Clinical trial NCT00751088: A Randomized Controlled Study Comparing Three Single-incision Devices for Female Urinary Stress Incontinence
Official title: A Comparison Among Three Single-incision Devices for the Treatment of Female Urinary Genuine Stress Incontinence: a Randomized Controlled Study.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Urinary Incontinence
Keywords: single-incision
sling
stress incontinence
surgery
treatment
Female urinary stress incontinence
Lead sponsor: University Magna Graecia
Sponsor class: OTHER
First posted: 2008-09-11
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The prevalence of urinary stress incontinence in middle age women is rated at about 30%. To date, there is an increasing use in the clinical practice of new techniques for the treatment of this condition and several surgical devices, characterized by minimally invasive approach, are commercialized.

Recently, single-incision devices have been proposed. One of the most relevant potential advantages of these devices is the possibility of performing their positioning under local anesthesia, thus, in ambulatory regimen. The employment of these devices is particularly useful in two subgroups of patients with urinary incontinence, i.e. women with genuine stress incontinence not associated to pelvic organ prolapse (POP) and women whose stress incontinence raised after surgical correction of (severe) POP.

Poor data coming from randomized controlled trials (RCTs) are available regarding single-incision devices for the treatment of stress incontinence, and there are no conclusions in terms of their feasibility, efficacy and safety. Finally, to our knowledge no randomized controlled trial is actually available in literature comparing different single-incision devices.

Detailed description: Women with genuine urinary stress incontinence not associated with POP will be enrolled and randomized in three groups (arm 1, arm 2 and arm 3). All patients eligible will undergo baseline assessment consisting of anthropometric, clinical, hormonal, ultrasonographic and urodynamic evaluations. At time of surgery, all patients will be randomized in three surgical treatment groups (arm 1, 2 and 3). Patients of arm 1 will be treated with positioning of Ajust (Bard Urological Division, Covington, GA, USA), patients of group 2 will be treated with positioning of MiniArc (AMS, Minnetonka, MN, USA) and patients of arm 3 will be treated with positioning of TVT Secur System (Ethicon, Somerville, NJ, USA).

During the study, the clinical outcomes, and the adverse experience will be evaluated in each patient.

Data will be analyzed using the intention-to-treat principle and a P value of 0.05 or less will be considered significant.

Eligibility criteria: Inclusion Criteria:

* genuine stress incontinence

Exclusion Criteria:

* pregnancy
* \<12 months postpartum
* systemic disease and/or drugs known to affect bladder function
* current chemotherapy or radiation therapy
* urethral diverticulum
* augmentation cytoplasty
* artificial sphincter
* genital prolapse equal to or more than second degree
* history of severe abdominopelvic infections
* detrusor instability and/or intrinsic sphincter dysfunction
* other gynecologic pathologies
* BMI \>30

Primary outcomes:
measure: Subjective cure rate (compared to results of TVT)
Secondary outcomes:
measure: Objective cure rate
measure: Intraoperative complication rate
timeFrame: one day
measure: Blood loss
measure: Postoperative complication rate
timeFrame: thirty days
measure: Long-term complication rate
timeFrame: twelve months
measure: Postoperative pain
measure: Patients' satisfaction
measure: Sexual function
measure: Quality of life
measure: Recurrence rate
measure: Feasibility (degree of surgical difficulty in non-trained surgeons)
measure: Learning curve (change in operative time, intra- and post-operative complications over the time
Other outcomes:
Locations:
city: Catanzaro
country: Italy
facility: "Pugliese" Hospital
Study officials:
affiliation: Chair of Obstetrics and Gynecology, University "Magna Graecia" of Catanzaro
name: Stefano Palomba, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Chair of Obstetrics and Gynecology, University "Magna Graecia" of Catanzaro
name: Fulvio Zullo, MD
role: STUDY_CHAIR
References:
citation: Palomba S, Falbo A, Oppedisano R, Torella M, Materazzo C, Maiorana A, Tolino A, Mastrantonio P, La Sala GB, Alio L, Colacurci N, Zullo F; SIMS Italian Group. A randomized controlled trial comparing three single-incision minislings for stress urinary incontinence. Int Urogynecol J. 2014 Oct;25(10):1333-41. doi: 10.1007/s00192-014-2383-0. Epub 2014 Apr 16.
citation: Palomba S, Oppedisano R, Falbo A, Torella M, Maiorana A, Materazzo C, Tolino A, Mastrantonio P, La Sala GB, Alio L, Colacurci N, Zullo F; SIMS Italian Group. Single-incision mini-slings versus retropubic tension-free vaginal tapes: a multicenter clinical trial. J Minim Invasive Gynecol. 2014 Mar-Apr;21(2):303-10. doi: 10.1016/j.jmig.2013.08.714. Epub 2013 Oct 19.
citation: Palomba S, Oppedisano R, Torella M, Falbo A, Maiorana A, Materazzo C, Tartaglia E, Tolino A, Mastrantonio P, Alio L, Colacurci N, Zullo F; SIMS Italian Group. A randomized controlled trial comparing three vaginal kits of single-incision mini-slings for stress urinary incontinence: surgical data. Eur J Obstet Gynecol Reprod Biol. 2012 Jul;163(1):108-12. doi: 10.1016/j.ejogrb.2012.03.038. Epub 2012 May 1.