Top

International Urogynecology Journal

Published in:

01-02-2013 | Original Article

Bulking agents: an analysis of 500 cases and review of the literature

Authors: Stefan Mohr, Martine Siegenthaler, Michael D. Mueller, Annette Kuhn

Published in: International Urogynecology Journal | Issue 2/2013

Abstract

Introduction and hypothesis

Stress urinary incontinence (SUI) is common, impacts women’s quality of life, and generates high costs. Physiotherapy is the first-line therapy, and if it fails, suburethral slings are the gold standard in SUI surgery. Bulking agents injected periurethrally might be a beneficial alternative, but there is a paucity of data on bulking therapy. The aim of this study was to prospectively analyze the efficacy and safety of bulking agents in the setting of a tertiary referral center.

Methods

In the last 13 years, 514 elderly women with SUI were treated by injection therapy with either collagen (Contigen®), hyaluronic acid (Zuidex®), ethylene vinyl alcohol (Tegress®), or polyacrylamide hydrogel (Bulkamid®). Subjective and objective outcome was recorded at the 12-month postoperative appointment using the King’s Health Questionnaire, visual analogue scale (VAS) describing their incontinence severity, standardized pad test, and urethral pressure profile.

Results

Demographic data were equally distributed in all four groups of agents used. Sixty-one patients were lost to follow-up (10.6 %). Statistically significant changes were found for maximum urethral closure pressure (MUCP), pad weight, and VAS before and after bulking for the four agents used. Pad test was negative in 73.2 % of patients after bulking therapy. Subjective assessment showed improvements in general health and role limitations. The overall complication rate was low for all agents.

Conclusions

This study shows improvement in incontinence after bulking therapy according to subjective and objective outcomes in an elderly population. In contrast to earlier reports, side effects due to injections were few and mild. We can advocate bulking therapy for treating SUI, as it is simple, safe, and shows both objective and subjective improvement and relief.

Blaivas JG, Appell RA, Fantl JA, Leach G, McGuire EJ, Resnick NM et al (1997) Definition and classification of urinary incontinence: recommendations of the urodynamic society. Neurourol Urodyn 16:149–151PubMedCrossRef

Abrams P, Cardozo L, Fall M, Griffiths D, Rosier P, Ulmsten U et al (2003) The standardisation of terminology in lower urinary tract function: report from the standardisation sub-committee of the international continence society. Urology 61:37–49PubMedCrossRef

Mohr S, Kuhn P, Mueller MD, Kuhn A (2011) Painful love-"hispareunia" after sling erosion of the female partner. J Sex Med 8:1740–1746PubMedCrossRef

Kerr LA (2005) Bulking agents in the treatment of stress urinary incontinence: history, outcomes, patient populations, and reimbursement profile. Rev Urol 7(Suppl 1):S3–S11PubMed

Papanicolaou S, Pons ME, Hampel C, Monz B, Quail D, Schulenburg MG et al (2005) Medical resource utilisation and cost of care for women seeking treatment for urinary incontinence in an outpatient setting. Examples from three countries participating in the PURE study. Maturitas 52(Suppl 2):S35–S47PubMedCrossRef

Shamliyan TA, Kane RL, Wyman J, Wilt TJ (2008) Systematic review: randomized, controlled trials of nonsurgical treatments for urinary incontinence in women. Ann Intern Med 148:459–473PubMed

Serati M, Salvatore S, Uccella S, Artibani W, Novara G, Cardozo L et al (2009) Surgical treatment for female stress urinary incontinence: what is the gold-standard procedure? Int Urogynecol J Pelvic Floor Dysfunct 20:619–621PubMedCrossRef

Davila GW (2011) Nonsurgical outpatient therapies for the management of female stress urinary incontinence: long-term effectiveness and durability. Adv Urol 2011:176498PubMed

Sassani P, Aboseif SR (2009) Stress urinary incontinence in women. Curr Urol Rep 10:333–337PubMedCrossRef

10.

Keegan PE, Atiemo K, Cody J, McClinton S, Pickard R (2007) Periurethral injection therapy for urinary incontinence in women. Cochrane Database Syst Rev CD003881

11.

Chapple CR, Wein AJ, Brubaker L, Dmochowski R, Pons ME, Haab F et al (2005) Stress incontinence injection therapy: what is best for our patients? Eur Urol 48:552–565PubMedCrossRef

12.

Plotti F, Zullo MA, Sansone M, Calcagno M, Bellati F, Angioli R et al (2009) Post radical hysterectomy urinary incontinence: a prospective study of transurethral bulking agents injection. Gynecol Oncol 112:90–94PubMedCrossRef

13.

McGuire EJ (2006) Urethral bulking agents. Nat Clin Pract Urol 3:234–235PubMedCrossRef

14.

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

15.

Lose G, Sorensen HC, Axelsen SM, Falconer C, Lobodasch K, Safwat T (2010) An open multicenter study of polyacrylamide hydrogel (Bulkamid(R)) for female stress and mixed urinary incontinence. Int Urogynecol J 21:1471–1477PubMedCrossRef

16.

ter Meulen PH, Berghmans LC, Nieman FH, van Kerrebroeck PE (2009) Effects of macroplastique implantation system for stress urinary incontinence and urethral hypermobility in women. Int Urogynecol J Pelvic Floor Dysfunct 20:177–183PubMedCrossRef

17.

Kelleher CJ, Cardozo LD, Khullar V, Salvatore S (1997) A new questionnaire to assess the quality of life of urinary incontinent women. Br J Obstet Gynaecol 104:1374–1379PubMedCrossRef

18.

Bjelic-Radisic V, Dorfer M, Tamussino K, Greimel E (2005) Psychometric properties and validation of the German-language King's Health Questionnaire in women with stress urinary incontinence. Neurourol Urodyn 24:63–68PubMedCrossRef

19.

Zhang XH, Xie F, Wee HL, Thumboo J, Li SC (2008) Applying the expectancy-value model to understand health values. Value Health 11(Suppl 1):S61–S68PubMedCrossRef

20.

Ryhammer AM, Djurhuus JC, Laurberg S (1999) Pad testing in incontinent women: a review. Int Urogynecol J Pelvic Floor Dysfunct 10:111–115PubMedCrossRef

21.

Lightner D, Rovner E, Corcos J, Payne C, Brubaker L, Drutz H et al (2009) Randomized controlled multisite trial of injected bulking agents for women with intrinsic sphincter deficiency: mid-urethral injection of Zuidex via the Implacer versus proximal urethral injection of Contigen cystoscopically. Urology 74:771–775PubMedCrossRef

22.

Kuhn A, Stadlmayr W, Sohail A, Monga A (2008) Long-term results and patients' satisfaction after transurethral ethylene vinyl alcohol (Tegress) injections: a two-centre study. Int Urogynecol J Pelvic Floor Dysfunct 19:503–507PubMedCrossRef

23.

Koski ME, Enemchukwu EA, Padmanabhan P, Kaufman MR, Scarpero HM, Dmochowski RR (2011) Safety and efficacy of sling for persistent stress urinary incontinence after bulking injection. Urology 77:1076–1080PubMedCrossRef

24.

Lee HN, Lee YS, Han JY, Jeong JY, Choo MS, Lee KS (2010) Transurethral injection of bulking agent for treatment of failed mid-urethral sling procedures. Int Urogynecol J 21:1479–1483PubMedCrossRef

25.

Pickard R, Reaper J, Wyness L, Cody DJ, McClinton S, N'Dow J (2003) Periurethral injection therapy for urinary incontinence in women. Cochrane Database Syst Rev CD003881

26.

Klarskov N, Lose G (2008) Urethral injection therapy: what is the mechanism of action? Neurourol Urodyn 27:789–792PubMedCrossRef

27.

Gorton E, Stanton S, Monga A, Wiskind AK, Lentz GM, Bland DR (1999) Periurethral collagen injection: a long-term follow-up study. BJU Int 84:966–971PubMedCrossRef

28.

van KP, ter MF, Farrelly E, Larsson G, Edwall L, Fianu-Jonasson A (2003) Treatment of stress urinary incontinence: recent developments in the role of urethral injection. Urol Res 30:356–362

29.

Kuhn A, Stadlmayr W, Lengsfeld D, Mueller MD (2008) Where should bulking agents for female urodynamic stress incontinence be injected? Int Urogynecol J Pelvic Floor Dysfunct 19:817–821PubMedCrossRef

30.

Sharifi-Aghdas F (2005) Surgical management of stress urinary incontinence. Urol J 2:175–182PubMed

31.

Monga AK, Robinson D, Stanton SL (1995) Periurethral collagen injections for genuine stress incontinence: a 2-year follow-up. Br J Urol 76:156–160PubMedCrossRef

32.

Lightner D, Calvosa C, Andersen R, Klimberg I, Brito CG, Snyder J et al (2001) A new injectable bulking agent for treatment of stress urinary incontinence: results of a multicenter, randomized, controlled, double-blind study of Durasphere. Urology 58:12–15PubMedCrossRef

33.

Mayer RD, Dmochowski RR, Appell RA, Sand PK, Klimberg IW, Jacoby K et al (2007) Multicenter prospective randomized 52-week trial of calcium hydroxylapatite versus bovine dermal collagen for treatment of stress urinary incontinence. Urology 69:876–880PubMedCrossRef

34.

Bano F, Barrington JW, Dyer R (2005) Comparison between porcine dermal implant (Permacol) and silicone injection (Macroplastique) for urodynamic stress incontinence. Int Urogynecol J Pelvic Floor Dysfunct 16:147–150PubMedCrossRef

35.

Ghoniem G, Corcos J, Comiter C, Bernhard P, Westney OL, Herschorn S (2009) Cross-linked polydimethylsiloxane injection for female stress urinary incontinence: results of a multicenter, randomized, controlled, single-blind study. J Urol 181:204–210PubMedCrossRef

36.

Ghoniem G, Corcos J, Comiter C, Westney OL, Herschorn S (2010) Durability of urethral bulking agent injection for female stress urinary incontinence: 2-year multicenter study results. J Urol 183:1444–1449PubMedCrossRef

37.

Mazouni C, Bladou F, Karsenty G, Giorgi R, Andre M, Serment G (2004) Minimally invasive surgery for female urinary incontinence: experience with periurethral microballoon implantation. J Endourol 18:901–905PubMedCrossRef

38.

Lose G, Mouritsen L, Nielsen JB (2006) A new bulking agent (polyacrylamide hydrogel) for treating stress urinary incontinence in women. BJU Int 98:100–104PubMedCrossRef

39.

Lottmann HB, Margaryan M, Lortat-Jacob S, Bernuy M, Lackgren G (2006) Long-term effects of dextranomer endoscopic injections for the treatment of urinary incontinence: an update of a prospective study of 61 patients. J Urol 176:1762–1766PubMedCrossRef

40.

Lottmann HB, Margaryan M, Bernuy M, Grosz A, Aigrain Y, Lortat-Jacob S et al (2006) Long-term effects of dextranomer endoscopic injections for treatment of urinary incontinence: an update of a prospective study of 31 patients. J Urol 175:1485–1489PubMedCrossRef

41.

Tsai CC, Lin V, Tang L (2006) Injectable biomaterials for incontinence and vesico-ureteral reflux: current status and future promise. J Biomed Mater Res B Appl Biomater 77:171–178PubMed

42.

Palma PC, Riccetto CL, Martins MH, Herrmann V, de FR, Billis A et al (2006) Massive prolapse of the urethral mucosa following periurethral injection of calcium hydroxylapatite for stress urinary incontinence. Int Urogynecol J Pelvic Floor Dysfunct 17:670–671PubMedCrossRef

43.

Kumar D, Kaufman MR, Dmochowski RR (2011) Case reports: periurethral bulking agents and presumed urethral diverticula. Int Urogynecol J 22:1039–1043PubMedCrossRef

44.

Madjar S, Sharma AK, Waltzer WC, Frischer Z, Secrest CL (2006) Periurethral mass formations following bulking agent injection for the treatment of urinary incontinence. J Urol 175:1408–1410PubMedCrossRef

45.

Sweat SD, Lightner DJ (1999) Complications of sterile abscess formation and pulmonary embolism following periurethral bulking agents. J Urol 161:93–96PubMedCrossRef

46.

Hartanto VH, Lightner DJ, Nitti VW (2003) Endoscopic evacuation of Durasphere. Urology 62:135–137PubMedCrossRef

47.

Kreder KJ, Austin JC (1996) Treatment of stress urinary incontinence in women with urethral hypermobility and intrinsic sphincter deficiency. J Urol 156:1995–1998PubMedCrossRef

Title: Bulking agents: an analysis of 500 cases and review of the literature
Authors: Stefan Mohr
Martine Siegenthaler
Michael D. Mueller
Annette Kuhn
Publication date: 01-02-2013
Publisher: Springer-Verlag
Published in: International Urogynecology Journal / Issue 2/2013
Print ISSN: 0937-3462
Electronic ISSN: 1433-3023
DOI: https://doi.org/10.1007/s00192-012-1834-8

Keynote webinar | Spotlight on sleep in brain health

Springer Medicine

Bulking agents: an analysis of 500 cases and review of the literature

Abstract

Introduction and hypothesis

Methods

Results

Conclusions

Keynote webinar | Spotlight on sleep in brain health

Springer Medicine

Abstract

Introduction and hypothesis

Methods

Results

Conclusions

Please log in to get access to this content

Other articles of this Issue 2/2013

Urogynecology digest

Changes in urinary nerve growth factor and prostaglandin E2 in women with overactive bladder after anticholinergics

Vaginal invagination: definition, clinical presentation and surgical management

Pelvic floor muscle tenderness in asymptomatic, nulliparous women: topographical distribution and reliability of a visual analogue scale

Utility of clinical parameters, cystourethroscopy, and magnetic resonance imaging in the preoperative diagnosis of urethral diverticula

Postoperative management and restrictions for female pelvic surgery: a systematic review