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

This study is currently recruiting participants.

Verified May 2011 by University Of Perugia

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

Tracking Information
First Received Date ^ICMJE	June 27, 2011
Last Updated Date	June 27, 2011
Start Date ^ICMJE	June 2011
Estimated Primary Completion Date	December 2012 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: June 27, 2011)	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
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	No Changes Posted
Current Secondary Outcome Measures ^ICMJE (submitted: June 27, 2011)	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.
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Pelvic Organ Prolapse Repair Plus Mini-Sling Versus Pelvic Organ Prolapse Repair Alone
Official Title ^ICMJE	URINARY INCONTINENCE AND URO-GENITAL PROLAPSE: A RANDOMIZED TRIAL OF PELVIC ORGAN PROLAPSE REPAIR PLUS MINI-SLING VERSUS PELVIC ORGAN PROLAPSE REPAIR ALONE
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).
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 3
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment
Condition ^ICMJE	Pelvic Organ Prolapse Urinary Incontinence
Intervention ^ICMJE	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.
Study Arm (s)	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
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.
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Recruiting
Estimated Enrollment ^ICMJE	50
Estimated Completion Date	December 2013
Estimated Primary Completion Date	December 2012 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Female
Ages	18 Years to 75 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Not Provided
Location Countries ^ICMJE	Italy

Administrative Information
NCT Number ^ICMJE	NCT01384084
Other Study ID Numbers ^ICMJE	UPerugia-1
Has Data Monitoring Committee	No
Responsible Party	Prof. Massimo Porena, University of Perugia - Utology Dept.
Study Sponsor ^ICMJE	University Of Perugia
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	University Of Perugia
Verification Date	May 2011
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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