CONTRAPOP: Pelvic Floor Exercise Before Surgery in Women With Pelvic Organ Prolapse

• Sponsor: St. Olavs Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT03064750
• Collaborator: Norwegian University of Science and Technology (Other)
• Enrollment: 151
• Location: 1
• Arms: 2
• Actual Duration (Months): 29.8
• Patients Per Site Per Month: 5.1

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Pelvic Organ Prolapse; Pelvic Floor Disorders	Behavioral: pelvic floor exercises; Other: Waiting list	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 151 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Pelvic Floor Exercise Before Surgery in Women With Pelvic Organ Prolapse
• Actual Study Start Date: Jan 1, 2017
• Actual Primary Completion Date: Jun 26, 2019
• Actual Study Completion Date: Jun 26, 2019

Arms and Interventions

Arm	Intervention/Treatment
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.
Other: Waiting list wait as usual until surgery	Other: Waiting list; patients wait as usual until surgery without special treatment.

Outcome Measures

Primary Outcome Measures

1. Pelvic floor muscle strength assessed by palpation [9 months]

   Muscle strength is evaluated using 6 point modified Oxford Scale (MOS) range 0-5.

2. 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

3. Symptoms of pelvic floor disorders [9 months]

   Symptoms of pelvic floor disorders assessed by validated questionnaire (PDFI-20)

Secondary Outcome Measures

1. Pelvic floor muscle strength assessed by perineometry [9 months]

   measuring the pressure with vaginal manometry in cm H2O during pelvic floor contraction

2. Pelvic floor muscle strength assessed by electromyography [9 months]

   Assessed by vaginal surface electrode during pelvic floor contraction, measured in mV

3. Proportion of anatomical pelvic organ prolapse [9 months]

   Assessment with the Pelvic Organ Prolapse Quantification (POP-Q) System

4. Proportion of anatomical sphincter ani defect [9 months]

   Anatomical sphincter ani defect assessed by transperineal ultrasound

5. Proportion of levator ani muscle trauma [9 months]

   Assessed by transperineal ultrasound on contraction and Valsalva

6. Assessment of pelvic organ mobility as a measure of pelvic organ function/dysfunction [9 months]

   Movement of the pelvic organs during Valsalva and contraction

7. Imaging of synthetic implants assessed by ultrasound [9 months]

   Registration of implants after pelvic floor surgery and their relations to anatomical structures in mm.

8. Symptoms of pelvic floor disorders [9 months]

   Symptoms of pelvic floor disorders assessed by validated questionnaire (PFIQ-7)

9. Symptoms of pelvic floor disorders [9 months]

   Symptoms of pelvic floor disorders assessed by visual analogue scale (VAS 1-10)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	St Olavs Hospital	Trondheim		Norway

Sponsors and Collaborators

• St. Olavs Hospital
• Norwegian University of Science and Technology

Investigators

• Study Director: Kjell Å Salvesen, md prof, St Olavs Hospital University Hospital Trondheim

Study Documents (Full-Text)

None provided.

More Information

Publications

• Nyhus MØ, Oversand SH, Salvesen Ø, Salvesen KÅ, Mathew S, Volløyhaug 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.

• Responsible Party: St. Olavs Hospital
• ClinicalTrials.gov Identifier: NCT03064750
• Other Study ID Numbers: 2015/1751
• First Posted: Feb 27, 2017
• Last Update Posted: Dec 17, 2021
• Last Verified: Dec 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by St. Olavs Hospital: Exercise Therapy; Pelvic Floor; Preoperative Care
• Additional relevant MeSH terms: Pelvic Floor Disorders; Prolapse; Pelvic Organ Prolapse

Study Results

No Results Posted as of Dec 17, 2021