Results of an innovative bulking agent in patients with stress urinary incontinence who are not optimal candidates for mid-urethral sling surgery

Aims: To 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.

Methods: A 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.

Results: Subjective 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.

Conclusions: PBI with PDMS-U is a viable treatment option in women with a relative contra-indication for mid-urethral sling surgery.