginal manometry in cm H2O during pelvic floor contraction | 9 months | 
| Pelvic floor muscle strength assessed by electromyography | Assessed by vaginal surface electrode during pelvic floor contraction, measured in mV | 9 months | 
| Proportion of anatomical pelvic organ prolapse | Assessment with the Pelvic Organ Prolapse Quantification (POP-Q) System | 9 months | 
| Proportion of anatomical sphincter ani defect | Anatomical sphincter ani defect assessed by transperineal ultrasound | 9 months | 
| Proportion of levator ani muscle trauma | Assessed by transperineal ultrasound on contraction and Valsalva | 9 months | 
| Assessment of pelvic organ mobility as a measure of pelvic organ function/dysfunction | Movement of the pelvic organs during Valsalva and contraction | 9 months | 
| Imaging of synthetic implants assessed by ultrasound | Registration of implants after pelvic floor surgery and their relations to anatomical structures in mm. | 9 months | 
| Symptoms of pelvic floor disorders | Symptoms of pelvic floor disorders assessed by validated questionnaire (PFIQ-7) | 9 months | 
| Symptoms of pelvic floor disorders | Symptoms of pelvic floor disorders assessed by visual analogue scale (VAS 1-10) | 9 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Exercise Therapy, Pelvic Floor, Preoperative Care