Urethral bulking with Bulkamid: An analysis of efficacy, safety profile, and predictors of functional outcomes in a single‐center cohort

Abstract

Aims The aim of the present work is to analyze the safety profile, effectiveness, and favorable and unfavorable predictors of clinical outcome in urethral bulking with Bulkamid, and to better identify the ideal candidate for the procedure. Methods We included all consecutive female patients treated with urethral bulking with Bulkamid at our institution within 2 years. Patients were affected by stress urinary incontinence (SUI) or mixed incontinence. Incontinence severity was classified as “mild” (urinary leakage <50 g/die), “moderate” (50‐200 g/die), or “severe” (>200 g/die) at 24‐hours pad test. Clinical success was defined as “dry” (no pads); clinical failure included “partial improvement” (>50% 24‐hours pad test reduction) and “no benefit” (<50% 24‐hours pad test reduction). The χ2 and Mann‐Whitney tests were performed to assess the predictors of clinical outcome. Results The success rate was 36.1% (n = 35). Forty‐three patients (44.3%) reported continence improvement. Complications included eight urinary retention cases (8.2%). Statistically significant correlation was observed between incontinence severity and clinical outcome in thee χ2 test (P = .008). No significant correlation was found between functional outcome and urodynamic incontinence features, postoperative urinary retention, previous pelvic surgery, age, and other physiological, pathological, and urodynamics characteristics. Urinary retention following the surgical procedure appeared to be related to clinical success with nonsignificant P value (P = .10). Conclusions Bulkamid procedure could be proposed with good results in elderly patients or in patients requiring a low‐invasive procedure with low risk of complications, affected either by SUI or mixed incontinence and with mild to moderate incontinence. Previous training to clean intermittent self‐catheterization maneuver should be performed.

Combination therapy with botulinum toxin and bulking agent—An efficient, sustainable, and safe method to treat elderly women with mixed urinary incontinence

“…Twenty‐two percent of our patients had PAHG‐related postoperative urinary retention which followed complete spontaneous resolution within a few days of CIC. This was higher than in other studies that reported urinary retention rates of 5.7%, 23 1.1%, 9 1.9%, 7 13%, 15 or 8.2% 25 …”

“…This was higher than in other studies that reported urinary retention rates of 5.7%, 23 1.1%, 9 1.9%, 7 13%, 15 or 8.2%. 25 Mean PVR volume increase from baseline as a consequence of botulinum toxin injection were highest (+71 ml) at the 14-day visit, and decreased to +20 ml after 4 months. Other studies with 100 units of botulinum toxin reported similar kinetics, with a maximum increase after 2 weeks (+49.5 ml, 14 +50 ml, 24 +48.78 ml 19 ), and a decrease at 12 weeks (+32.6 ml, 14 +35 ml, 24 +15.53 ml 19 ).…”

Can urethral re-bulking improve the outcomes of a prior urethral bulking?

“… 1 – 3 The most appealing features both for patients and clinicians are the extreme simplicity of the surgical procedure and the very low incidence of peri-operative and long-term complications, which include self-limiting hematuria, temporary urinary retention and uncomplicated urinary tract infections. 2 …”

Urethral Bulking in the Treatment of Stress and Mixed Female Urinary Incontinence: Results from a Multicenter Cohort and Predictors of Clinical Outcomes

“…Nevertheless, its relative inferiority in terms of clinical outcomes when compared to mid-urethral slings (MUS) was clearly stated by several works [ 1 , 2 ]. In fact, according to literature, the dry rate of UB can range from 16% to 50% despite a high satisfaction rate (up to 80% according to some studies) [ 2 , 3 , 4 ]. Furthermore, it is still not clearly stated whether functional results can be persistent over time or if the procedure needs to be repeated in order to maintain its efficacy since results from several studies are contradictory [ 5 ].…”