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Obstetric Perineal Trauma and Physiotherapy

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: NCT02682212
Recruitment Status : Completed
First Posted : February 15, 2016
Last Update Posted : April 16, 2019
Sponsor:
Collaborator:
University of Iceland
Information provided by (Responsible Party):
Landspitali University Hospital

Brief Summary:

The main objective is to investigate effects of perineal trauma at birth on women´s health and whether early physiotherapy improves pelvic floor strength. This will be achieved by an acknowledged/validated questionnaire sent electronically 6 weeks after first delivery. Women with symptomes of urinary incontinence according to the questionnaire will be offered participation in a single-blinded randomized intervention study to compare outcome after targeted physiotherapy with conventional advice and support. Intervention encompasses weekly pelvic floor training for 12 weeks. Pelvic strength will be measured and symptom information collected before and after intervention and 12 months postpartum in both groups.

Pelvic floor problems after delivery are common and often persistent, including urinary/fecal incontinence, pelvic organ prolapse and sexual problems. Such symptoms reduce QoL and handicap women in multiple ways, physically, psychologically and socially. More knowledge of whether interventions and guidelines in this field can improve health and QoL is required.


Condition or disease Intervention/treatment Phase
Pregnancy Complications Other: Physiotherapy intervention Not Applicable

Detailed Description:

Single-blind randomized controlled trial (RCT) to assess and compare the effects of early pelvic floor muscle training and present standard care/advice on pelvic floor muscle (PFM) strength, symptoms from the pelvic floor and bothersome symptoms (QoL) after obstetric perineal repair.

Procedure/Study design: Single-blind randomized controlled trial.

Details of test administration and data collection methods:

PFM strength will be measured with Myomed 932® (Enraf-Nonius, Delft, Netherlands) for squeeze pressure, vaginally and rectally.

Pelvic floor symptoms, (bladder/bowel function, prolapse symptoms, sexual function) and bothersomeness will be measured with the validated Icelandic version of the Australian Female Pelvic Floor Questionnaire.

Assessment and treatment will begin from 6th week postpartum. After initial assessment, instruction on pelvic floor function the pelvic floor questionnaire administration, participants will be randomized to intervention and control groups by a person not involved in measurements or treatment. The intervention group will receive individual treatment by a physiotherapist not involved in the initial assesment. This will be in the form of intensive PFMT with vaginal/rectal pressure feedback once a week for 12 weeks and be encouraged to do daily exercises. Repeated assessment of pelvic floor function and questionnaire administration will be after 12 weeks for both groups and repeated 12 months after birth.

Assessment of pelvic floor function includes rectal/vaginal resting pressure, PFM strength (maximal voluntary contraction, strongest of three measured as a vaginal and anal squeeze pressure), and endurance for 10 sec (area under the curve both rectal and vaginal).

Preliminary assumption of power (beta) of 80% and a level of significance (alfa) of 5% and estimating 1 against 3 women with symptoms of urinary incontinence in treatment vs. control groups, respectively after intervention, ca. 40 women will be needed per group.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 84 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Obstetric Perineal Trauma, Pelvic Floor Symptoms and Early Physiotherapy Intervention
Actual Study Start Date : March 16, 2016
Actual Primary Completion Date : January 2018
Actual Study Completion Date : January 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Physiotherapy intervention
Intensive pelvic floor muscle training (PFMT) given by a physiotherapist with vaginal/rectal pressure feedback once a week for 12 weeks.
Other: Physiotherapy intervention
Compare the effect of early physiotherapy intervention (pelvic floor muscle training, PFMT) with standard care on pelvic floor dysfunction symptoms, quality of life (QoL) and (pelvic floor muscle (PFM) strength, for women who answered the questionnaire positively for 1) urinary incontinence, 2) other dysfunction of the pelvic floor.

No Intervention: No intervention
Standard care



Primary Outcome Measures :
  1. Urinary incontinence rates measured by scores on the Australian Female PelvicFloor questionnaire [ Time Frame: 16 weeks ]
    Urinary incontinence rates measured by scores on the Australian Female PelvicFloor questionnaire


Secondary Outcome Measures :
  1. Fecal/flatal incontinence measured by scores on the Australian Female PelvicFloor questionnaire [ Time Frame: 16 weeks ]
    Fecal/flatal incontinence measured by scores on the Australian Female PelvicFloor questionnaire

  2. Sexual dysfunction measured by scores on the Australian Female PelvicFloor questionnaire [ Time Frame: 16 weeks ]
    Sexual dysfunction measured by scores on the Australian Female PelvicFloor questionnaire

  3. Quality of life measured by scores on the Australian Female PelvicFloor questionnaire [ Time Frame: 16 weeks ]
    Quality of life measured by scores on the Australian Female PelvicFloor questionnaire



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:

  • Healthy primiparas after delivery at LSH
  • ≥18 years
  • Diagnosed with urinary incontinence according to the self administered Australian Pelvic floor Questionnaire (Icelandic version) 6 weeks post partum.
  • Able to attend intervention in the capital area
  • Answer the Australian Pelvic Floor Questionnaire

Exclusion Criteria:

  • Diseases or conditions that can interfere with pelvic floor function (other than childbirth), such as prior pelvic floor surgery or ability to benefit from the intervention
  • Women unable to understand Icelandic
  • Woman with cognitive disabilities.

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): NCT02682212


Locations
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Iceland
Tap, Physical Therapy Clinic
Kopavogur, Iceland, 201
Sponsors and Collaborators
Landspitali University Hospital
University of Iceland
Investigators
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Principal Investigator: Thora Steingrimsdottir, MD, PhD Landspitali University Hospital/University of Iceland, Reykjavik, Iceland
Study Chair: Kari Bo, PhD Norwegian School of Sports Sciences, Oslo, Norway
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Landspitali University Hospital
ClinicalTrials.gov Identifier: NCT02682212    
Other Study ID Numbers: LSH-15-001
First Posted: February 15, 2016    Key Record Dates
Last Update Posted: April 16, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Landspitali University Hospital:
Pelvic floor
obstetrics
perineal tear
physiotherapy
Additional relevant MeSH terms:
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Pregnancy Complications