Anterior Defect Correction With Mesh Plus Treatment of Stress Incontinence With Transobturator or Transvaginal Approach
- Conditions
- CystoceleStress Urinary Incontinence
- Interventions
- Procedure: Transobturatory correction of anterior defect plus TOTProcedure: Transobturatory correction of anterior defect plus TVT
- Registration Number
- NCT00743535
- Lead Sponsor
- University Magna Graecia
- Brief Summary
The incidence of anterior pelvic defect in women is estimated about 10% and it may be often associated to urinary stress incontinence. To date the correction of anterior defects with the use of graft material inserted with transobturator approach has become of large use. Moreover, given the frequent association of urinary stress incontinence to anterior defect, in most of cases it becomes necessary to perform at the same time an anti-incontinence procedure, i.e. a sub-urethral sling positioning. Based on these considerations the aim of this trial will be to compare two different approach for sub-urethral sling positioning, transobturator and transvaginal tape (TOT and TVT) performed in association to transobturator correction of anterior defect with mesh in terms of efficacy and safety.
- Detailed Description
Women with anterior defect and genuine stress urinary incontinence will be enrolled and randomized in two groups (arm 1 and 2). All patients will be treated with a transobturator correction of anterior defect, in patients of arm 1 will be associated TOT, whereas in patients of arm 2 will be associated TVT.
All patients eligible will undergo baseline assessment consisting of anthropometric, clinical, hormonal, urodynamic, and ultrasonographic evaluations. During the study, the surgical outcomes, the clinical subjective and objective efficacy data, and the adverse experiences will be evaluated in each patient.
Data will be analyzed using the intention-to-treat principle and a P value of 0.05 or less will be considered significant.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- Female
- Target Recruitment
- 15
- Cystocele
- Genuine stress urinary incontinence by self report, examination and test
- Urethral hypermobility
- Eligible for both surgical procedures
- Ambulatory
- Pregnancy
- <12 months post-partum
- Systemic disease and/or drugs known to affect bladder function
- Current chemotherapy or radiation therapy
- Urethral diverticulum, augmentation cytoplasty, or artificial sphincter
- Recent pelvic surgery
- Previous pelvic or anti-incontinence surgery
- History of severe abdominopelvic infections
- Known extensive abdominopelvic adhesions
- Detrusor instability and/or intrinsic sphincter dysfunction
- Other gynaecologic pathologies (eg, fibroids, ovarian cysts)
- BMI >30
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1 Transobturatory correction of anterior defect plus TOT Transobturatory correction of anterior defect plus TOT 2 Transobturatory correction of anterior defect plus TVT Longitudinal vaginal incision 1 cm far from esternal urethral meatus. Bladder dissecting and identification of ischiatic spines. Bilateral transobturator insertion of anterior mesh through high and low trans-obturatory approach. Mesh anchorage. Small incision sites at sovrapubic level. Bilateral retropubic insertion of mesh by means of mono-use needle.
- Primary Outcome Measures
Name Time Method Objective/subjective symptoms improvements 12 months
- Secondary Outcome Measures
Name Time Method Intra-operative complication rate one day Postoperative complications rate 12 months Failure rate 12 months Recurrence rate 12 months Quality of life 12 months Sexual function 12 months
Trial Locations
- Locations (1)
"Pugliese" Hospital
🇮🇹Catanzaro, Italy