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

NCT01384084 | Completed Phase 3

• 1 other identifier: UPerugia-1
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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).

Conditions

Pelvic Organ Prolapse; Urinary Incontinence

Keywords

pelvic organ prolapse; urinary incontinence; sacropexy; sling

Outcome Measures

Primary Outcomes (1)

• urinary incontinence

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

  12 months

Secondary Outcomes (1)

• peri and post-operative complications

  1 month

Study Arms (2)

POP repair plus mini-sling

EXPERIMENTAL

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

pelvic organ prolapse repair

ACTIVE COMPARATOR

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

Interventions

POP repair plus mini-sling PROCEDURE

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.

POP repair plus mini-sling

POP repair PROCEDURE

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.

pelvic organ prolapse repair

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• fertile patients
• contraindication to major surgery
• uterine cancer

Sponsors & Collaborators

• University Of Perugia: lead

Study Sites (1)

Urology Dept. University of Perugia

Perugia, 06100, Italy

Location

Related Publications (5)

• 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.

  PMID: 21497843 BACKGROUND

• 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.

  PMID: 21152903 BACKGROUND

• 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.

  PMID: 20434257 BACKGROUND

• 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.

  PMID: 18639302 BACKGROUND

• Carter E, Johnson EE, Still M, Al-Assaf AS, Bryant A, Aluko P, Jeffery ST, Nambiar A. Single-incision sling operations for urinary incontinence in women. Cochrane Database Syst Rev. 2023 Oct 27;10(10):CD008709. doi: 10.1002/14651858.CD008709.pub4.

  PMID: 37888839 DERIVED

MeSH Terms

Conditions

Pelvic Organ Prolapse; Urinary Incontinence

Condition Hierarchy (Ancestors)

Prolapse; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: senior assistant

Study Record Dates

• First Submitted: June 27, 2011
• First Posted: June 28, 2011
• Study Start: June 1, 2011
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: May 20, 2014

Record last verified: 2011-05

Locations

IT (1)