Prospective Evaluation of a Single Incision Sling for Stress Urinary Incontinence

Received 4 January 2010 published online 21 June 2010.

Purpose

We report 12-month outcomes of the MiniArc™ single incision sling for stress urinary incontinence in women.

Materials and Methods

We performed a multicenter, prospective, single arm institutional review board/ethics committee approved study evaluating the effectiveness of the MiniArc sling after implantation via qualitative (Urogenital Distress Inventory-Short Form and Incontinence Impact Questionnaire-Short Form) and quantitative (1-hour pad weight test and cough stress test) measurements. Secondary outcome measures included procedural variables (procedure time and estimated blood loss), length of stay, perioperative complications, Wong-Baker Faces Pain Scale and adverse events.

Results

A total of 188 women with a mean age of 51.1 ± 10.6 years (median 50.4, range 25.9 to 79.6) were enrolled in the study. At 1 year 157 patients were available for analysis. Mean procedure time, estimated blood loss and length of hospital stay were 11.0 ± 6.7 minutes (median 10, range 2 to 55), 41.7 ± 47.0 ml (median 25, range 0 to 250) and 9.5 ± 14.1 hours (median 3.2, range 0.5 to 77.2), respectively. At discharge from hospital the mean Wong-Baker pain score was 1.3 ± 2.0 (range 0.0 to 10.0). Of the patients 90.6% had a negative cough stress test and 84.5% had a 1-hour pad weight test less than 1 gm at 12 months. Median Urogenital Distress Inventory-Short Form and Incontinence Impact Questionnaire-Short Form scores showed a statistically significant decrease (p <0.001). Adverse events included urinary tract infection (4.3%), constipation (3.7%), temporary urinary retention (3.2%), dyspareunia (2.1%) and vaginal extrusion (1.6%).

Conclusions

The MiniArc single incision sling is a safe and effective first line surgical procedure for the treatment of female stress urinary incontinence. It demonstrated excellent patient tolerability with minimal pain, early return to normal activity and low morbidity. In addition to sustained efficacy outcomes at 12 months patients treated with the MiniArc experienced a significant improvement in quality of life.

Key Words: surgical procedures, minimally invasive, suburethral slings, urinary incontinence, stress

Abbreviations and Acronyms: CST, cough stress test, IIQ-7, Incontinence Impact Questionnaire-Short Form, LFCF, last failure carried forward, PWT, pad weight test, QOL, quality of life, SUI, stress urinary incontinence, TOT, transobturator tape, TVT, tension-free vaginal tape, UDI-6, Urogenital Distress Inventory-Short Form

McKay Urology Research, Charlotte, North Carolina, Atlanta Urogynecology Associates, Alpharetta, Georgia, Southern California Permanente Medical Group Female Pelvic Medicine & Reconstructive Surgery Obstetrics & Gynecology, Downey, California, Eastern Virginia Medical School, Norfolk, Virginia, and Metro Urology, St. Paul, Minnesota

Correspondence: Urology Department, McKay Urology Research, 1023 Edgehill Rd. S., Charlotte, North Carolina 28207 (telephone: 704-355-7466; FAX: 704-355-8687)

Study received institutional review board/ethics committee approval.

† Financial interest and/or other relationship with AMS, Bard, Allergan, Coloplast and Hollister.

‡ Financial interest and/or other relationship with AMS.

§ Financial interest and/or other relationship with AMS, Novasys and Pfizer.

∥ Financial interest and/or other relationship with AMS, Medtronic, Allergan, Uroplasty, GT Medical and QiG.

PII: S0022-5347(10)03288-X

doi:10.1016/j.juro.2010.04.003

52 of 107