Clinical trial NCT01384084: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Pelvic Organ Prolapse
Urinary Incontinence
Keywords: pelvic organ prolapse
urinary incontinence
sacropexy
sling
Lead sponsor: University Of Perugia
Sponsor class: OTHER
First posted: 2011-06-28
Enrollment: 50
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


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

Primary outcomes:
measure: urinary incontinence
timeFrame: 12 months
Secondary outcomes:
measure: peri and post-operative complications
timeFrame: 1 month
Other outcomes:
Locations:
city: Perugia
country: Italy
facility: Urology Dept. University of Perugia
Study officials:
References:
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.
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.
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.
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.