Stress Urinary Incontinence
Conditions
Keywords
stress urinary incontinence, tension free vaginal tape, single incision minisling, midurethral sling
Brief summary
Based on previous studies the single incision minisling is an easy less invasive procedure with fewer complications and cure rate similar to conventional midurethral slings in the treatment of female stress urinary incontinence. The aim of this study is to test the hypothesis that the single incision mini-sling placed in the U position is not inferior to TVT in this patient population.
Interventions
PROCEDUREsingle incision minisling
midline incision of the vagina at midurethral level dissection of the vagina from perivesical fascia insertion of the tape (polypropylene macropore mesh tape) in the retropubic direction with its end grasped with an artery forceps till level of perineal membrane closure of the vagina 2 sham incisions if the skin only will be made at suprapubic to maintain blindness posterior colpoperneorraphy will be carried out if needed
PROCEDUREtension free vaginal tape
midline incision of the vagina at midurethral level dissection of the vagina from perivesical fascia insertion of the tape (polypropylene macropore mesh tape) with the applicators in the retropubic direction and 2 skin incision will be made supra pubic through which the applicators will be passed and removed and the tape will be cut at level just below the skin closure of the vagina posterior colpoperneorraphy will be carried out if needed
Sponsors
Ain Shams University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Healthy volunteers
No
Inclusion criteria
* Patients with urodynamic stress urinary incontinence, with or without pelvic organ prolapse
Exclusion criteria
* Patients with overactive bladder on urodynamic study. * Patients with voiding dysfunction. * Patients with intrinsic sphincteric deficiency. * Patients with previous anti-incontinence surgery. * Patients on anti-coagulant therapy. * Immune-compromised patients (DM, patients on corticosteroids treatment). * Refusal of surgery.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| objective cure rate of urinary incontinence at 12 months after surgery | 12 months | Objective cure is indicated by a negative stress test and the absence of any additional surgical or nonsurgical treatment for stress urinary incontinence |
| subjective cure rate of urinary incontinence at 12 months after surgery | 12 months | subjective cure is indicated by an Incontinence Severity Index score of 0 and the absence of any additional surgical or nonsurgical treatment for stress urinary incontinence |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with short- term complications | 12 months | short-term complications (less than 6 weeks): post-operative pain, urinary retention, denovo urgency and wound sepsis |
| Number of participants with long-term complications | 12 months | long-term complications: erosion, dyspareunia and recurrence |
Countries
Egypt
Outcome results
None listed