INTRODUCTION: The Ophira mini-sling system (Promedon; Cordoba, Argentina) uses a minimally invasive, midurethral low-tension tape that is anchored to the obturator internus muscles bilaterally at the level of the tendinous arc by a single vaginal incision. It minimizes surgical trauma and enables an outpatient procedure. First-year follow-up results are reported.
METHODS: The study was a prospective clinical trial conducted from February 2008 to March 2010. Participants were 149 female patients with stress urinary incontinence from Brazil and Argentina. Their mean age was 53.9 years (SD = 9.5; range, 36-71 years). All patients received a medical history, physical examination, stress test, standardized 1-hour pad test, and urodynamic study. Patients also completed the International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF) and Urogenital Distress Inventory (UDI-6). All underwent treatment with the Ophira mini-sling system. The procedure was conducted under local (73%), general (18%), or regional anesthesia (9%). A vertical 1 cm long vaginal incision was performed at 1 cm from the urethral meatus to deliver the prosthesis. Patients repeated the presurgical tests at 1, 3, 6, and 12 months after surgery. Outcome measures were postvoid residual volume, pad and stress test results, ICIQ-SF and UDI-6 scores, and complications. Means and standard deviations were calculated and tabled.
RESULTS: The mean (SD) operative time was 12.6 (7.4) minutes. One patient receiving the procedure under local anesthesia had severe intraoperative pain and needed intravenous sedation. Severe bleeding and technical problems with the device were not observed. The mean follow-up was 9 months; 91 patients had 12 months of follow-up evaluations. Postvoid residual volumes were variable across time. Pad tests showed less urine leakage after surgery. The percentage of patients with a positive stress test dramatically decreased after surgery. ICIQ-SF and UDI-6 scores also decreased. Major complications were not observed. Minor complications were mesh exposure (n = 3), urinary retention (n = 3), urinary tract infection (n = 8), and de novo urge incontinence (n = 7).
CONCLUSIONS: The Ophira mini-sling system appears to be an effective, minimally invasive option for the treatment of stress urinary incontinence.
Paulo Palma, Cassio Riccetto, Rodrigo Castro, Sebastian Altuna, Viviane Herrmann, Ricardo Miyaoka
Submitted March 18, 2011 - Accepted for Publication April 6, 2011
KEYWORDS: Female urinary incontinence; Treatment; Minimally invasive surgery; Mini-sling
CORRESPONDENCE: Dr. Ricardo Miyaoka, Rua Durval Cardoso, 172, Jardim Guarani, Campinas, Sao Paulo, Brazil ().
CITATION: Urotoday Int J. 2011 Jun;4(3):art44. doi:10.3834/uij.1944-5784.2011.06.14.
ABBREVIATIONS AND ACRONYMS: ICIQ-SF, International Consultation on Incontinence Questionnaire-Short Form; SUI, stress urinary incontinence; TOT, transobturator tape; TVT-S, tension-free vaginal tape-Secur; UDI-6, Urogenital Distress Inventory; UTI, urinary tract infection.