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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT02682212 |
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Date of registration:
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30/03/2015 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Obstetric Perineal Trauma and Physiotherapy
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Scientific title:
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Obstetric Perineal Trauma, Pelvic Floor Symptoms and Early Physiotherapy Intervention |
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Date of first enrolment:
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March 16, 2016 |
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Target sample size:
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84 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02682212 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Single (Outcomes Assessor).
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Phase:
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N/A
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Countries of recruitment
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Iceland
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Contacts
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Name:
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Thora Steingrimsdottir, MD, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Landspitali University Hospital/University of Iceland, Reykjavik, Iceland |
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Name:
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Kari Bo, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Norwegian School of Sports Sciences, Oslo, Norway |
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Key inclusion & exclusion criteria
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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.
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Pregnancy Complications
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Intervention(s)
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Other: Physiotherapy intervention
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Primary Outcome(s)
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Urinary incontinence rates measured by scores on the Australian Female PelvicFloor questionnaire
[Time Frame: 16 weeks]
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Secondary Outcome(s)
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Sexual dysfunction measured by scores on the Australian Female PelvicFloor questionnaire
[Time Frame: 16 weeks]
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Fecal/flatal incontinence measured by scores on the Australian Female PelvicFloor questionnaire
[Time Frame: 16 weeks]
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Quality of life measured by scores on the Australian Female PelvicFloor questionnaire
[Time Frame: 16 weeks]
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Secondary ID(s)
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LSH-15-001
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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