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Perineorraphy Versus Pelvic Floor Exercise - a Randomized Trial

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02545218
Recruitment Status : Unknown
Verified August 2018 by Marion Ek, Stockholm South General Hospital.
Recruitment status was:  Active, not recruiting
First Posted : September 9, 2015
Last Update Posted : August 24, 2018
Sponsor:
Information provided by (Responsible Party):
Marion Ek, 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.

Condition or disease Intervention/treatment Phase
Perineal Tear Resulting From Childbirth Procedure: Perineorraphy Other: Pelvic floor exercise Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Perineorraphy Versus Pelvic Floor Exercise - a Randomized Trial
Actual Study Start Date : September 2015
Actual Primary Completion Date : June 2018
Estimated Study Completion Date : June 2019

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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.

  2. 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

  3. 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

  4. 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.

  5. Prolapse Incontinence Sexual Questionnaire (PISQ) [ Time Frame: 6 months after intervention (operation or start of pelvic floor training) ]
    Evaluate effects on sexual functions

  6. Hospital Anxiety and Depression Scale (HAD) [ Time Frame: 6 months after intervention (operation or start of pelvic floor training) ]
    Evaluate psychological effects

  7. 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.

  8. Surgical complications [ Time Frame: From surgery up to 6 months postoperatively ]
    Infections.Bleedings. Other complications.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02545218


Locations
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Sweden
Södersjukhuset
Stockholm, Sweden, 11861
Sponsors and Collaborators
Stockholm South General Hospital
Investigators
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Principal Investigator: Marion Ek, M.D., Ph.D. Stockholm South General Hospital
Publications of Results:
Other Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Marion Ek, M.D. Ph.D., Stockholm South General Hospital
ClinicalTrials.gov Identifier: NCT02545218    
Other Study ID Numbers: StockholmSGH
First Posted: September 9, 2015    Key Record Dates
Last Update Posted: August 24, 2018
Last Verified: August 2018
Keywords provided by Marion Ek, Stockholm South General Hospital:
Perineum. Perineorraphy. Pelvic floor exercise.