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.
RCT Entities:
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.