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

Sponsor

University Of Perugia (Other)

Overall Status

Completed

CT.gov ID

NCT01384084

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

1.7

Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Pelvic Organ Prolapse Urinary Incontinence	Procedure: POP repair plus mini-sling Procedure: POP repair	Phase 3

Study Design

Study Type:

Interventional

Actual Enrollment :

50 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

URINARY INCONTINENCE AND URO-GENITAL PROLAPSE: A RANDOMIZED TRIAL OF PELVIC ORGAN PROLAPSE REPAIR PLUS MINI-SLING VERSUS PELVIC ORGAN PROLAPSE REPAIR ALONE

Study Start Date :

Jun 1, 2011

Actual Primary Completion Date :

Dec 1, 2013

Actual Study Completion Date :

Dec 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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).	Procedure: POP repair plus mini-sling For POP, the anterior vaginal wall is dissected from the bladder to expose a vaginal wall area where the mesh will be attached. The procedure is repeated for the posterior vaginal wall. The sacral promontory surface is prepared and 1 non-reabsorbable sutures are placed into the sacral periosteum. A mini sling system will be used, placing a urethral low-tension tape anchored to the obturator muscles bilaterally at the level of tendinous arc. This mini-sling is a polypropylene monofilament mesh.
Active Comparator: pelvic organ prolapse repair Patients affected by urogenital prolapsed and urinary incontinence, who are candidates for pelvic organ prolapsed repair using sacropexy, will receive sacropexy alone.	Procedure: POP repair For POP repair, the anterior vaginal wall is dissected from the bladder to expose a vaginal wall area where the mesh will be attached. The procedure is repeated for the posterior vaginal wall. The sacral promontory surface is prepared and 1 non-reabsorbable sutures are placed into the sacral periosteum. The peritoneum is closed over the meshes.

Arm

Intervention/Treatment

Experimental: 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).

Procedure: POP repair plus mini-sling

For POP, the anterior vaginal wall is dissected from the bladder to expose a vaginal wall area where the mesh will be attached. The procedure is repeated for the posterior vaginal wall. The sacral promontory surface is prepared and 1 non-reabsorbable sutures are placed into the sacral periosteum. A mini sling system will be used, placing a urethral low-tension tape anchored to the obturator muscles bilaterally at the level of tendinous arc. This mini-sling is a polypropylene monofilament mesh.

Active Comparator: pelvic organ prolapse repair

Patients affected by urogenital prolapsed and urinary incontinence, who are candidates for pelvic organ prolapsed repair using sacropexy, will receive sacropexy alone.

Procedure: POP repair

For POP repair, the anterior vaginal wall is dissected from the bladder to expose a vaginal wall area where the mesh will be attached. The procedure is repeated for the posterior vaginal wall. The sacral promontory surface is prepared and 1 non-reabsorbable sutures are placed into the sacral periosteum. The peritoneum is closed over the meshes.

Outcome Measures

Primary Outcome Measures

urinary incontinence [12 months]
long-term relief of symptoms with anatomic correction of prolapse and subjective/objective correction of urinary incontinence

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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