Clinical trial NCT03064750: Pelvic Floor Exercise Before Surgery in Women With Pelvic Organ Prolapse
Official title: Pelvic Floor Exercise Before Surgery in Women With Pelvic Organ Prolapse
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pelvic Organ Prolapse
Pelvic Floor Disorders
Keywords: Exercise Therapy
Pelvic Floor
Preoperative Care
Lead sponsor: St. Olavs Hospital
Sponsor class: OTHER
Collaborators: name: Norwegian University of Science and Technology
First posted: 2017-02-27
Enrollment: 151
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Pelvic floor muscle strength assessed by palpation
timeFrame: 9 months
measure: Pelvic floor muscle strength assessed by ultrasound
timeFrame: 9 months
measure: Symptoms of pelvic floor disorders
timeFrame: 9 months
Secondary outcomes:
measure: Pelvic floor muscle strength assessed by perineometry
timeFrame: 9 months
measure: Pelvic floor muscle strength assessed by electromyography
timeFrame: 9 months
measure: Proportion of anatomical pelvic organ prolapse
timeFrame: 9 months
measure: Proportion of anatomical sphincter ani defect
timeFrame: 9 months
measure: Proportion of levator ani muscle trauma
timeFrame: 9 months
measure: Assessment of pelvic organ mobility as a measure of pelvic organ function/dysfunction
timeFrame: 9 months
measure: Imaging of synthetic implants assessed by ultrasound
timeFrame: 9 months
measure: Symptoms of pelvic floor disorders
timeFrame: 9 months
measure: Symptoms of pelvic floor disorders
timeFrame: 9 months
Other outcomes:
Locations:
city: Trondheim
country: Norway
facility: St Olavs Hospital
Study officials:
affiliation: St Olavs Hospital University Hospital Trondheim
name: Kjell Å Salvesen, md prof
role: STUDY_DIRECTOR
References:
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.
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.
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.