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Completed

NCT Number: NCT03064750

Pelvic Floor Exercise Before Surgery in Women With Pelvic Organ Prolapse

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.

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Key information

Conditions

Pelvic Organ Prolapse Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Male Urogenital Diseases Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Pelvic Floor Disorders Pregnancy Complications Prolapse Urogenital Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

St Olavs Hospital

Trondheim, Norway

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Waiting List

Other

patients wait as usual until surgery without special treatment.

Primary outcomes

  1. Pelvic floor muscle strength assessed by palpation

    Time frame: 9 months

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

  2. Pelvic floor muscle strength assessed by ultrasound

    Time frame: 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

    Time frame: 9 months

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

Secondary outcomes

  1. Pelvic floor muscle strength assessed by perineometry

    Time frame: 9 months

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

  2. Pelvic floor muscle strength assessed by electromyography

    Time frame: 9 months

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

  3. Proportion of anatomical pelvic organ prolapse

    Time frame: 9 months

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

  4. Proportion of anatomical sphincter ani defect

    Time frame: 9 months

    Anatomical sphincter ani defect assessed by transperineal ultrasound

  5. Proportion of levator ani muscle trauma

    Time frame: 9 months

    Assessed by transperineal ultrasound on contraction and Valsalva

  6. Assessment of pelvic organ mobility as a measure of pelvic organ function/dysfunction

    Time frame: 9 months

    Movement of the pelvic organs during Valsalva and contraction

  7. Imaging of synthetic implants assessed by ultrasound

    Time frame: 9 months

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

  8. Symptoms of pelvic floor disorders

    Time frame: 9 months

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

  9. Symptoms of pelvic floor disorders

    Time frame: 9 months

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

Sponsors and collaborators

Lead sponsor

St. Olavs Hospital

Other

Collaborators

  • Norwegian University of Science and Technology

Registry information

Acronym: CONTRAPOP

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Feb 27, 2017
Registry last updated
Dec 17, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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