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Perineorraphy Versus Pelvic Floor Exercise - a Randomized Trial

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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

Tracking Information
First Submitted Date  ICMJE September 7, 2015
First Posted Date  ICMJE September 9, 2015
Last Update Posted Date August 24, 2018
Actual Study Start Date  ICMJE September 2015
Actual Primary Completion Date June 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 7, 2015)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 10, 2015)
  • 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.
  • 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
  • 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
  • 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.
  • Prolapse Incontinence Sexual Questionnaire (PISQ) [ Time Frame: 6 months after intervention (operation or start of pelvic floor training) ]
    Evaluate effects on sexual functions
  • Hospital Anxiety and Depression Scale (HAD) [ Time Frame: 6 months after intervention (operation or start of pelvic floor training) ]
    Evaluate psychological effects
  • 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.
  • Surgical complications [ Time Frame: From surgery up to 6 months postoperatively ]
    Infections.Bleedings. Other complications.
Original Secondary Outcome Measures  ICMJE
 (submitted: September 7, 2015)
  • POP-Q [ Time Frame: 6 months after intervention (operation or start of pelvic floor training) ]
    Validated clinical assessment of the female pelvic floor
  • 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
  • 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
  • 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.
  • Prolapse Incontinence Sexual Questionnaire (PISQ) [ Time Frame: 6 months after intervention (operation or start of pelvic floor training) ]
    Evaluate effects on sexual functions
  • Hospital Anxiety and Depression Scale (HAD) [ Time Frame: 6 months after intervention (operation or start of pelvic floor training) ]
    Evaluate psychological effects
  • 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.
  • Surgical complications [ Time Frame: From surgery up to 6 months postoperatively ]
    Infections.Bleedings. Other complications.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Perineorraphy Versus Pelvic Floor Exercise - a Randomized Trial
Official Title  ICMJE Perineorraphy Versus Pelvic Floor Exercise - a Randomized Trial
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Perineal Tear Resulting From Childbirth
Intervention  ICMJE
  • Procedure: Perineorraphy
    Surgery for improperly healed perineal tear
  • Other: Pelvic floor exercise
    Pelvic floor exercise tutored by physio therapist.
Study Arms  ICMJE
  • 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.
    Intervention: Procedure: Perineorraphy
  • 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.
    Intervention: Other: Pelvic floor exercise
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Actual Enrollment  ICMJE
 (submitted: September 7, 2015)
70
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 2019
Actual Primary Completion Date June 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Sweden
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02545218
Other Study ID Numbers  ICMJE StockholmSGH
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Marion Ek, Stockholm South General Hospital
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Stockholm South General Hospital
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Marion Ek, M.D., Ph.D. Stockholm South General Hospital
PRS Account Stockholm South General Hospital
Verification Date August 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP