Seven-year efficacy and safety outcomes of Bulkamid for the treatment of stress urinary incontinence.

Abstract

AimsBulking agents are a minimally invasive treatment option for women with stress urinary incontinence (SUI) or stress‐predominant mixed urinary incontinence (MUI). The aim of this study was to evaluate long‐term efficacy and safety following treatment with Bulkamid as a primary procedure for SUI or stress‐predominant MUI.MethodsThis was an Institutional Review Board‐approved single‐center retrospective study of female patients with SUI or stress‐predominant MUI who had undergone injection with Bulkamid since 2005 and had completed 7 years of follow up. The primary endpoint was patient satisfaction measured on a four‐point scale as cured, improved, unchanged, or worse. Secondary outcomes included the number of incontinence pads used, International Consultation on Incontinence Questionnaire‐Short Form (ICIQ‐UI SF) scores, Visual Analog Scale Quality of Life (VAS QoL), reinjection rates, and perioperative and postoperative complications.ResultsA total of 1,200 patients were treated with Bulkamid since 2005 and of these, 388 (32.3%) had completed 7 years of follow‐up. A total of 67.1% of the patients reported feeling cured or improved if Bulkamid was a primary procedure, 11.1% reported no change, and 2.3% reported worsening of incontinence. A total of 19.5% of patients received a subsequent other incontinence procedure. The ICIQ‐UI SF was reduced by 8.6 points. VAS QoL improved by a mean of 4.3 points. Postoperative complications were transient. Prolonged bladder emptying time was reported in 15.3% of patients and urinary tract infection in 3.5%.ConclusionsBulkamid injections are an effective and safe first‐line treatment option for women with SUI or stress‐predominant MUI providing durable outcomes at 7 years.