Clinical trial NCT00743535: Anterior Defect Correction With Mesh Plus Treatment of Stress Incontinence With Transobturator or Transvaginal Approach
Official title: A Comparison in Terms of Efficacy and Safety Between Transobturator and Transvaginal Tape Performed at the Same Time of Anterior Defect Correction With Mesh
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Cystocele
Stress Urinary Incontinence
Keywords: Cystocele
Mesh
Prolapse
Sling
Stress incontinence
Surgery
TOT
TVT
Treatment
Lead sponsor: University Magna Graecia
Sponsor class: OTHER
First posted: 2008-08-29
Enrollment: 15
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

* Cystocele
* Genuine stress urinary incontinence by self report, examination and test
* Urethral hypermobility
* Eligible for both surgical procedures
* Ambulatory

Exclusion Criteria:

* 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

Primary outcomes:
measure: Objective/subjective symptoms improvements
timeFrame: 12 months
Secondary outcomes:
measure: Intra-operative complication rate
timeFrame: one day
measure: Postoperative complications rate
timeFrame: 12 months
measure: Failure rate
timeFrame: 12 months
measure: Recurrence rate
timeFrame: 12 months
measure: Quality of life
timeFrame: 12 months
measure: Sexual function
timeFrame: 12 months
Other outcomes:
Locations:
city: Catanzaro
country: Italy
facility: "Pugliese" Hospital
Study officials:
affiliation: Chair of Obstetrics and Gynecology, University "Magna Graecia" of Catanzaro
name: Stefano Palomba, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Chair of Obstetrics and Gynecology, University "Magna Graecia" of Catanzaro
name: Fulvio Zullo, MD
role: STUDY_CHAIR
References: