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Trial record 48 of 217 for:    strength | Norway

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

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ClinicalTrials.gov Identifier: NCT03064750
Recruitment Status : Completed
First Posted : February 27, 2017
Last Update Posted : August 14, 2019
Sponsor:
Collaborator:
Norwegian University of Science and Technology
Information provided by (Responsible Party):
St. Olavs Hospital

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 Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 330 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 : January 1, 2017
Actual Primary Completion Date : June 26, 2019
Actual Study Completion Date : June 26, 2019

Resource links provided by the National Library of Medicine


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.

Waiting list
wait as usual until surgery
Other: Waiting list
patients wait as usual until surgery without special treatment.




Primary Outcome Measures :
  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 Outcome Measures :
  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)



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03064750


Locations
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Norway
St Olavs Hospital
Trondheim, Norway
Sponsors and Collaborators
St. Olavs Hospital
Norwegian University of Science and Technology
Investigators
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Study Director: Kjell Å Salvesen, md prof St Olavs Hospital University Hospital Trondheim

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Responsible Party: St. Olavs Hospital
ClinicalTrials.gov Identifier: NCT03064750     History of Changes
Other Study ID Numbers: 2015/1751
First Posted: February 27, 2017    Key Record Dates
Last Update Posted: August 14, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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:
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Pelvic Floor Disorders
Prolapse
Pelvic Organ Prolapse
Pathological Conditions, Anatomical
Pregnancy Complications