Perineorraphy Versus Pelvic Floor Exercise - a Randomized Trial
NCT ID: NCT02545218
Last Updated: 2018-08-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
70 participants
INTERVENTIONAL
2015-09-30
2019-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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.
Perineorraphy
Surgery for improperly healed perineal tear
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.
Pelvic floor exercise
Pelvic floor exercise tutored by physio therapist.
Interventions
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Perineorraphy
Surgery for improperly healed perineal tear
Pelvic floor exercise
Pelvic floor exercise tutored by physio therapist.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
FEMALE
No
Sponsors
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Stockholm South General Hospital
OTHER
Responsible Party
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Marion Ek
M.D. Ph.D.
Principal Investigators
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Marion Ek, M.D., Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Stockholm South General Hospital
Locations
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Södersjukhuset
Stockholm, , Sweden
Countries
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References
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Woodman PJ, Graney DO. Anatomy and physiology of the female perineal body with relevance to obstetrical injury and repair. Clin Anat. 2002 Aug;15(5):321-34. doi: 10.1002/ca.10034.
Harvey MA. Pelvic floor exercises during and after pregnancy: a systematic review of their role in preventing pelvic floor dysfunction. J Obstet Gynaecol Can. 2003 Jun;25(6):487-98. doi: 10.1016/s1701-2163(16)30310-3.
Bergman I, Westergren Soderberg M, Ek M. Perineorrhaphy Compared With Pelvic Floor Muscle Therapy in Women With Late Consequences of a Poorly Healed Second-Degree Perineal Tear: A Randomized Controlled Trial. Obstet Gynecol. 2020 Feb;135(2):341-351. doi: 10.1097/AOG.0000000000003653.
Other Identifiers
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StockholmSGH
Identifier Type: -
Identifier Source: org_study_id
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