Results of an Innovative Bulking Agent in Patients with Stress Urinary Incontinence Who Are Not Optimal Candidates for Mid-Urethral Sling Surgery

AimsTo assess the efficacy and safety of peri‐urethral bulking injections (PBI) with an innovative bulking material (PDMS‐U) in women with stress‐urinary incontinence (SUI) who are not optimal candidates for mid‐urethral sling surgery.MethodsA prospective study was performed in women with SUI who, for several reasons, have a relative contraindication for a mid‐urethral sling procedure.These reasons include: (i) recurrent SUI after a prior SUI surgical procedure; (ii) a history of oncologic gynaecological surgery; (iii) a history of neurologic disease resulting in voiding problems; (iv) a maximal flow rate of less than 15 mL per second or; (v) women with a contraindication for surgery with general or regional anaesthesia. All women were treated with PBI consisting of PDMS‐U, a bulking agent that polymerizes in situ. The primary outcome was subjective improvement, defined as “a little better” to “very much better” on the PGI‐I. Secondary outcomes included objective cure, disease specific quality of life and adverse events.ResultsSubjective improvement was reported by 18 (90%) of the 20 included patients. The subjective cure rate was 56% and the objective cure rate was 65%. There was a statistically significant improvement of all domain scores of the UDI‐6, IIQ‐7, and PISQ‐12 at 6 months follow up. Abnormal post voiding residual volume (>150 mL) was the most common adverse event (40%), but persisted in only one patient, based on the patient's preference for a catheter.ConclusionsPBI with PDMS‐U is a viable treatment option in women with a relative contra‐indication for mid‐urethral sling surgery.