Perineorraphy Versus Pelvic Floor Exercise - a Randomized Trial

Stockholm South General Hospital

Status: Unknown

Conditions: Perineal Tear Resulting From Childbirth

Treatments: Other: Pelvic floor exercise; Procedure: Perineorraphy

Study type: Interventional

Funder types: Other

Identifiers

NCT02545218

StockholmSGH

Details and patient eligibility

About

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.

Full 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.

Enrollment: 70 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• women with 2nd or 3rd degree laceration during vaginal delivery seeking for help because of troublesome symptoms from the pelvic floor
• height of perineum 2 cm or less.
• A least 6 months post partum
• stopped "exclusive breastfeeding"
• no indication for other gynecological surgical procedure

Exclusion criteria

• history of 4th degree laceration
• connective tissue disorder (Systemic lupus erythematosus, Sjögrens syndrome, Polymyalgia rheumatica, Marfans syndrome, Ehlers-Danlos syndrome)
• current use of systemic corticosteroids
• diabetes mellitus
• suspect occult sphincter tear on ultrasound
• history of previous urogynecological operation

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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70 participants in 2 patient groups

Perineorraphy.

Active Comparator group

Description:

Secondary surgical repair of the perineal body. Operation is performed by a urogynecologist in an operation theater in local anesthesia. The operation aims to re-create the anatomy in the injured perineum using 2-4 sutures.

Treatment:

Procedure: Perineorraphy

Pelvic floor exercise.

Active Comparator group

Description:

Tutored pelvic floor exercise. A trained physio therapist evaluate the pelvic floor musculature and helps the patient to perform proper pelvic floor exercises using biofeedback. The patient receives a training scheme and meets the therapist regularly every second week during 4 months.

Treatment:

Other: Pelvic floor exercise