[Transurethral injection of polyacrylamide hydrogel (Bulkamid®) for the treatment of female stress urinary incontinence and changes in the cure rate over time].

OBJECTIVE

The objective of this study was to evaluate short term and long term efficacy of a transurethral injection (TUI) using bulking agent Bulkamid® for female stress (SUI) and mixed urinary incontinence by women with ISD or where anti-incontinence surgery has failed.

DESIGN

Retrospective clinical study.

SETTINGS

Gynecological and Obstetric Dpt. 1st Medical Faculty UK and VFN, Prague.

MATERIALS AND METHODS

A retrospective study was performed on 52 women with urinary incontinence (stress, 43; mixed 9). One patient died during study. Forty patients had previously undergone anti-incontinence surgery. The efficacy of TUI was evaluated 3 months (± 1 week) and an average of 22 months after surgery. Subjective assessment of the leakage of urine was based on the International Consultation on Incontinence Questionnaire - Short form (ICIQ-UI SF) filled in before, three and - on average - 22 months after the surgery (minimum time after surgery was 6 months). Improvement in urinary incontinence was defined as a drop in the score of more than 50%. Objective assessment of leakage of urine was assessed by cough test. The cure effect was evaluated by VAS (Visual Analogue Scale) score and by using the five-point Likert score. Ethical committee approval was obtained, and all subjects gave written informed consent to participate in the study.

RESULTS

Mean age of patients was 70 years, mean body mass index (BMI) 28.65, and mean parity was 1.76. The cough test showed that 19/51 (37.3%) of patients had negative results for this test 3 months and 10/51 (19.6%) 22 months after the operation. The ICIQ-UI SF questionnaire showed that 16/51 (31.4%) of our patients were completely dry 3 months after the operation and 8/51 (15.7 %) 22 months after the operation. 41/51 (80.4%) of patients were dry or improved 3 months after the operation and 23/51 (45.13%) 22 months after the operation. The mean cure effect evaluated by VAS score 3 months after the operation was 72 and 22 months after the operation it was 51.3. The Likert score was 4 or 5 (cured or improved) three and 22 months after operation by 78.4% / 54.9% patients.

CONCLUSIONS

The cure effect of Bulkamid® operation decreases in correlation with the time that elapses after the operation, although this procedure is minimally invasive and is an option in cases where anti-incontinence surgery has failed.