Study design, materials and methods
This was a retrospective cohort study complemented by a prospective telephone follow-up survey. We reviewed the records of 90 female patients who underwent Bulkamid injection for SUI or mixed urinary incontinence (MUI). The retrospective component involved analyzing medical records to collect data on demographics, obstetric history, type of incontinence, previous pelvic interventions, and procedural details including injection volume. A telephone follow-up survey was conducted at a minimum of six months post-procedure to assess long-term outcomes. A Validated questionnaire, developed by the research team was administered. This included domains addressing symptom recurrence, frequency and severity of leakage, impact on quality of life, retreatment, and patient satisfaction. the survey incorporate validated elements from the International Consultation on Incontinence Questionnaire (ICIQ)(1) to assess ongoing urinary leakage. Statistical analysis included descriptive statistics and correlation testing using Chi-square and t-tests to evaluate associations between patient characteristics and treatment outcomes.
Results
90 female patients who underwent Bulkamid injection for stress or mixed urinary incontinence were analyzed. The mean age was 47.3 years (SD 10.15) and BMI 28.2 (SD 4.05). The sample population was comprised of 60% local women. MUI was the predominant type (60%), and 22.2% had previous pelvic surgeries. The mean injection volume was 1.76 ml. Complications were reported in 9 patients (12.7%), including postoperative UTI in 3 patients and acute urinary retention in 7 patients. On follow up phone calls 6+ months after surgery, leakage persisted in 86.8% of patients, with 62.5% reporting small amounts and 25% large amounts. The mean interference with QOL was 6.92 (SD 3.48). Bulkamid was repeated in 37% of cases, and 15% required alternative interventions. Notably, 66.7% would recommend the procedure. No statistically significant correlations were found between complications or outcomes and age, BMI, number of pregnancies, or injection volume.
Interpretation of results
Bulkamid demonstrated a favourable safety profile with low complication rates, but a high percentage of patients continued to report urinary leakage after treatment. The lack of significant associations between baseline characteristics and outcomes suggests that patient selection criteria alone may not predict response to therapy. Despite symptom persistence, the majority of patients expressed satisfaction with the treatment, likely reflecting the minimally invasive nature, improvement in leakage, and safety of the procedure. These findings underscore the importance of individualized counselling and expectation management.