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

Primary Purpose

Pelvic Organ Prolapse, Urinary Incontinence

Status
Completed
Phase
Phase 3
Locations
Italy
Study Type
Interventional
Intervention
POP repair plus mini-sling
POP repair
Sponsored by
University Of Perugia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pelvic Organ Prolapse focused on measuring pelvic organ prolapse, urinary incontinence, sacropexy, sling

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)FemaleDoes not accept 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

Exclusion Criteria:

  • fertile patients
  • contraindication to major surgery
  • uterine cancer

Sites / Locations

  • Urology Dept. University of Perugia

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

POP repair plus mini-sling

pelvic organ prolapse repair

Arm Description

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).

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

Outcomes

Primary Outcome Measures

urinary incontinence
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
Operative time and morbidity according to Clavien-Dindo classification, post-operative complications, length of hospital stay.

Full Information

First Posted
June 27, 2011
Last Updated
May 19, 2014
Sponsor
University Of Perugia
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1. Study Identification

Unique Protocol Identification Number
NCT01384084
Brief Title
Pelvic Organ Prolapse Repair Plus Mini-Sling Versus Pelvic Organ Prolapse Repair Alone
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 Type
Interventional

2. Study Status

Record Verification Date
May 2011
Overall Recruitment Status
Completed
Study Start Date
June 2011 (undefined)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
December 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Of Perugia

4. Oversight

Data Monitoring Committee
No

5. 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pelvic Organ Prolapse, Urinary Incontinence
Keywords
pelvic organ prolapse, urinary incontinence, sacropexy, sling

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
POP repair plus mini-sling
Arm Type
Experimental
Arm Description
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).
Arm Title
pelvic organ prolapse repair
Arm Type
Active Comparator
Arm Description
Patients affected by urogenital prolapsed and urinary incontinence, who are candidates for pelvic organ prolapsed repair using sacropexy, will receive sacropexy alone.
Intervention Type
Procedure
Intervention Name(s)
POP repair plus mini-sling
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
POP repair
Intervention Description
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.
Primary Outcome Measure Information:
Title
urinary incontinence
Description
long-term relief of symptoms with anatomic correction of prolapse and subjective/objective correction of urinary incontinence
Time Frame
12 months
Secondary Outcome Measure Information:
Title
peri and post-operative complications
Description
Operative time and morbidity according to Clavien-Dindo classification, post-operative complications, length of hospital stay.
Time Frame
1 month

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Urology Dept. University of Perugia
City
Perugia
ZIP/Postal Code
06100
Country
Italy

12. IPD Sharing Statement

Citations:
PubMed Identifier
21497843
Citation
Costantini E, Lazzeri M, Bini V, Del Zingaro M, Zucchi A, Porena M. Pelvic organ prolapse repair with and without prophylactic concomitant Burch colposuspension in continent women: a randomized, controlled trial with 8-year followup. J Urol. 2011 Jun;185(6):2236-40. doi: 10.1016/j.juro.2011.01.078. Epub 2011 Apr 16.
Results Reference
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PubMed Identifier
21152903
Citation
Costantini E, Lazzeri M, Zucchi A, Bini V, Mearini L, Porena M. Five-year outcome of uterus sparing surgery for pelvic organ prolapse repair: a single-center experience. Int Urogynecol J. 2011 Mar;22(3):287-92. doi: 10.1007/s00192-010-1342-7. Epub 2010 Dec 9.
Results Reference
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PubMed Identifier
20434257
Citation
Novara G, Artibani W, Barber MD, Chapple CR, Costantini E, Ficarra V, Hilton P, Nilsson CG, Waltregny D. Updated systematic review and meta-analysis of the comparative data on colposuspensions, pubovaginal slings, and midurethral tapes in the surgical treatment of female stress urinary incontinence. Eur Urol. 2010 Aug;58(2):218-38. doi: 10.1016/j.eururo.2010.04.022. Epub 2010 Apr 23.
Results Reference
background
PubMed Identifier
18639302
Citation
Costantini E, Lazzeri M, Bini V, Del Zingaro M, Zucchi A, Porena M. Burch colposuspension does not provide any additional benefit to pelvic organ prolapse repair in patients with urinary incontinence: a randomized surgical trial. J Urol. 2008 Sep;180(3):1007-12. doi: 10.1016/j.juro.2008.05.023. Epub 2008 Jul 17.
Results Reference
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Pelvic Organ Prolapse Repair Plus Mini-Sling Versus Pelvic Organ Prolapse Repair Alone

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