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

Eur J Obstet Gynecol Reprod Biol. 2016 Dec:207:68-72. doi: 10.1016/j.ejogrb.2016.10.011. Epub 2016 Oct 26.

Abstract

Objective: 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 0.5-1.25ccm 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.

Results: 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.

Conclusions: 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.

Keywords: Bulking agent; Midurethral sling; Minimally invasive procedure; Periurethral injections; Stress urinary incontinence.

Publication types

  • Clinical Study

MeSH terms

  • Aged
  • Combined Modality Therapy / adverse effects
  • Dimethylpolysiloxanes / administration & dosage
  • Dimethylpolysiloxanes / adverse effects
  • Dimethylpolysiloxanes / therapeutic use*
  • Drug Implants
  • Female
  • Follow-Up Studies
  • Humans
  • Intention to Treat Analysis
  • Lost to Follow-Up
  • Middle Aged
  • Obstetrics and Gynecology Department, Hospital
  • Parity
  • Poland / epidemiology
  • Postoperative Complications / epidemiology
  • Postoperative Complications / physiopathology
  • Postoperative Complications / prevention & control*
  • Risk
  • Secondary Prevention
  • Severity of Illness Index
  • Suburethral Slings / adverse effects
  • Tertiary Care Centers
  • Titanium / administration & dosage
  • Titanium / adverse effects
  • Titanium / therapeutic use*
  • Urethra / drug effects*
  • Urethra / physiopathology
  • Urinary Incontinence, Stress / drug therapy*
  • Urinary Incontinence, Stress / physiopathology
  • Urinary Incontinence, Stress / prevention & control
  • Urinary Incontinence, Stress / surgery
  • Urological Agents / administration & dosage
  • Urological Agents / adverse effects
  • Urological Agents / therapeutic use*

Substances

  • Dimethylpolysiloxanes
  • Drug Implants
  • Urological Agents
  • urolastic
  • Titanium