A new treatment of female stress urinary incontinence with vaginal antetheca-retropubic space mesh repair surgery: a clinical trial.

PURPOSE

To investigate the short- and medium-term effect of vaginal antetheca submucosal-retropubic space with mesh repair through the implantation of organic patch (shortly as new-style vaginal mesh repair) in the treatment of patients with stress urinary incontinence (SUI).

METHODS

This was a clinical prospective single arm study in a tertiary grade hospital (General Hospital of Jinan Military Region, Jinan, China). From January 2009 to December 2014, 316 female patients were enrolled. 316 female patients with stress urinary incontinence (SUI) underwent the surgery. The treatment effect was evaluated using the urinary incontinence questionnaire (ICIQ-SF), urine pad test and coughing test. The perioperative and postoperative complications were also evaluated. The results were compared with 1-year cure rates of Burch retropubic urethropexy (Burch) and tension-free vaginal tape (TVT) procedure.

RESULTS

The mean follow-up period was 25 ± 12 months. The success rate of the new surgical technique was 94.0% (297/316) at 1 month, and 91.5% (289/316) at 1-year postoperation. The ICIQ-SF score significantly decreased at the 1-year follow-up (P < 0.01). There was no significant difference in the 1-year cure rate when compared with the Burch and TVT procedures (P > 0.05). The rates of perioperative urinary tract irritation and mesh exposure were 9.5% (30/316) and 5.38% (17/316), respectively, and no serious complications were found.

CONCLUSIONS

The surgery demonstrated favorable short-term and medium-term treatment effects. Given its advantages of being minimally invasive, cost efficient and requiring only local anesthesia, this new surgical technique has a potential for broader clinical application. CLINICALTRIALS.

GOV ID

NCT02934490.