Patients' satisfaction and safety of bulk injection therapy Urolastic for treatment of stress urinary incontinence: A cross-sectional study

Aims: Primary outcome was to evaluate patients' satisfaction after being treated with bulk injection therapy polydimethylsiloxane Urolastic (PDMS-U) for stress urinary incontinence (SUI). Secondary outcomes were: subjective cure, objective cure, severity of SUI symptoms, complications, reintervention rate, and disease-specific quality of life. Furthermore, to determine if outcomes worsened during time-after-treatment (time-frames: 0-12, 13-24, and ≥25 months). Methods: In a cross-sectional design, patients treated with PDMS-U were recruited for hospital revisit. The primary outcome, patients' satisfaction, was assessed by the surgical satisfaction questionnaire. Subjective cure, objective cure, and severity of symptoms were assessed by the patients global impression of improvement, standardized cough stress test, and Sandvik severity scale, respectively. Medical charts and face-to-face interviews were used to determine complications and reinterventions. Results: About 110 patients participated, 87 revisited the hospital. Median follow-up was 25 months (interquartile range: 14;35 months). Patients' satisfaction rate was 51%. Subjective and objective cure were respectively 46% and 47%. Most prevalent complications were: urinary retention (22%), pain (15%), and dyspareunia (15%). Exposure and erosion occurred in 7% and 5%, respectively. Reintervention rate of reinjection and excision of bulk material was 6% and 18.0%, respectively. Objective cure significantly worsened during time-after-treatment (P = <.05). Conclusions: About half of the patients being treated with PDMS-U were satisfied and subjectively cured 2 years after treatment, although the majority still experienced symptoms of SUI. Most complications were mild and transient, however, in 18% excision of bulk material was indicated for severe or persistent complications such as pain, exposure, or erosion.