Mid- to long-term results of Polyacrylamide Hydrogel (Bulkamid®) as recourse for female stress urinary incontinence

Abstract

Aim:We aimed to assess the mid- to long-term outcome of Polyacrylamide Hydrogel urethral injections as a treatment for women with stress urinary incontinence (SUI), who are not eligible for treatment with midurethral slings. Methods:We performed a single-arm, patient cohort study using the subjective improvement rate as primary outcome, defined as an answer “(very) much better” on the Patient Global Impression of Improvement. Secondary outcomes were the subjective cure rate (a negative answer to the Urogenital Distress Inventory stress subscale question 4), patient satisfaction (Visual Analogue Scale of ≥ 8.0), complication rate, the amount of Hydrogel injected, the number of reinjections and to what extent patients would recommend this treatment. Results:A total of 357 women with pure SUI, or mixed urinary incontinence with predominant SUI were included. Adverse events were retrieved from their patient records and all received a questionnaire, which was completed and returned by 153 (42.9%) women. After a median follow-up of two and a half years, the subjective improvement rate was 52.1%. The subjective cure rate was 30.9%. A satisfaction score of ≥ 8.0 was achieved in 48.6% of the patient group. Minor adverse events due to the procedure were reported in 21% of patients. No serious adverse events were noted. Conclusions:This study demonstrates that Polyacrylamide Hydrogel, even after a mid- to long-term follow-up, is a valuable treatment option for women with SUI, who are ineligible for midurethral sling surgery. No serious adverse events related to the procedure were reported during the follow-up period.