Medium-term safety outcomes in patients undergoing tension free vaginal tape obturator for stress urinary incontinence in Murcia, Spain. Historical cohort.

OBJECTIVE

Describe the medium-term safety of the tension free vaginal tape obturator (TVT-O) procedure in terms of complications, cure and changes in quality of life (QoL) after the surgery.

MATERIALS AND

METHODS

Descriptive historical cohort that included women over 18 years of age who underwent TVT-O due to objectively proven stress urinary incontinence, urethral hypermobility or mixed urinary incontinence in which the stress component predominated, confirmed on urodynamic testing between July 2013-April 2017, in a reference hospital located in the city of Murcia Spain. Women with previous anti-incontinence surgery, concomitant vaginal surgery and planning pregnancy were excluded. Follow-up was determined for each patient based on the time elapsed between surgery and the time when the research protocol was applied. Complications were stratified according to the modified Clavien-Dindo classification; also we evaluated subjective cure rate, quality of life using the ICIQ-SF score, before and after surgery.

RESULTS

The mean age was 52.6 (SD± 10.5) years and 80.1% of patients were at least overweight. The incidence of complications at 12 months was: 8.3% (12/144). We did not detect complications after this period in the followed patients at 24, 36 and 48 months. The subjective cure determined at 12, 24, 36 and 48 months was 62.5% (90/144), 59.09% (55/88), 50.81% (31/61) and 50% (7/14), respectively. There was a significant improvement in quality of life, as determined by the ICQ-SF mean score before and after surgery (13.76[6,34] vs 3.84[5.76]; p<0.05).

CONCLUSIONS

The TVT-O surgery is a safe therapy associated with a low complication incidence at 12 months, an acceptable subjective cure rate in stress urinary incontinence, and quality-of-life improvement. Classifications of complications related to the insertion of the prosthesis and of those inherent to surgery, such as urinary tract infection, are required.