---
title: Anterior Defect Correction With Mesh Plus Treatment of Stress Incontinence With Transobturator or Transvaginal Approach
nct_id: NCT00743535
overall_status: TERMINATED
phase: PHASE4
sponsor: University Magna Graecia
study_type: INTERVENTIONAL
primary_condition: Cystocele
countries: Italy
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT00743535.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT00743535"
ct_last_update_post_date: 2013-04-08
last_seen_at: "2026-05-12T06:47:38.785Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# 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

**NCT ID:** [NCT00743535](https://clinicaltrials.gov/study/NCT00743535)

## Key Facts

- **Status:** TERMINATED
- **Why Stopped:** Low recruitment rate.
- **Phase:** PHASE4
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 15
- **Lead Sponsor:** University Magna Graecia
- **Conditions:** Cystocele, Stress Urinary Incontinence
- **Start Date:** 2008-02
- **CT.gov Last Update:** 2013-04-08

## 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

- **Minimum age:** 18 Years
- **Maximum age:** 80 Years
- **Sex:** FEMALE
- **Healthy Volunteers:** No

```
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
```

## Arms

- **1** (EXPERIMENTAL) — Transobturatory correction of anterior defect plus TOT
- **2** (ACTIVE_COMPARATOR) — 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.

## Interventions

- **Transobturatory correction of anterior defect plus TOT** (PROCEDURE) — 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 in the femoral/pelvic fold. Bilateral transobturator insertion of mesh by means of mono-use needle
- **Transobturatory correction of anterior defect plus TVT** (PROCEDURE) — 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 Outcomes

- **Objective/subjective symptoms improvements** _(time frame: 12 months)_

## Secondary Outcomes

- **Intra-operative complication rate** _(time frame: one day)_
- **Postoperative complications rate** _(time frame: 12 months)_
- **Failure rate** _(time frame: 12 months)_
- **Recurrence rate** _(time frame: 12 months)_
- **Quality of life** _(time frame: 12 months)_
- **Sexual function** _(time frame: 12 months)_

## Locations (1)

- "Pugliese" Hospital, Catanzaro, Catanzaro, Italy

## Recent Field Changes (last 30 days)

- `eligibility.criteria` — added _(2026-05-12)_
- `status.overallStatus` — added _(2026-05-12)_
- `status.whyStopped` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.maxAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations."pugliese" hospital|catanzaro|catanzaro|italy` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT00743535.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT00743535*  
*This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*