Pelvic Floor Exercise Before Surgery in Women With Pelvic Organ Prolapse

Not Applicable

Completed

• Conditions: Pelvic Floor Disorders; Pelvic Organ Prolapse
• Interventions: Other: Waiting list; Behavioral: pelvic floor exercises

• Registration Number: NCT03064750
• Lead Sponsor: St. Olavs Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-01-01
• Study First Submitted: 2017-02-22
• Study First Submitted QC: 2017-02-22
• Study First Posted: 2017-02-27
• Primary Completion: 2019-06-26
• Study Completion: 2019-06-26
• Status Verified: 2021-12
• Last Update Submitted: 2021-12-02
• Last Update Posted: 2021-12-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 151

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Waiting list	Waiting list	wait as usual until surgery
Pre-surgery exercise	pelvic floor exercises	pelvic floor exercises individually and in groups

Primary Outcome Measures

Name	Time	Method
Pelvic floor muscle strength assessed by palpation	9 months	Muscle strength is evaluated using 6 point modified Oxford Scale (MOS) range 0-5.
Pelvic floor muscle strength assessed by ultrasound	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	9 months	Symptoms of pelvic floor disorders assessed by validated questionnaire (PDFI-20)

Secondary Outcome Measures

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

Trial Locations

Locations (1)

St Olavs Hospital; 🇳🇴 Trondheim, Norway