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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2011 by University Of Perugia.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
University Of Perugia
ClinicalTrials.gov Identifier:
NCT01384084
First received: June 27, 2011
Last updated: NA
Last verified: May 2011
History: No changes posted
  Purpose

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 Intervention Phase
Pelvic Organ Prolapse
Urinary Incontinence
Procedure: POP repair plus mini-sling
Procedure: POP repair
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (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

Resource links provided by NLM:


Further study details as provided by University Of Perugia:

Primary Outcome Measures:
  • urinary incontinence [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    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 [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]
    Operative time and morbidity according to Clavien-Dindo classification, post-operative complications, length of hospital stay.


Estimated Enrollment: 50
Study Start Date: June 2011
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01384084

Locations
Italy
Urology Dept. University of Perugia Recruiting
Perugia, Italy, 06100
Contact: Elisabetta Costantini, Associate Professor    00390755784416    ecostant@unipg.it   
Principal Investigator: Massimo Porena, Prof. in Chief         
Sponsors and Collaborators
University Of Perugia
  More Information

Publications:
Responsible Party: Prof. Massimo Porena, University of Perugia - Utology Dept.
ClinicalTrials.gov Identifier: NCT01384084     History of Changes
Other Study ID Numbers: UPerugia-1
Study First Received: June 27, 2011
Last Updated: June 27, 2011
Health Authority: Italy: Ministry of Education, University and Research

Keywords provided by University Of Perugia:
pelvic organ prolapse
urinary incontinence
sacropexy
sling

Additional relevant MeSH terms:
Prolapse
Urinary Incontinence
Pelvic Organ Prolapse
Pathological Conditions, Anatomical
Urination Disorders
Urologic Diseases
Urological Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on April 17, 2014