A randomized prospective comparison of the needleless mini-sling "hammock" and "U-shape" configurations for management of stress urinary incontinence: 18 month follow-up results.

OBJECTIVE

To compare the efficacy of needleless mini-sling placed either retropubic (U-shape) or trans-obturator (hammock-shape) to treat stress urinary incontinence.

SETTING

One hundred and twenty six women were randomized in a 2:1 ratio to receive hammock-shaped or U-shaped of Contasure-NDL.

METHODS

All surgical procedures were performed by one senior surgeon experienced in anti-incontinence surgery with mesh. Cough-stress test was considered for objective outcome. Subjective outcomes consisted of International Consultation on Incontinence Questionnaire Short Form (ICIQ-SF), Patient Global Impression of Improvement (PGI-I) and three-item Likert scale to measure satisfaction. Assessments were performed preoperatively and at postoperative 6th, 12th and 18th month.

RESULTS

The objective cure rates at postoperative 6th and 12th month were significantly lower in U-shape group compared to hammock-shape group (85.4 vs. 96.4%; p = 0.034) and was comparable with hammock-shape group at 18 month postoperative (90.2 vs. 96.4%, respectively; p = 0.216). The subjective cure rates at postoperative 6th, 12th and 18th month were similar between groups (90.2/90.2/100% vs. 96.4/96.4/96.4%, respectively; p > 0.05). Median of total ICIQ-SF scores was significantly lower in hammock-shaped group (1.62 ± 2.92) compared to U-shape (3.80 ± 2.64) at 18th month (p < 0.001). The rate of patients reported as very satisfied or satisfied to the Likert scale was 90.2% in U-shape group and 96.4% in hammock group. Patients' responses to PGI-I were majorly distributed to "much better" and "very much better" with a mean score of 1.93 ± 2 in U-shape and 1.33 ± 1 in hammock group at 18th month of follow-up (p < 0.001).

CONCLUSION

U-shape placement of needleless single-incision mini-sling mimicking the retropubic route did not satisfy in achieving the patient's goal when compared to hammock-shape placement.