STUDY OBJECTIVE

To estimate the short-term effects of a minimally invasive single vaginal incision technique without passing through the abdomen or groin (ContaSure Needleless System) on the quality of life in women with incontinence.

DESIGN

Prospective cohort study (Canadian Task Force classification II-2).

SETTING

Tertiary referral urogynecology clinic.

PATIENTS

50 consecutive patients with urodynamically proved stress urinary incontinence from October 2008 to March 2009.

INTERVENTIONS

Preoperative and postoperative scores on the short forms of the IIQ-7 (Incontinence Impact Questionnaire, UDI-6 (Urinary Distress Inventory) PISQ-12 (Pelvic Organ Prolapse/Urinary Incontinence Sexual Function), and long form of the P-QOL (Prolapse Quality of Life) were evaluated in 50 patients with urodynamically proved stress urinary incontinence. Scores were compared with postoperative urodynamic findings.

MEASUREMENTS AND MAIN RESULTS

Mean (SD) follow-up was 433.5 (44.1) days (95% CI, 420.1-445.1). Patients showed statistically significant improvement insofar as preoperative and postoperative scores on the IIQ-7, P-QOL, and PISQ-12 and the irritative and stress subgroups of UDI-6. Obstructive score of UDI-6 worsened, consistent with the findings of pressure-flow studies. Postoperatively, 40 patients (80%) were urodynamically continent. Eight patients (16%) were still incontinent; however, their quality of life scores (IIQ-7 and UDI-6 stress) improved. Two patients (4%) continued to experience leakage, with equal or worsened quality-of-life scores.

CONCLUSION

Early clinical results of the present trial demonstrate that the ContaSure Needleless System seems to be capable of improving significantly all aspects of quality of life in women with incontinence. To improve the willingness for treatment of women with stress incontinence, this minimally invasive technique should be encouraged after confirming its efficacy in larger prospective, randomized, comparative trials.