Perineorraphy Versus Pelvic Floor Exercise - a Randomized Trial

August 22, 2018 updated by: Marion Ek, Stockholm South General Hospital
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.

Study Overview

Status

Unknown

Conditions

Intervention / 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 Type

Interventional

Enrollment (Actual)

70

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Stockholm, Sweden, 11861
        • Sodersjukhuset

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient Global Impression of Improvement (PGI-1)
Time Frame: 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
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)
Time Frame: 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.
6 months after intervention (operation or start of pelvic floor training)
Ultrasound of perineum
Time Frame: 6 months after intervention (operation or start of pelvic floor training)
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)
Time Frame: 6 months after intervention (operation or start of pelvic floor training)
20 validated questions concerning prolapse related symptoms
6 months after intervention (operation or start of pelvic floor training)
Pelvic Floor Impact Questionnaire (PIFQ-7)
Time Frame: 6 months after intervention (operation or start of pelvic floor training)
Evaluates the effect on quality of lafe.
6 months after intervention (operation or start of pelvic floor training)
Prolapse Incontinence Sexual Questionnaire (PISQ)
Time Frame: 6 months after intervention (operation or start of pelvic floor training)
Evaluate effects on sexual functions
6 months after intervention (operation or start of pelvic floor training)
Hospital Anxiety and Depression Scale (HAD)
Time Frame: 6 months after intervention (operation or start of pelvic floor training)
Evaluate psychological effects
6 months after intervention (operation or start of pelvic floor training)
Vaginal symptoms
Time Frame: 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.
6 months after intervention (operation or start of pelvic floor training)
Surgical complications
Time Frame: From surgery up to 6 months postoperatively
Infections.Bleedings. Other complications.
From surgery up to 6 months postoperatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Stockholm South General Hospital

Investigators

  • Principal Investigator: Marion Ek, M.D., Ph.D., Stockholm South General Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2015

Primary Completion (Actual)

June 1, 2018

Study Completion (Anticipated)

June 1, 2019

Study Registration Dates

First Submitted

September 7, 2015

First Submitted That Met QC Criteria

September 7, 2015

First Posted (Estimate)

September 9, 2015

Study Record Updates

Last Update Posted (Actual)

August 24, 2018

Last Update Submitted That Met QC Criteria

August 22, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • StockholmSGH

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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