Transurethral injection of polyacrylamide hydrogel (Bulkamid) for the treatment of female stress urinary inkontinence and changes in the cure rate over time

Czech version

Authors: A. Martan; J. Mašata; K. Švabík; R. El-Haddad; P. Hubka
Authors‘ workplace: Gynekologicko-porodnická klinika VFN a 1. LF UK, Praha
Published in: Ceska Gynekol 2011; 76(6): 476-481
Category: Original Article

Overview

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 and mixed urinary incontinence. The hypothesis was that the cure rate of Bulkamid may slowly decreases over time.

Design:
Retrospective clinical study.

Settings:
Gynecological and Obstetric Clinic, 1 LF UK and VFN, Prague.

Materials and methods:
A retrospective study was performed on 25 women with urinary incontinence (stress 18; mixed 7), and 24 patients completed the study. Nineteen patients had previously undergone anti-incontinence surgery. The efficacy of TUI was evaluated 3 months (±1 week) and an average of 13.5 months (range 6-30 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 and three and - on average – 13.5 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. Ethical committee approval was obtained, and all subjects gave written informed consent to participate in the study.

Results:
Mean age of patients was 69.7 (SD 16.22) years, mean body mass index (BMI) 27.56 (SD 3.42), and mean parity was 1.73 (SD 0.7).

Objective assessment by cough test showed that 9/25 (36%) of patients had negative results for this test 3 months and 4/24 (16.7%) 13.5 months after the operation. Subjective assessment by the ICIQ-UI SF questionnaire showed that 7/25 (28%) of our patients were completely dry 3 months after the operation and 3/24 (12,5%) 13 months after the operation. 20/25 (80%) of patients were dry or improved 3 months after the operation and 14/24 (58.3%) 13.5 months after the operation. The mean score before the operation was 17.56 (SD 3.44), median 18; 3 months after the operation it was 5.68 (SD 5.51), median 5; and 13.5 months after the operation it was 8.25 (SD 5.49), median 7.5. The evaluation of the answers to the question “Overall, how much does leaking urine interfere with your everyday life?” showed a worsening of the situation to a statistical significant degree: 3 months after the operation the mean score was 2.38 (SD 2.28), while 13.5 months after the operation it was 3.79 (SD 2.96).

Conclusions:
The hypothesis that the cure rate of Bulkamid may slowly decreases as time passes after the operation was confirmed.

Key words:
female urinary incontinence, anti-incontinence surgery, Bulkamid.

Sources

1. Botlero, R., Urquhart, DM., Davis, SR., Bell, RJ. Prevalence and incidence of urinary incontinence in women: review of the literature and investigation of methodological issues. Int Urol J, 2008, 15, p. 230-234.

2. Corcos, J., Collet, JP., Shapiro, S., et al. Multicenter randomized clinical trial comparing surgery and collagen injections for treatment of female stress urinary incontinence. Urology, 2005, 65, p. 898-904.

3. Isom-Batz, G., Zimmern, PE. Collagen injection for female urinary incontinence after urethral or periurethral surgery. J Urol, 2009, 181, p. 701-704.

4. Keegan, PE., Atiemo, K., Cody, J., et al. Periurethral injection therapy for urinary incontinence in women. Cochrane Database Syst. Rev. 3, 2007, CD003881.

5. Klarskov, N., Lose, G. Urethral injection therapy: what is the mechanism of action? Neurourol Urodyn, 2008, 27, p. 789‑792.

6. Kotb, AF, Campeau, L., Corcos, J. Urethral bulking agents: techniques and outcomes. Curr Urol Rep, 2009, 10, p. 396-400.

7. Lee, KS., Doo, CK., Han, DH., et al. Outcomes following repeat mid urethral synthetic sling after failure of the initial sling procedure: rediscovery of the tension-free vaginal tape procedure. J Urol, 2007, 178, p. 1370-1374.

8. Lee, HN., Lee, Y., Han, J., et al. Transurethral injection of bulking agent for treatment of failed mid-urethral sling procedures. Int Urogynecol J, 2010, 21, p. 1479-1483.

9. Lose, G., Sorensen, HC., Axelsen, SM., et al. An open multicenter study of polyacrylamide hydrogel (Bulkamid) for female stress and mixed urinary incontinence. Int Urogynecol J, 2010, 21, p. 1471-1477.

10. Lose, G., Mouritsen, L., Nielsan, JB. A new bulking agent (polyacrylamide hydrogel) for treating stress urinary incontinence in women. BJU Int, 2006, 98, p. 100-104.

11. Lord, H., Taylor, J., Finn, J., et al. A randomized controlled equivalence trial of short-term complications and efficacy of tension-free vaginal tape and suprapubic urethral support sling for treating stress incontinence. Brit J Urol, 2006, 98, p. 367-376.

12. Maher, CF., O’Reilly, BA., Dwyer, PL., et al. Pubovaginal sling versus transurethral Macroplastique for stress urinary incontinence and intrinsic sphincter deficiency: a prospective randomized controlled trial. BJOG, 2005, 112, p. 797-801.

13. Nilsson, CG., Falconer, C., Rezapour, M. Eleven years prospective follow-up of the tension-free vaginal tape procedure for treatment of stress urinary incontinence. Int Urogynecol J, 2008, 19, p. 1043-1047.

14. Robinson, D., Anders, K., Cardoso, L., et al. What do womenwant? Interpretation of the concept of cure. J Pelvic Med Surg, 2003, 9, p. 273-277.

15. Seo, JB., Lee, JZ. The epidemiologic study of the urinary incontinence in community-dwelling women over 50 years old. Korean J Urol, 1999, 40,. p. 1525-1530.

16. Sothers, L., Goldenberg, SL., Leone, EF. Complications of periurethral collagen injection for stress urinary incontinence. J Urol, 1998, 159, p. 806-807.

17. Tamussino, K., Hanzal, E., Kolle, D., et al. Tension-free vaginal tape operation: results of the Austrian registry. Obstet Gynecol, 2001, 98, p. 732-736.

18. Turnovsky, G., Tamusino, K., Greimel, E., Bjelic-Radisic, V. Quality of life after periurethral injection with polyacrylamide hydrogel for stress urinary incontinence. Int Urogynecol J, 2011, 22, p. 353-356.