PROSPECTIVE OBSERVATIONAL STUDY OF THE TREATMENT OF URINARY INCONTINENCE USING BULKAMID® URETHRAL INJECTION

Riaza Montes M1, Palacios Ramos J1, López Salazar A1, Ambuila Facundo E1, Gallego Sánchez J1

Research Type

Clinical

Abstract Category

Female Stress Urinary Incontinence (SUI)

Abstract 511
Open Discussion ePosters
Scientific Open Discussion Session 19
Thursday 28th September 2023
13:15 - 13:20 (ePoster Station 3)
Exhibit Hall
Female Stress Urinary Incontinence Prospective Study Pad Test Questionnaire
1. Galdakao-Usansolo Hospital, Galdakao, Spain
Presenter
Links

Poster

Abstract

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.
Concluding message
Bulkamid® injection is a minimally invasive, safe, and high satisfaction rate treatment option for selected patients with stress-predominant urinary incontinence.
Figure 1 Table 1. Pre-treatment characteristics
References
  1. Brosche T, Kuhn A, Lobodasch K, Sokol ER. Seven-year efficacy and safety outcomes of Bulkamid for the treatment of stress urinary incontinence. Neurourol Urodyn. 2021 Jan;40(1):502-508.
  2. Hoe V, Haller B, Yao HH, O'Connell HE. Urethral bulking agents for the treatment of stress urinary incontinence in women: A systematic review. Neurourol Urodyn. 2021 Aug;40(6):1349-1388.
  3. Kasi AD, Pergialiotis V, Perrea DN, Khunda A, Doumouchtsis SK. Polyacrylamide hydrogel (Bulkamid®) for stress urinary incontinence in women: a systematic review of the literature. Int Urogynecol J. 2016 Mar;27(3):367-75.
Disclosures
Funding None. Clinical Trial No Subjects Human Ethics Committee COMITÉ ÉTICO HOSPITAL GALDAKAO-USANSOLO Helsinki Yes Informed Consent Yes
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