Patient Experience With Ambulatory Bulkamid Injection

INTRODUCTION: Stress urinary incontinence (SUI) is the involuntary loss of urine on effort, physical exertion, sneezing, or coughing. It is highly prevalent and has a significant impact on quality of life. Urethral bulking with polyacrylamide hydrogel (Bulkamid) provides a minimally invasive treatment option for SUI caused by intrinsic sphincter deficiency. It has been found to lead to long-term improvement in symptoms of stress urinary incontinence and has a low risk of adverse events. Procedures on both the bladder and uterus can be performed safely in an ambulatory setting. Furthermore, studies have shown that ambulatory cystoscopy, urodynamics, hysteroscopy, and intradetrusor onabotulinum toxin A injection without sedation are generally well tolerated by patients. Although numerous studies have shown the safety and efficacy of Bulkamid injection when performed in both the ambulatory and intraoperative settings, there is limited data assessing patient pain and satisfaction with ambulatory Bulkamid injection. OBJECTIVE: The objective of this study was to compare anticipated and experienced pain with ambulatory Bulkamid injection without sedation. This study also assessed patient satisfaction with the procedure performed in an ambulatory setting. METHODS: This prospective study included patients undergoing ambulatory Bulkamid injection in a single urogynecology clinic with institutional review board approval. Before the procedure, patients completed a visual analog scale (VAS) rating their anticipated pain. Procedures were performed per standard clinic protocol with intravesical and intraurethral lidocaine. Following the procedure, patients completed an identical VAS documenting their experienced pain. Within one week, participants were contacted via phone and asked if they would repeat the procedure in an ambulatory setting if needed. Chart review was also performed. Anticipated and experienced pain scores were compared using Wilcoxon signed-rank test. RESULTS: Twenty-four participants agreed to participate in the study. Participants had an average age of 55.7 years and body mass index of 34.1. Most participants had not undergone a urogynecologic procedure in the past. Sixty percent of participants experienced mixed urinary incontinence symptoms. The average pre- and post-procedure VAS scores were 5.66 (SD 2.44) and 7.42 (SD 2.12), respectively. The average difference in scores was 1.76 (SD 2.34, p=0.001). Fifty percent of patients reported satisfaction with the procedure in the ambulatory setting. There was no statistically significant difference in the change in VAS score based on void trial results or willingness to undergo ambulatory procedure again. CONCLUSIONS: Participants reported higher-than-anticipated discomfort with ambulatory Bulkamid, yet most were satisfied and would repeat the procedure in an ambulatory setting. This study shows that ambulatory Bulkamid is feasible and well-accepted by patients. It also demonstrated that patients experienced more pain than they anticipated. Performing this procedure in the ambulatory setting without sedation allows for more widespread use, reduces risk for poor surgical candidates, conserves limited operating room time, and lowers patient costs. If greater emphasis is placed on setting pain expectations preoperatively, patient experience with and selection of ambulatory procedure may further improve.Table 1Table 2