Pelvic Floor Exercise Before Surgery in Women With Pelvic Organ Prolapse

Pelvic Organ Prolapse Clinical Trial

— CONTRAPOP  

Official title:

Pelvic Floor Exercise Before Surgery in Women With Pelvic Organ Prolapse

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03064750
• Other study ID #: 2015/1751
• Status: Completed
• Phase: N/A
• Start date: January 1, 2017
• Est. completion date: June 26, 2019

Study information

• Verified date: December 2021
• Source: St. Olavs Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 151
• Est. completion date: June 26, 2019
• Est. primary completion date: June 26, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pelvic Floor Disorders
• Pelvic Organ Prolapse
• Prolapse

Intervention

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
patients wait as usual until surgery without special treatment.

Locations

Country	Name	City	State
Norway	St Olavs Hospital	Trondheim

Sponsors (2)

Lead Sponsor	Collaborator
St. Olavs Hospital	Norwegian University of Science and Technology

Country where clinical trial is conducted

Norway, 

References & Publications (3)

Mathew S, Nyhus MØ, Salvesen Ø, Salvesen KÅ, Stafne SN, Volløyhaug 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 Urog — View Citation

Nyhus MØ, Mathew S, Salvesen Ø, Salvesen KÅ, Stafne S, Volløyhaug 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. Ul — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pelvic floor muscle strength assessed by palpation	Muscle strength is evaluated using 6 point modified Oxford Scale (MOS) range 0-5.	9 months
Primary	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
Primary	Symptoms of pelvic floor disorders	Symptoms of pelvic floor disorders assessed by validated questionnaire (PDFI-20)	9 months
Secondary	Pelvic floor muscle strength assessed by perineometry	measuring the pressure with vaginal manometry in cm H2O during pelvic floor contraction	9 months
Secondary	Pelvic floor muscle strength assessed by electromyography	Assessed by vaginal surface electrode during pelvic floor contraction, measured in mV	9 months
Secondary	Proportion of anatomical pelvic organ prolapse	Assessment with the Pelvic Organ Prolapse Quantification (POP-Q) System	9 months
Secondary	Proportion of anatomical sphincter ani defect	Anatomical sphincter ani defect assessed by transperineal ultrasound	9 months
Secondary	Proportion of levator ani muscle trauma	Assessed by transperineal ultrasound on contraction and Valsalva	9 months
Secondary	Assessment of pelvic organ mobility as a measure of pelvic organ function/dysfunction	Movement of the pelvic organs during Valsalva and contraction	9 months
Secondary	Imaging of synthetic implants assessed by ultrasound	Registration of implants after pelvic floor surgery and their relations to anatomical structures in mm.	9 months
Secondary	Symptoms of pelvic floor disorders	Symptoms of pelvic floor disorders assessed by validated questionnaire (PFIQ-7)	9 months
Secondary	Symptoms of pelvic floor disorders	Symptoms of pelvic floor disorders assessed by visual analogue scale (VAS 1-10)	9 months