Obstetric Perineal Trauma and Physiotherapy
Primary Purpose
Pregnancy Complications
Status
Completed
Phase
Not Applicable
Locations
Iceland
Study Type
Interventional
Intervention
Physiotherapy intervention
Sponsored by
About this trial
This is an interventional treatment trial for Pregnancy Complications focused on measuring Pelvic floor, obstetrics, perineal tear, physiotherapy
Eligibility 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.
Sites / Locations
- Tap, Physical Therapy Clinic
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Physiotherapy intervention
No intervention
Arm Description
Intensive pelvic floor muscle training (PFMT) given by a physiotherapist with vaginal/rectal pressure feedback once a week for 12 weeks.
Standard care
Outcomes
Primary Outcome Measures
Urinary incontinence rates measured by scores on the Australian Female PelvicFloor questionnaire
Urinary incontinence rates measured by scores on the Australian Female PelvicFloor questionnaire
Secondary Outcome Measures
Fecal/flatal incontinence measured by scores on the Australian Female PelvicFloor questionnaire
Fecal/flatal incontinence measured by scores on the Australian Female PelvicFloor questionnaire
Sexual dysfunction measured by scores on the Australian Female PelvicFloor questionnaire
Sexual dysfunction measured by scores on the Australian Female PelvicFloor questionnaire
Quality of life measured by scores on the Australian Female PelvicFloor questionnaire
Quality of life measured by scores on the Australian Female PelvicFloor questionnaire
Full Information
NCT ID
NCT02682212
First Posted
March 30, 2015
Last Updated
April 15, 2019
Sponsor
Landspitali University Hospital
Collaborators
University of Iceland
1. Study Identification
Unique Protocol Identification Number
NCT02682212
Brief Title
Obstetric Perineal Trauma and Physiotherapy
Official Title
Obstetric Perineal Trauma, Pelvic Floor Symptoms and Early Physiotherapy Intervention
Study Type
Interventional
2. Study Status
Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
March 16, 2016 (Actual)
Primary Completion Date
January 2018 (Actual)
Study Completion Date
January 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Landspitali University Hospital
Collaborators
University of Iceland
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pregnancy Complications
Keywords
Pelvic floor, obstetrics, perineal tear, physiotherapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
84 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Physiotherapy intervention
Arm Type
Experimental
Arm Description
Intensive pelvic floor muscle training (PFMT) given by a physiotherapist with vaginal/rectal pressure feedback once a week for 12 weeks.
Arm Title
No intervention
Arm Type
No Intervention
Arm Description
Standard care
Intervention Type
Other
Intervention Name(s)
Physiotherapy intervention
Intervention Description
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.
Primary Outcome Measure Information:
Title
Urinary incontinence rates measured by scores on the Australian Female PelvicFloor questionnaire
Description
Urinary incontinence rates measured by scores on the Australian Female PelvicFloor questionnaire
Time Frame
16 weeks
Secondary Outcome Measure Information:
Title
Fecal/flatal incontinence measured by scores on the Australian Female PelvicFloor questionnaire
Description
Fecal/flatal incontinence measured by scores on the Australian Female PelvicFloor questionnaire
Time Frame
16 weeks
Title
Sexual dysfunction measured by scores on the Australian Female PelvicFloor questionnaire
Description
Sexual dysfunction measured by scores on the Australian Female PelvicFloor questionnaire
Time Frame
16 weeks
Title
Quality of life measured by scores on the Australian Female PelvicFloor questionnaire
Description
Quality of life measured by scores on the Australian Female PelvicFloor questionnaire
Time Frame
16 weeks
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thora Steingrimsdottir, MD, PhD
Organizational Affiliation
Landspitali University Hospital/University of Iceland, Reykjavik, Iceland
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Kari Bo, PhD
Organizational Affiliation
Norwegian School of Sports Sciences, Oslo, Norway
Official's Role
Study Chair
Facility Information:
Facility Name
Tap, Physical Therapy Clinic
City
Kopavogur
ZIP/Postal Code
201
Country
Iceland
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
32378735
Citation
Woodley SJ, Lawrenson P, Boyle R, Cody JD, Morkved S, Kernohan A, Hay-Smith EJC. Pelvic floor muscle training for preventing and treating urinary and faecal incontinence in antenatal and postnatal women. Cochrane Database Syst Rev. 2020 May 6;5(5):CD007471. doi: 10.1002/14651858.CD007471.pub4.
Results Reference
derived
PubMed Identifier
31526791
Citation
Sigurdardottir T, Steingrimsdottir T, Geirsson RT, Halldorsson TI, Aspelund T, Bo K. Can postpartum pelvic floor muscle training reduce urinary and anal incontinence?: An assessor-blinded randomized controlled trial. Am J Obstet Gynecol. 2020 Mar;222(3):247.e1-247.e8. doi: 10.1016/j.ajog.2019.09.011. Epub 2019 Sep 14.
Results Reference
derived
Learn more about this trial
Obstetric Perineal Trauma and Physiotherapy
We'll reach out to this number within 24 hrs