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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
70
Surgery for improperly healed perineal tear
Pelvic floor exercise tutored by physio therapist.
Södersjukhuset
Stockholm, Sweden
Patient Global Impression of Improvement (PGI-1)
Patients own assessment of improvement 6 months after intervention using a seven grade assessment tool called PGI-1
Time frame: 6 months after intervention (operation or start of pelvic floor training)
POP-Q (Pelvic organ Quantification System)
Pelvic organ prolapse is graded via the Pelvic organ Quantification System (POP-Q) into stage 0-4. It is a validated way to clinically assess and stage of the female pelvic floor.
Time frame: 6 months after intervention (operation or start of pelvic floor training)
Ultrasound of perineum
Height and depth of perineum i millimeters using ultrasonography
Time frame: 6 months after intervention (operation or start of pelvic floor training)
Pelvic floor distress inventory (PFDI 20)
20 validated questions concerning prolapse related symptoms
Time frame: 6 months after intervention (operation or start of pelvic floor training)
Pelvic Floor Impact Questionnaire (PIFQ-7)
Evaluates the effect on quality of lafe.
Time frame: 6 months after intervention (operation or start of pelvic floor training)
Prolapse Incontinence Sexual Questionnaire (PISQ)
Evaluate effects on sexual functions
Time frame: 6 months after intervention (operation or start of pelvic floor training)
Hospital Anxiety and Depression Scale (HAD)
Evaluate psychological effects
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: 6 months after intervention (operation or start of pelvic floor training)
Vaginal symptoms
Three non-validated questions concerning vaginal symptoms; sensation of wideness, vaginal flatulence and excessive discharge.
Time frame: 6 months after intervention (operation or start of pelvic floor training)
Surgical complications
Infections.Bleedings. Other complications.
Time frame: From surgery up to 6 months postoperatively