Transurethral Injection of Polyacrylamide Hydrogel (Bulkamid^®) for the Treatment of Recurrent Stress Urinary Incontinence after Failed Tape Surgery

Česká verzia

Authors: A. Martan ¹ ; J. Mašata ¹; K. Švabík ¹; R. El-Haddad ¹; P. Hubka ¹ ; J. Krhut ²
Authors place of work: Gynekologicko-porodnická klinika 1. LF UK a VFN, Praha, přednosta prof. MUDr. A. Martan, DrSc. ¹; Urologická klinika, Univerzita Ostrava, přednosta doc. MUDr. J. Krhut, CSc. ²
Published in the journal: Ceska Gynekol 2015; 80(1): 25-29

Summary

Objective:
The objective of this study was to evaluate the cure effect of a transurethral injection of Bulkamid^® for recurrent female stress and mixed urinary incontinence in women who had undergone failed tape surgery. Our hypothesis was that cure effect of Bulkamid^® is positive in patients when previous tape anti-incontinence surgery has been unsuccessful.

Design:
Retrospective clinical study.

Settings:
Department of Obstetrics and Gynecology, 1st Medical Faculty, Charles University and General Faculty Hospital in Prague

Materials and methods:
This retrospective study featured 34 patients with recurrent urinary incontinence (SUI: 28, mixed: 6 – predominant symptom was SUI) after unsuccessful tape anti-incontinence surgery. 25 of the patients had undergone anti-incontinence surgery more than once. The cure effect of a transurethral injection of Bulkamid^® was evaluated an average of 29 months after the surgery; the minimum period after surgery was 6 months. 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 after surgery. An 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:
The mean age of patients was 71.03 years, mean body mass index (BMI) 29.12 and mean parity 1.91. The cough test showed that 4/34 (11.8%) of patients had negative results for this test after the operation. The ICIQ-UI SF questionnaire showed that 14/34 (41.2%) of our patients were dry or improved after surgery. The mean VAS score was 62.4 after the operation. The Likert score was 4 or 5 (cured or improved) after the operation for 88.2% of patients.

Conclusions:
Our hypothesis that the cure effect of Bulkamid^® operation would be positive in patients who have undergone previous unsuccessful tape anti-incontinence surgery was partially confirmed. The Likert and VAS scores indicate that the effect of Bulkamid^® surgery is good; however, an evaluation of the cure effect of this procedure based on the ICIQ-UI SF score is less positive. This kind of operation, which is minimally invasive, is less arduous for patients, and it is also suitable for patients who have refused further surgical treatment.

Keywords:
female stress urinary incontinence,anti-incontinence surgery, Bulkamid^®

Zdroje

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. Davis, NF., Kheradmand, F., Creagh, T. Injectable biomaterials for the treatment of stress urinary incontinence: their potential and pitfalls as urethral bulking agents. Int Urogynecol J, 2013, 24, p. 913–919.

4. 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.

5. Christensen, LH., Nielsen, JB., Mouritsen, L., et al. Tissue integration of polyacrylamide hydrogel: an experimental study of periurethral, perivesical, and mammary gland tissue in the pig. Dermatol Surg, 2008, 34 Suppl. 1, p. 68–77.

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

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

8. 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.

9. 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.

10. 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.

11. Lose, G., Grifiths, DJ., Hosker, G., et al. Standardisation of urethral pressure measurement: report of the sub-committee of the International Continence Society. Neurourol Urodyn, 2002, 21, p. 258–260.

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. 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.

15. Martan, A., Mašata, J., Švabík, K., Krhut, J. Transurethral injection of polyacrylamide hydrogel (Bulkamid^®) for the treatment of female stress or mixed urinary incontinence. Eur J Obst &Gyn and Reproductive Biology, 2014,178, p. 199–202.

16. Mohr, S., Siegenthaler, M., Mueller, MD., Kuhn, A. Bulking agents: an analysis of 500 cases and review of the literature. Int Urogynecol J, 2012, 24, p. 241–247.

17. 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.

18. 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.

19. 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.

20. 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.

21. Schaefer, W., Abrams, P., Liao, L., et al. Good urodynamic practices, uroflowmetry, filling, cystometry, and pressure-flow studies. Neurourol Urodyn, 2002, 21, p. 261–274.

22. Sokol, ER., Karram, MM., Dmochowski, R. Efficacy and safety of Bulkamid^® in the treatment of female stress incontinence: A randomized, prospective multicenter North-American study.J Urol, 2014, 10.1016/j.juro.2014.03.109.

23. 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.

24. Vecchioli-Scaldazza, C., Morosetti, C., Azizi, B., et al. Polyacrylamide hydrogel (Bulkamid^®) in female patients of 80 or more years with urinary incontinence. Int Brazil J Urol, 2014, 40, p. 37–43.