NCT02545218

Perineorraphy Versus Pelvic Floor Exercise - a Randomized Trial

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 70 (actual)
• Sponsor: Stockholm South General Hospital · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The perineal body is commonly injured during labor. It is possible to perform a secondary repair, a perineorraphy, which aims to reduce the symptomatology after an improperly healed perineal tear. The aim of the randomized trial is to evaluate the results of such an operation compared with conservative treatment.

Detailed description

A randomized controlled trial which aims to evaluate objective and subjective outcomes following perineorraphy compared with pelvic floor exercise after vaginal delivery. 70 women seeking help for improperly healed perineal tear following vaginal delivery, matching our inclusion- and exclusion criteria, will be randomised into two different treatment groups, 35 to operative treatment, perineorraphy, and 35 to conservative treatment, tutored pelvic floor exercise. Assessment pre-and 6 months postoperatively will include clinical evaluation and condition specific validated questionnaires. Surgical characteristics and adverse events during follow-up are also registered.

Conditions

• Perineal Tear Resulting From Childbirth

Interventions

Type	Name	Description
PROCEDURE	Perineorraphy	Surgery for improperly healed perineal tear
OTHER	Pelvic floor exercise	Pelvic floor exercise tutored by physio therapist.

Timeline

• Start date: 2015-09-01
• Primary completion: 2018-06-01
• Completion: 2019-06-01
• First posted: 2015-09-09
• Last updated: 2018-08-24

Locations

1 site across 1 country: Sweden