Hypothesis / aims of study
Periurethral injection of the Bulkamid® agent, a polyacrylamide hydrogel, has been a breakthrough in the treatment of Stress Urinary Incontinence (SUI) in female patients.
The objective is to analyze our results and evaluate the quality of life of the patients treated with Bulkamid® agent.
Study design, materials and methods
Prospective observational analysis of a serie of 27 female patients with SUI and 26 with stress-predominant Mixed Urinary Incontinence (MUI) treated with Bulkamid® periurethral injection at our center between 2019 and 2022. All patients had a previous urine culture. The procedure was performed by 2-3 periurethral injections with a 23G x 120 mm needle with <0.8 mm per injection at 0.5 - 1 cm from the bladder neck. Follow-up was performed with flowmetry, 24-hour pad weight test (24h-Pad Test) and the International Consultation on Incontinence Questionnaire Short Form (ICIQ-UI SF) for a median of 10 months (1 - 40).
Results
We analyzed 53 patients with a median age of 63 years (32-83) and BMI of 27 kg/m2 (19.23-35.6) (Table 1). The immediate postoperative adverse effects were urinary tract infection (Clavien II, 1.9%) and acute urinary retention (Clavien II, 3.8%). Regarding the late ones, 11.3% presented de novo urgency UI and 3.8%, two patients, persistence of SUI requiring repetition of Bulkamid® at 8 and 23 months respectively.
Control flowmetry revealed a mean Qmax 22 mL/s and post-void residual 24 mL. 24h-Pad Test showed a subjective satisfaction of "being dry" of 77.6% with a median of 10 months (1-40), with 30.2% of patients using 1 pad/day for security and 7.5% using 1 pad/day. Average "dry time" is 12.5 months. Quality of life was assessed with the ICIQ-UI SF questionnaire with a mean of 5.
Interpretation of results
Our study shows that this injectable agent present low rate of complicationes in the postoperative period. With regard to the persistence of SUI, Bulkamid® injection was required in only two patients with a good response.
A point to be highlighted is the average "dry time" after Bulkamid® injection is 14 months with mild urine leakage and the subjective satisfaction of "being dry" is high (4 % of patients are dry at 3 years).
Bulkamid injection appears to be an alternative treatment for stress-predominant urinary incontinence in selected patients. However further long-term studies and prospective trial comparing suburethral meshes with injectable agents are needed to answer the question if there are clear factors favoring one of them in this distinct patient population.