Pelvic Organ Prolapse Repair Plus Mini-Sling Versus Pelvic Organ Prolapse Repair Alone

Phase 3

Completed

• Conditions: Urinary Incontinence; Pelvic Organ Prolapse
• Interventions: Procedure: POP repair plus mini-sling; Procedure: POP repair

• Registration Number: NCT01384084
• Lead Sponsor: University Of Perugia

Brief Summary

The investigators have performed colposacropexy in women with uterovaginal prolapse for many years with satisfactory results.

This study was designed to compare whether, in the treatment of patients with uro-genital prolapse and urinary incontinence, the addition of a contemporary anti-incontinence procedure such as mini-sling is associated with a reduction of post-operative urinary incontinence (correction of pre-existent urinary incontinence and prevention of masked urinary incontinence).

Detailed Description

Not available

Study Timeline

• Status Verified: 2011-05
• Study Start: 2011-06
• Study First Submitted: 2011-06-27
• Study First Submitted QC: 2011-06-27
• Study First Posted: 2011-06-28
• Primary Completion: 2013-12
• Study Completion: 2013-12
• Last Update Submitted: 2014-05-19
• Last Update Posted: 2014-05-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 50

Inclusion Criteria

• Patients affected by III-IV grade urogenital urogenital prolapsed and urinary incontinence
• Candidates for pelvic organ prolapsed repair using sacropexy
• Prospectively randomized, using a predetermined computer-generated randomization code (4 blocks), to sacropexy plus anti-incontinence procedure (mini-sling) or sacropexy alone

Exclusion Criteria

• fertile patients
• contraindication to major surgery
• uterine cancer

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
POP repair plus mini-sling	POP repair plus mini-sling	Patients affected by urogenital prolapse and urinary incontinence, who are candidates for pelvic organ prolapsed repair using sacropexy, will receive sacropexy plus anti-incontinence procedure (mini-sling).
pelvic organ prolapse repair	POP repair	Patients affected by urogenital prolapsed and urinary incontinence, who are candidates for pelvic organ prolapsed repair using sacropexy, will receive sacropexy alone.

Primary Outcome Measures

Name	Time	Method
urinary incontinence	12 months	long-term relief of symptoms with anatomic correction of prolapse and subjective/objective correction of urinary incontinence

Secondary Outcome Measures

Name	Time	Method
peri and post-operative complications	1 month	Operative time and morbidity according to Clavien-Dindo classification, post-operative complications, length of hospital stay.

Trial Locations

Locations (1)

Urology Dept. University of Perugia; 🇮🇹 Perugia, Italy