Transurethral injection of polyacrylamide hydrogel (Bulkamid^®) for the treatment of female stress urinary incontinence 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, přednosta prof. MUDr. A. Martan, DrSc.
Published in: Ceska Gynekol 2013; 78(6): 554-559
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 (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. 1^st 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 improproved) 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.

Keywords:
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. Hashim, H., Terry, TR. Management of recurrent stress urinary incontinence and urinary retention following midurethral sling insertion in women. Ann R Coll Surg Engl, 2012, 94(7), p. 517–522.

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

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

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

7. Koski, ME., Enemchukwu, EA., Padmanabhan, P., et al. Safety and efficacy of sling for persistent stress urinary incontinence after bulking injection. Urology, 2011, 77, p. 1076–1080.

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

9. Kuhn, A., Stadlmayr, W., Lengsfeld, D., Mueller, MD. Where should bulking agents for female urodynamic stress incontinence be injected? Int Urogynecol J, 2008, 19, p. 817–821.

10. 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.

11. 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.

12. 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.

13. 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.

14. 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.

15. 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.

16. Martan, A., Mašata, J., Švabík, K., et al. Změny léčebného efektu transuretrální aplikace polyakrylamid hydrogelu (Bulkamidu) při léčbě ženské stresové incontinence moči v závislosti na čase od operace. Čes Gynek, 2011, 76(6), s. 476–481.

17. Mohr, S., Siegenthaler, M., Mueller, MD., Kuhn, A. Bulking agents: an analysis of 500 cases and review of the literature. Int Urogynecol J, 2013, 24(2), p. 241–247.

18. 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.

19. Pradhan, A., Jain, P., Latthe, PM. Effectiveness of midurethral slings in recurrent stress urinary incontinence: a systematic review and meta-analysis. Int Urogynecol J, 2012, 23(7), p. 831–841.

20. Robinson, D., Anders, K., Cardoso, L., et al. What do women want? Interpretation of the concept of cure. J Pelvic Med Surg, 2003, 9, p. 273–277.

21. Sabadell, J., Poza, JL., Esgueva, A., et al. Usefulness of retropubic tape for recurrent stress incontinence after transobturator tape failure. Int Urogynecol J, 2011, 22(12), p. 1543–1547.

22. 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.

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

24. 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.

25. Toozs-Hobson, P., Al-Singary, W., Fynes, M., et al. Two-years follow-up of an open-label multicenter study of polyacrylamide hydrogel (Bulkamid^®) for female stress and stress-predominant mixed incontinence. Int Urogynecol J, 2012, 23(10), p. 1373–1378.

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