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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Luigi Mearini, University Of Perugia
ClinicalTrials.gov Identifier:
NCT01384084
First received: June 27, 2011
Last updated: May 19, 2014
Last verified: May 2011

June 27, 2011
May 19, 2014
June 2011
December 2013   (final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01384084 on ClinicalTrials.gov Archive Site
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.
Same as current
Not Provided
Not Provided
 
Pelvic Organ Prolapse Repair Plus Mini-Sling Versus Pelvic Organ Prolapse Repair Alone
URINARY INCONTINENCE AND URO-GENITAL PROLAPSE: A RANDOMIZED TRIAL OF PELVIC ORGAN PROLAPSE REPAIR PLUS MINI-SLING VERSUS PELVIC ORGAN PROLAPSE REPAIR ALONE

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).

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
  • Pelvic Organ Prolapse
  • Urinary Incontinence
  • 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.

  • 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.
  • 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).
    Intervention: Procedure: POP repair plus mini-sling
  • 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.
    Intervention: Procedure: POP repair

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
50
December 2013
December 2013   (final data collection date for primary outcome measure)

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
Female
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
Italy
 
NCT01384084
UPerugia-1
No
Luigi Mearini, University Of Perugia
University Of Perugia
Not Provided
Not Provided
University Of Perugia
May 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP