Perineorraphy Versus Pelvic Floor Exercise - a Randomized Trial

Study Overview
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Brief Summary
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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
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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.

Official Title
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Perineorraphy Versus Pelvic Floor Exercise - a Randomized Trial

Conditions
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Perineal Tear Resulting From Childbirth

Intervention / Treatment
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* Procedure: Perineorraphy
* Other: Pelvic floor exercise


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Perineorraphy.<br>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. | Procedure: Perineorraphy<br>* Surgery for improperly healed perineal tear<br>|
| Active Comparator: Pelvic floor exercise.<br>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. | Other: Pelvic floor exercise<br>* Pelvic floor exercise tutored by physio therapist.<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Perineum. Perineorraphy. Pelvic floor exercise.