Injectable Biological Bulking Agent to Treat Stress Urinary Incontinence in Women: A Feasibility Pilot Study

Abstract

Background: Urinary incontinence mainly affects women regardless of age and, as it affects their quality of life, influences work, sex life and independence for activities of daily living. The treatment of stress urinary incontinence including urethral volume injection therapy can provide an intermediate option over non-surgical and surgical therapies. One of the mechanisms for stress continence depends on the effective coaptation of the urethra during the increase in intra-abdominal pressure. The bulking agents can be injected transurethral or periurethral retrogradely, using direct vision from a cystoscope. Purpose: To evaluate the feasibility and preliminary outcome performance of the bacterial polysaccharide gel used as biological bulking agent applied in female patients with stress urinary incontinence. Methods: A prospective clinical pilot study was performed, in a single institution, including female patients who were admitted to the urologic outpatient clinic with Stress Urinary Incontinence (SUI) without previous treatments and they were selected and underwent bulking agent procedure. The evaluation was performed at the time of enrollment and 6 months after treatment. The primary outcome was Quality of Life (QOL) using the ICIQ-SF Questionnaire. The amount of urine leakage measured by the 1-HOUR PAD-TEST was the second outcome. Results: Fifteen women (with an average age of 53 years) were submitted to the application of bacterial cellulose gel and she was analyzed. Only two patients presented unchanged incontinence. The study considered as primary outcome the improvement or disappearance of symptoms after six months of intervention. Post-intervention Quality of Life (QOL) questionnaire indicated that all of these patients related a better quality of life (62.5%). Through the PAD-test it was possible to observe a decrease in urinary leak of 85% comparing the results pre and post-intervention (BCA—Bacterial Cellulose Application) with p-value equal to 0.000009. Conclusions: The results of this pilot study suggest that the use of biological bulking agent is a promising approach to treat stress urinary incontinence in female patients. Trial registration: Registration number and date of registration should be instated in this section.