Results of an innovative bulking agent in patients with stress urinary incontinence who are not optimal candidates for mid‐urethral sling surgery

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Aims Primary outcome was to evaluate patients' satisfaction after being treated with bulk injection therapy polydimethylsiloxane Urolastic (PDMS‐U) for stress urinary incontinence (SUI). Secondary outcomes were: subjective cure, objective cure, severity of SUI symptoms, complications, reintervention rate, and disease‐specific quality of life. Furthermore, to determine if outcomes worsened during time‐after‐treatment (time‐frames: 0‐12, 13‐24, and ≥25 months). Methods In a cross‐sectional design, patients treated with PDMS‐U were recruited for hospital revisit. The primary outcome, patients' satisfaction, was assessed by the surgical satisfaction questionnaire. Subjective cure, objective cure, and severity of symptoms were assessed by the patients global impression of improvement, standardized cough stress test, and Sandvik severity scale, respectively. Medical charts and face‐to‐face interviews were used to determine complications and reinterventions. Results About 110 patients participated, 87 revisited the hospital. Median follow‐up was 25 months (interquartile range: 14;35 months). Patients' satisfaction rate was 51%. Subjective and objective cure were respectively 46% and 47%. Most prevalent complications were: urinary retention (22%), pain (15%), and dyspareunia (15%). Exposure and erosion occurred in 7% and 5%, respectively. Reintervention rate of reinjection and excision of bulk material was 6% and 18.0%, respectively. Objective cure significantly worsened during time‐after‐treatment (P = < .05). Conclusions About half of the patients being treated with PDMS‐U were satisfied and subjectively cured 2 years after treatment, although the majority still experienced symptoms of SUI. Most complications were mild and transient, however, in 18% excision of bulk material was indicated for severe or persistent complications such as pain, exposure, or erosion.

Section: Introductionmentioning

confidence: 99%

Patients' satisfaction and safety of bulk injection therapy Urolastic for treatment of stress urinary incontinence: A cross‐sectional study

Casteleijn

Kowalik

Berends

et al. 2020

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“…It's unique feature is that it polymerizes in situ into a uniform elastomer, remaining flexible and adapting itself to the environment. This is thought to reduce the risk of migration . In a clinical trial in the Netherlands, 76‐88% of the patients showed subjective improvement at 12‐25 months follow‐up …”

Section: Resultsmentioning

confidence: 99%

“…This is thought to reduce the risk of migration. 38,39 In a clinical trial in the Netherlands, 76-88% of the patients showed subjective improvement at 12-25 months follow-up. 40 In conclusion, although, there have been a number of studies conducted to look at the short-term efficacy, durability and safety of UBAs, in order to guide future practice, further comparative randomised trials involving a placebo or conservative treatment arm are required with long-term follow up.…”

Section: Discussionmentioning

confidence: 99%

Urethral bulking agents for female stress urinary incontinence

Hussain

Bray

2019

Urethral bulking agents (UBAs) to treat stress urinary incontinence was first described in the 1930s, when paraffin was used to increase urethral resistance. Since then, several agents have been introduced to the market, with varying degrees of safety, efficacy, and durability. The agents currently available include calcium hydroxyl apatite (Coaptite®), carbon coated zirconium (Durasphere®); polydimethylsiloxane elastomer (Macroplastique®); and polyacrylamide hydrogel (Bulkamid®). The latest product, PDMS‐U (Urolastic ®) is a silicone gel that polymerizes when injected. The short term efficacy of UBAs are generally encouraging; however, longer follow up results show the success rates are reduced and many women will require a repeat treatment. This review looks at the currently available UBAs, application techniques, and the clinical data on their safety and efficacy.

“…Randomized trials comparing UBA with MUS surgery are needed to determine if UBA treatment achieves cure rates of 79% or higher. Cohort studies of bulking agent Urolastic report results lower to this threshold with subjective and objective cure rates of 56% to 68% and 59% to 65%, respectively, after 6‐ and 12‐month follow‐up . A systematic review of other bulking agents show on the other hand subjective and objective success rates up to 89% and 73% …”

Section: Discussionmentioning

confidence: 99%

“…Cohort studies of bulking agent Urolastic report results lower to this threshold with subjective and objective cure rates of 56% to 68% and 59% to 65%, respectively, after 6-and 12-month follow-up. 4,7,24 A systematic review of other bulking agents show on the other hand subjective and objective success rates up to 89% and 73%. 8 There is no worldwide consensus about the exact place of UBA in current treatment protocols.…”

Section: Discussionmentioning

confidence: 99%

How cure rates drive patients' preference for urethral bulking agent or mid‐urethral sling surgery as therapy for stress urinary incontinence

Casteleijn

Enklaar

Bouyahyaoui

et al. 2019

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Aims To assess the patients' median‐accepted threshold of cure rate for urethral bulking agent (UBA) treatment compared to mid‐urethral sling (MUS) surgery for treatment of female stress urinary incontinence (SUI). Secondly, to determine the correlation between treatment trade‐off point and patient characteristics. Methods Women older than 18 years, with predominant SUI, seeking treatment, underwent a structured interview. The treatment trade‐off point was determined in scenario one: UBA vs transobturator standard MUS surgery (SMUS) performed under general/spinal anesthesia with one‐night hospital stay, and scenario 2: UBA compared to single‐incision MUS surgery (SIMS) performed under local analgesia (with sedation) in a daycare setting. The treatment trade‐off point was assessed by decreasing the cure rate of UBA from 85% to 10% with steps of 2% until the patient's treatment preference switched to SMUS/SIMS. Results One hundred and five patients were interviewed. Mean age was 52 years (SD, ±13.4). The median trade‐off point for scenarios 1 and 2 was 79% (interquartile range [IQR]: 69, 85) and 85% (IQR: 71, 85), respectively. Patients with longer duration of SUI symptoms were willing to trade more efficacy to prefer UBA treatment. Conclusions Patients with SUI are willing to trade a lower cure rate to prefer UBA over SMUS to avoid hospitalization and general anesthesia. When SIMS is performed in a daycare setting under local analgesia, the majority of patients with SUI are of the opinion that cure rates of UBA should be at least as high as SIMS to be worth considering. The treatment preference is not strongly correlated with the patients' characteristics.