Pelvic Floor Exercise Before Surgery in Women With Pelvic Organ Prolapse

NCT03064750 | Completed

• 1 other identifier: 2015/1751
• Study Type: interventional
• Target: 151
• Locations: 1 country
• Sites: 1

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.

Conditions

Pelvic Organ Prolapse; Pelvic Floor Disorders

Keywords

Exercise Therapy; Pelvic Floor; Preoperative Care

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (9)

• Pelvic floor muscle strength assessed by perineometry

  9 months

• Pelvic floor muscle strength assessed by electromyography

  9 months

• Proportion of anatomical pelvic organ prolapse

  9 months

• Proportion of anatomical sphincter ani defect

  9 months

• Proportion of levator ani muscle trauma

  9 months

Study Arms (2)

Pre-surgery exercise

EXPERIMENTAL

pelvic floor exercises individually and in groups

Behavioral: pelvic floor exercises

Waiting list

OTHER

wait as usual until surgery

Other: Waiting list

Interventions

pelvic floor exercises BEHAVIORAL

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.

Pre-surgery exercise

Waiting list OTHER

patients wait as usual until surgery without special treatment.

Waiting list

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• referred to surgery for urogenital prolapse
• informed consent

You may not qualify if:

• not able to communicate in Norwegian or English
• not able or willing to sign informed consent

Sponsors & Collaborators

• St. Olavs Hospital: lead
• Norwegian University of Science and Technology: collaborator

Study Sites (1)

St Olavs Hospital

Trondheim, Norway

Location

Related Publications (3)

• 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.

  PMID: 31237722 BACKGROUND

• 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.

  PMID: 32144829 RESULT

• 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.

  PMID: 33580809 RESULT

MeSH Terms

Conditions

Pelvic Organ Prolapse; Pelvic Floor Disorders

Interventions

Waiting Lists

Condition Hierarchy (Ancestors)

Prolapse; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Pregnancy Complications; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Appointments and Schedules; Organization and Administration; Health Services Administration

Study Officials

• Kjell Å Salvesen, md prof

  St Olavs Hospital University Hospital Trondheim

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 22, 2017
• First Posted: February 27, 2017
• Study Start: January 1, 2017
• Primary Completion: June 26, 2019
• Study Completion: June 26, 2019
• Last Updated: December 17, 2021

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

NO (1)