- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02682212
Obstetric Perineal Trauma and Physiotherapy
Obstetric Perineal Trauma, Pelvic Floor Symptoms and Early Physiotherapy Intervention
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.
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Kopavogur, Iceland, 201
- Tap, Physical Therapy Clinic
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: No intervention
Standard care
|
|
Experimental: Physiotherapy intervention
Intensive pelvic floor muscle training (PFMT) given by a physiotherapist with vaginal/rectal pressure feedback once a week for 12 weeks.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
16 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
16 weeks
|
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
|
16 weeks
|
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
|
16 weeks
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- 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 and helpful links
General Publications
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- LSH-15-001
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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.
Clinical Trials on Pregnancy Complications
-
The Cooper Health SystemRecruitingPregnancy,Neoplastic ComplicationsUnited States
-
Northwestern UniversityTerminatedPregnancy Related | Labor ComplicationUnited States
-
The George Washington University Biostatistics...Eunice Kennedy Shriver National Institute of Child Health and Human Development...Terminated
-
Jazz PharmaceuticalsRecruitingPregnancy | Pregnancy Complication | Maternal Complications | Birth Outcomes, AdverseUnited States
-
Oslo University HospitalRecruitingPregnancy Related | Labor Complication | Induced; BirthNorway
-
Thomas Jefferson UniversityCompleted
-
Washington University School of MedicineUniversity of MichiganRecruiting
-
Egas Moniz - Cooperativa de Ensino Superior, CRLCompleted
-
University Hospital Center of MartiniqueCompletedLabor Complication | CervixMartinique
-
PerspectumUniversity of Oxford; Fetal Medicine FoundationCompletedPregnancy Complications | Fetal Growth ComplicationsUnited Kingdom
Clinical Trials on Physiotherapy intervention
-
Universidade Nova de LisboaUnknown
-
Universidade Nova de LisboaUnknownChronic Nonspecific Neck Pain
-
University Hospitals of Derby and Burton NHS Foundation...Not yet recruiting
-
University of the Sinos ValleyCompletedDeafness | Motor Skills in Deaf ChildrenBrazil
-
Landspitali University HospitalUniversity of IcelandUnknownPelvic Organ ProlapseIceland
-
University of ValenciaUnknownGeriatric DisorderSpain
-
Asir John SamuelCompletedAbdominal SurgeryIndia
-
National Taiwan University HospitalNational Science Council, TaiwanUnknown
-
University Hospital of North NorwayOslo University Hospital; University of Tromso; University of Illinois at Chicago and other collaboratorsCompleted
-
Nigde Omer Halisdemir UniversityCompleted