Nonabsorbable urethral bulking agent — clinical effectiveness and late complications rates in the treatment of recurrent stress urinary incontinence after 2 years of follow-up

Published:October 26, 2016DOI:



      Those patients who failed to achieve continence after a procedure aimed to correct it, require a special attitude and precise management due to the sophisticated anatomical and functional field of interest. The purpose of the present study was to assess long-term clinical efficacy and evaluate the frequency and severity of any complications related to recurrent stress urinary incontinence treatment with a non-absorbable bulking agent periurethral injections.

      Study design

      Between February 2012–September 2013, 66 patients with recurrent stress urinary incontinence were treated with Urolastic in the tertiary referral gynecologic department. The efficacy of the procedure was assessed objectively at each follow-up visit, scheduled at two, six weeks and 3, 6, 12 and 24 months after primary procedure. Material was injected under local anesthesia according to the manufacturer’s instructions, at 10, 2, 4 and 8 o’clock positions with 0.5–1.25 ccm per spot. Statistical analyses were performed with Statistica package version 8.0 (StatSoft Inc., Tulsa, OK, USA). A p value <0.05 was considered statistically significant.


      Objective success rate at 24 months was found in 32.7% of patients, including 22.4% patients who were completely dry. The efficacy of Urolastic, when considering the intention to treat, is 24.2% and 16.7%, respectively. In 4.5% patients an oval shaped material was found inside the bladder. Overall, complications were observed in 17 (25.8%) patients.


      Although only 30% of patients will benefit from Urolastic injection on the long-term basis it seems to be a safe procedure in the treatment of recurrent stress urinary incontinence.


      To read this article in full you will need to make a payment

      Purchase one-time access:

      Academic & Personal: 24 hour online accessCorporate R&D Professionals: 24 hour online access
      One-time access price info
      • For academic or personal research use, select 'Academic and Personal'
      • For corporate R&D use, select 'Corporate R&D Professionals'


        • Gamé X.
        • Khan S.
        • Panicker J.N.
        • et al.
        Comparison of the impact on health-related quality of life of repeated detrusor injections of botulinum toxin in patients with idiopathic or neurogenic detrusor overactivity.
        BJU Int. 2011; 107: 1786-1792
        • Chen S.F.
        • Kuo H.C.
        Therapeutic outcome and patient adherence to repeated onabotulinumtoxinA detrusor injections in chronic spinal cord-injured patients and neurogenic detrusor overactivity.
        J Formos Med Assoc. 2015; 114: 583-589
        • Rechberger T.
        • Futyma K.
        • Jankiewicz K.
        • et al.
        Tape fixation: an important surgical step to improve success rate of anti-incontinence surgery.
        J Urol. 2011; 186: 180-184
        • Novara G.
        • Artibani W.
        • Barber M.D.
        • et al.
        Updated systematic review and meta-analysis of the comparative data on colposuspensions, pubovaginal slings, and midurethral tapes in the surgical treatment of female stress urinary incontinence.
        Eur Urol. 2010; 58: 218-238
        • Nilsson C.G.
        • Palva K.
        • Aarnio R.
        • Morcos E.
        • Falconer C.
        Seventeen years’ follow-up of the tension-free vaginal tape procedure for female stress urinary incontinence.
        Int Urogynecol J Pelvic Floor Dysfunct. 2013; 24: 1265-1269
        • Reynolds W.S.
        • Dmochowski R.R.
        Urethral bulking: a urology perspective.
        Urol Clin North Am. 2012; 39: 279-287
        • Petros P.E.
        • Ulmsten U.I.
        The tethered vagina syndrome, post surgical incontinence and I-plasty operation for cure.
        Acta Obstet Gynecol Scand Suppl. 1990; 153: 63-67
        • Fabian G.
        • Barcz E.
        • Zwierzchowska A.
        • Kociszewski J.
        Complications of sub-urethral sling procedures.
        Ginekol Pol. 2014; 85: 536-540
        • Zajda J.
        • Farag F.
        Urolastic—a new bulking agent for the treatment of women with stress urinary incontinence: outcome of 12 months follow up.
        Adv Urol. 2013; 2013: 724082
        • Futyma K.
        • Miotła P.
        • Gałczyński K.
        • et al.
        An open multicenter study of clinical efficacy and safety of Urolastic, an injectable implant for the treatment of stress urinary incontinence: one-year observation.
        Biomed Res Int. 2015; 2015: 851823
        • Reed 3rd, T.P.
        Ovabloc. Five years of experience.
        J Reprod Med. 1984; 29: 601-602
        • Assaf A.
        • Abdin F.
        • Elkady A.
        • et al.
        Histopathological effects of silicone rubber ‘Ovabloc’ on the human fallopian tube.
        Int J Gynaecol Obstet. 1993; 43: 181-189
        • Stamey T.A.
        Urinary incontinence in the female: stress urinary incontinence.
        in: Harrison J.H. Gittes R.F. Perlmutter A.D. Campbell’s urology. 4th ed. WB Saunders, Philadelphia1979: 2272-2293
        • Keegan P.E.
        • Atiemo K.
        • Cody J.
        • et al.
        Periurethral injection therapy for urinary incontinence in women.
        Cochrane Database Syst Rev. 2007; 3 (CD003881. Update in: Cochrane Database Syst Rev 2012; 2: CD003881)
        • Ghoniem G.
        • Corcos J.
        • Comiter C.
        • Bernhard P.
        • Westney O.L.
        • Herschorn S.
        Cross-linked polydimethylsiloxane injection for female stress urinary incontinence: results of a multicenter, randomized, controlled, single-blind study.
        J Urol. 2009; 181: 204-210
        • Ghoniem G.
        • Corcos J.
        • Comiter C.
        • Westney O.L.
        • Herschorn S.
        Durability of urethral bulking agent injection for female stress urinary incontinence: 2-year multicenter study results.
        J Urol. 2010; 183: 1444-1449
        • Ghoniem G.M.
        • Miller C.J.
        A systematic review and meta-analysis of macroplastique for treating female stress urinary incontinence.
        Int Urogynecol J. 2013; 24: 27-36
        • Ligt-Veneman N.G.
        • Tinga D.J.
        • Kragt H.
        • Brandsma G.
        • van der Leij G.
        The efficacy of intratubal silicone in the Ovabloc hysteroscopic method of sterilization.
        Acta Obstet Gynecol Scand. 1999; 78: 824-825
        • Lee H.N.
        • Lee Y.S.
        • Han J.Y.
        • Jeong J.Y.
        • Choo M.S.
        • Lee K.S.
        Transurethral injection of bulking agent for treatment of failed mid-urethral sling procedures.
        Int Urogynecol J Pelvic Floor Dysfunct. 2010; 21: 1479-1483
        • Maher C.F.
        • O’Reilly B.A.
        • Dwyer P.L.
        • Carey M.P.
        • Cornish A.
        • Schluter P.
        Pubovaginal sling versus transurethral macroplastique for stress urinary incontinence and intrinsic sphincter deficiency: a prospective randomized controlled trial.
        BJOG. 2005; 112: 797-801