Perineorraphy Versus Pelvic Floor Exercise - a Randomized Trial

Not Applicable

• Conditions: Perineal Tear Resulting From Childbirth
• Interventions: Procedure: Perineorraphy; Other: Pelvic floor exercise

• Registration Number: NCT02545218
• Lead Sponsor: Stockholm South General Hospital

Brief 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.

Study Timeline

• Study Start: 2015-09
• Study First Submitted: 2015-09-07
• Study First Submitted QC: 2015-09-07
• Study First Posted: 2015-09-09
• Primary Completion: 2018-06
• Status Verified: 2018-08
• Last Update Submitted: 2018-08-22
• Last Update Posted: 2018-08-24
• Study Completion: 2019-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 70

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Perineorraphy.	Perineorraphy	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.
Pelvic floor exercise.	Pelvic floor exercise	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.

Primary Outcome Measures

Name	Time	Method
Patient Global Impression of Improvement (PGI-1)	6 months after intervention (operation or start of pelvic floor training)	Patients own assessment of improvement 6 months after intervention using a seven grade assessment tool called PGI-1

Secondary Outcome Measures

Name	Time	Method
Ultrasound of perineum	6 months after intervention (operation or start of pelvic floor training)	Height and depth of perineum i millimeters using ultrasonography
Hospital Anxiety and Depression Scale (HAD)	6 months after intervention (operation or start of pelvic floor training)	Evaluate psychological effects
Pelvic Floor Impact Questionnaire (PIFQ-7)	6 months after intervention (operation or start of pelvic floor training)	Evaluates the effect on quality of lafe.
Vaginal symptoms	6 months after intervention (operation or start of pelvic floor training)	Three non-validated questions concerning vaginal symptoms; sensation of wideness, vaginal flatulence and excessive discharge.
Surgical complications	From surgery up to 6 months postoperatively	Infections.Bleedings. Other complications.
Prolapse Incontinence Sexual Questionnaire (PISQ)	6 months after intervention (operation or start of pelvic floor training)	Evaluate effects on sexual functions
POP-Q (Pelvic organ Quantification System)	6 months after intervention (operation or start of pelvic floor training)	Pelvic organ prolapse is graded via the Pelvic organ Quantification System (POP-Q) into stage 0-4. It is a validated way to clinically assess and stage of the female pelvic floor.
Pelvic floor distress inventory (PFDI 20)	6 months after intervention (operation or start of pelvic floor training)	20 validated questions concerning prolapse related symptoms

Trial Locations

Locations (1)

Södersjukhuset; 🇸🇪 Stockholm, Sweden