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Pelvic Floor Exercise Before Surgery in Women With Pelvic Organ Prolapse (CONTRAPOP)

Primary Purpose

Pelvic Organ Prolapse, Pelvic Floor Disorders

Status
Completed
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
pelvic floor exercises
Waiting list
Sponsored by
St. Olavs Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pelvic Organ Prolapse focused on measuring Exercise Therapy, Pelvic Floor, Preoperative Care

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • St Olavs Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Pre-surgery exercise

Waiting list

Arm Description

pelvic floor exercises individually and in groups

wait as usual until surgery

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
February 22, 2017
Last Updated
December 2, 2021
Sponsor
St. Olavs Hospital
Collaborators
Norwegian University of Science and Technology
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1. Study Identification

Unique Protocol Identification Number
NCT03064750
Brief Title
Pelvic Floor Exercise Before Surgery in Women With Pelvic Organ Prolapse
Acronym
CONTRAPOP
Official Title
Pelvic Floor Exercise Before Surgery in Women With Pelvic Organ Prolapse
Study Type
Interventional

2. Study Status

Record Verification Date
December 2021
Overall Recruitment Status
Completed
Study Start Date
January 1, 2017 (Actual)
Primary Completion Date
June 26, 2019 (Actual)
Study Completion Date
June 26, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
St. Olavs Hospital
Collaborators
Norwegian University of Science and Technology

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pelvic Organ Prolapse, Pelvic Floor Disorders
Keywords
Exercise Therapy, Pelvic Floor, Preoperative Care

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
151 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Pre-surgery exercise
Arm Type
Experimental
Arm Description
pelvic floor exercises individually and in groups
Arm Title
Waiting list
Arm Type
Other
Arm Description
wait as usual until surgery
Intervention Type
Behavioral
Intervention Name(s)
pelvic floor exercises
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Waiting list
Intervention Description
patients wait as usual until surgery without special treatment.
Primary Outcome Measure Information:
Title
Pelvic floor muscle strength assessed by palpation
Description
Muscle strength is evaluated using 6 point modified Oxford Scale (MOS) range 0-5.
Time Frame
9 months
Title
Pelvic floor muscle strength assessed by ultrasound
Description
Changes in pelvic floor muscle at rest and during pelvic floor contraction, measured in mm and calculated proportional change
Time Frame
9 months
Title
Symptoms of pelvic floor disorders
Description
Symptoms of pelvic floor disorders assessed by validated questionnaire (PDFI-20)
Time Frame
9 months
Secondary Outcome Measure Information:
Title
Pelvic floor muscle strength assessed by perineometry
Description
measuring the pressure with vaginal manometry in cm H2O during pelvic floor contraction
Time Frame
9 months
Title
Pelvic floor muscle strength assessed by electromyography
Description
Assessed by vaginal surface electrode during pelvic floor contraction, measured in mV
Time Frame
9 months
Title
Proportion of anatomical pelvic organ prolapse
Description
Assessment with the Pelvic Organ Prolapse Quantification (POP-Q) System
Time Frame
9 months
Title
Proportion of anatomical sphincter ani defect
Description
Anatomical sphincter ani defect assessed by transperineal ultrasound
Time Frame
9 months
Title
Proportion of levator ani muscle trauma
Description
Assessed by transperineal ultrasound on contraction and Valsalva
Time Frame
9 months
Title
Assessment of pelvic organ mobility as a measure of pelvic organ function/dysfunction
Description
Movement of the pelvic organs during Valsalva and contraction
Time Frame
9 months
Title
Imaging of synthetic implants assessed by ultrasound
Description
Registration of implants after pelvic floor surgery and their relations to anatomical structures in mm.
Time Frame
9 months
Title
Symptoms of pelvic floor disorders
Description
Symptoms of pelvic floor disorders assessed by validated questionnaire (PFIQ-7)
Time Frame
9 months
Title
Symptoms of pelvic floor disorders
Description
Symptoms of pelvic floor disorders assessed by visual analogue scale (VAS 1-10)
Time Frame
9 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kjell Å Salvesen, md prof
Organizational Affiliation
St Olavs Hospital University Hospital Trondheim
Official's Role
Study Director
Facility Information:
Facility Name
St Olavs Hospital
City
Trondheim
Country
Norway

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
31237722
Citation
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.
Results Reference
background
PubMed Identifier
32144829
Citation
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.
Results Reference
result
PubMed Identifier
33580809
Citation
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.
Results Reference
result

Learn more about this trial

Pelvic Floor Exercise Before Surgery in Women With Pelvic Organ Prolapse

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