ABSTRACT

Objective:

assessment the long term clinical effectiveness of the Opsys® bulking agent used as injectable therapy in the treatment of female stress urinary incontinence (SUI).

Patients and Method:

a total of 38 women with SUI were prospectively included in this non-randomized, open, multicenter study after having signed an informed consent form. The subjects’ mean age was 62.6 years, and the mean body mass index (BMI) was 31.8 kg/m2. One woman was lost to follow-up 12 months postoperatively. The preoperative evaluation included a physical examination, a 24-hour pad weight test (PWT), a Q-Tip test, Valsalva leak point pressure (VLPP) with urodynamic studies and the International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF1). Patients were followed-up for a total of 60 months, and these results were compared to those obtained at 12 months. Thirty-three patients (86.8%) underwent a single implant procedure, the remaining five cases (13.2%) received a second implantation.

Results:

Sixty months after surgery, the 24-hour PWT showed 46% of patients being dry, 27% improved, and 27% failed producing a 73% cure rate (dry+improved). The ICIQ-SF at 60 months showed a mean value of 10.1 (SD=6.2) compared to the preoperative mean value of 18.0 (SD=2.4). Nine patients (23.7%) presented with de novo urge incontinence, and 7 (18.4%) had transient urinary retention. Urinary tract infections (UTI) were confirmed in 3 cases (7.4%) and dysuria in 4 (10.5%).

Conclusions:

Opsys can be offered as a minimally invasive procedure with durable clinical results.