Pelvic Organ Prolapse Repair Plus Mini-Sling Versus Pelvic Organ Prolapse Repair Alone - Full Text View

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:

MedlinePlus related topics: Pelvic Support Problems Urinary Incontinence

U.S. FDA Resources

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.

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:

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. Epub 2011 Apr 16.

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 Pelvic Floor Dysfunct. 2011 Mar;22(3):287-92. Epub 2010 Dec 9.

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. Epub 2010 Apr 23. Review.

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. Epub 2008 Jul 17.

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 June 17, 2013