A randomized controlled trial comparing three vaginal kits of single-incision mini-slings for stress urinary incontinence: surgical data

Abstract Objective Single-incision mini-slings (SIMS) are new minimally invasive devices used for female stress urinary incontinence (SUI). To date, several SIMS are available, but few and uncontrolled comparative data have assessed their safety and feasibility. The aim of the present clinical study...

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Bibliographic Details
Published in:European journal of obstetrics & gynecology and reproductive biology 2012-07, Vol.163 (1), p.108-112
Main Authors: Palomba, Stefano, Oppedisano, Rosamaria, Torella, Marco, Falbo, Angela, Maiorana, Antonio, Materazzo, Caterina, Tartaglia, Eduardo, Tolino, Achille, Mastrantonio, Pasquale, Alio, Luigi, Colacurci, Nicola, Zullo, Fulvio
Format: Article
Language:English
Subjects:
Aged
Ajust
Ambulatory Surgical Procedures
Anesthesia, Local
Double-Blind Method
Female
Gynecologic Surgical Procedures - methods
Humans
Middle Aged
Miniarc
Minislings
Obstetrics and Gynecology
Patient Satisfaction
Postoperative Complications
Single incision device
Stress incontinence
Suburethral Slings - adverse effects
TVT Secur System
Urinary incontinence
Urinary Incontinence, Stress - surgery
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Summary:Abstract Objective Single-incision mini-slings (SIMS) are new minimally invasive devices used for female stress urinary incontinence (SUI). To date, several SIMS are available, but few and uncontrolled comparative data have assessed their safety and feasibility. The aim of the present clinical study was to compare three different SIMS in an ambulatory setting. Study design One hundred and twenty patients with SUI were randomized to receive three SIMS: Ajust® , MiniArc® , and TVT Secur System® . Surgical data were compared. Results Significantly ( P < 0.05) lower surgical difficulty and higher patient satisfaction were detected in the MiniArc® group when compared to the Ajust® and TVT Secur System® groups. A significantly ( P < 0.05) higher feasibility under local anesthesia and in ambulatory setting was also detected for the MiniArc® group. The overall complication rate was significantly ( P < 0.05) lower in the MiniArc® group than in the TVT Secur System® group. Conclusions MiniArc® is simpler to insert under local anesthesia and in an ambulatory setting. It is safer than the TVT Secur System® , and is related to higher patient satisfaction.
ISSN:0301-2115
1872-7654
DOI:10.1016/j.ejogrb.2012.03.038