NCT03064750: CONTRAPOP

Pelvic Floor Exercise Before Surgery in Women With Pelvic Organ Prolapse

Completed NA Last updated 17 December 2021

What this trial tests

NA trial testing pelvic floor exercises in Pelvic Organ Prolapse in 151 participants. Completed in 26 June 2019.

Timeline

1 January 2017

Primary endpoint
26 June 2019

26 June 2019

Quick facts

Lead sponsor	St. Olavs Hospital
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	151
Start date	1 January 2017
Primary completion	26 June 2019
Estimated completion	26 June 2019
Sites	1 location across Norway

Drugs / interventions tested

• pelvic floor exercises
• Waiting list

Conditions studied

• Pelvic Organ Prolapse — all drugs for Pelvic Organ Prolapse →
• Pelvic Floor Disorders — all drugs for Pelvic Floor Disorders →

Sponsor

St. Olavs Hospital

Who can join

18 and older, female only, with Pelvic Organ Prolapse or Pelvic Floor Disorders. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Are levator hiatal dimensions in mid-pregnancy associated with mode of delivery?
   Bjerkholt FF, Nyhus MØ, Mathew S, Volløyhaug I. · · 2022 · cited 2× · PMID 35230480 · DOI 10.1007/s00192-022-05111-x