Clinical trial NCT02545218: Perineorraphy Versus Pelvic Floor Exercise - a Randomized Trial
Official title: Perineorraphy Versus Pelvic Floor Exercise - a Randomized Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Perineal Tear Resulting From Childbirth
Keywords: Perineum. Perineorraphy. Pelvic floor exercise.
Lead sponsor: Stockholm South General Hospital
Sponsor class: OTHER
First posted: 2015-09-09
Enrollment: 70
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The perineal body is commonly injured during labor. It is possible to perform a secondary repair, a perineorraphy, which aims to reduce the symptomatology after an improperly healed perineal tear. The aim of the randomized trial is to evaluate the results of such an operation compared with conservative treatment.

Detailed description: A randomized controlled trial which aims to evaluate objective and subjective outcomes following perineorraphy compared with pelvic floor exercise after vaginal delivery. 70 women seeking help for improperly healed perineal tear following vaginal delivery, matching our inclusion- and exclusion criteria, will be randomised into two different treatment groups, 35 to operative treatment, perineorraphy, and 35 to conservative treatment, tutored pelvic floor exercise. Assessment pre-and 6 months postoperatively will include clinical evaluation and condition specific validated questionnaires. Surgical characteristics and adverse events during follow-up are also registered.

Eligibility criteria: Inclusion Criteria:

* women with 2nd or 3rd degree laceration during vaginal delivery seeking for help because of troublesome symptoms from the pelvic floor
* 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:

* history of 4th degree laceration
* 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

Primary outcomes:
measure: Patient Global Impression of Improvement (PGI-1)
timeFrame: 6 months after intervention (operation or start of pelvic floor training)
Secondary outcomes:
measure: POP-Q (Pelvic organ Quantification System)
timeFrame: 6 months after intervention (operation or start of pelvic floor training)
measure: Ultrasound of perineum
timeFrame: 6 months after intervention (operation or start of pelvic floor training)
measure: Pelvic floor distress inventory (PFDI 20)
timeFrame: 6 months after intervention (operation or start of pelvic floor training)
measure: Pelvic Floor Impact Questionnaire (PIFQ-7)
timeFrame: 6 months after intervention (operation or start of pelvic floor training)
measure: Prolapse Incontinence Sexual Questionnaire (PISQ)
timeFrame: 6 months after intervention (operation or start of pelvic floor training)
measure: Hospital Anxiety and Depression Scale (HAD)
timeFrame: 6 months after intervention (operation or start of pelvic floor training)
measure: Vaginal symptoms
timeFrame: 6 months after intervention (operation or start of pelvic floor training)
measure: Surgical complications
timeFrame: From surgery up to 6 months postoperatively
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Södersjukhuset
Study officials:
affiliation: Stockholm South General Hospital
name: Marion Ek, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.