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Successful management of stress urinary incontinence with Contino® after radical prostatectomy: A case report

| Categories: Male Urethral Inserts , Urethral Inserts for Stress Incontinence , Bladder Leakage Control Device , Life360 Innovations , Men's Urinary Incontinence Protection , Contino® , Incontinence Control Device , Bladder Leak Protection , Urinary Incontinence Device for Men , Male Incontinence Product , Urine Leakage Control Product , Urine Leakage in Men , diaperalternative

Successful management of stress urinary incontinence with Contino® after radical prostatectomy: A case report

May 25, 2022

Abstract
Stress urinary incontinence (SUI) is highly prevalent and is a main side effect of radical prostatectomies (RP). SUI may have significantly negative side effects such as mental illness or reduced quality of life. Though surgical and non-surgical interventions are available, some patients have exhausted all avenues yet are not able to find adequate treatment and long-term management. This case report describes a 60-year-old male who experienced SUI after RP and did not find relief with periurethral Pro-ACT balloons, even after surgical repair. After being enrolled to participate in a trial for the Contino® urethral insert, he found significant and effective symptom management with the self-administered, non-surgical, class II medical device. His International Consultation on Incontinence Questionnaire (ICIQ) score significantly improved post-Contino® usage, and now reports no pain, leakage, or discomfort. Contino® may serve as an alternative treatment option for men with SUI.

Introduction
Stress urinary incontinence (SUI) is a main post-operative side effect of radical prostatectomies (RP) (1). Prevalence of SUI ranges from four percent to seventy percent post-RP (2–4). This wide range may result from the tendency of UI to be significantly underreported to practitioners due to associated stigma, fear of invasive surgical procedures, and poor awareness of treatment (5–7). There is some variability in the definition of incontinence, which leads to inconsistent diagnosis and treatment guidelines (8). Management and proper treatment of UI are of high importance, given the frequently reported psychological distress and decreased quality of life that results from inadequate incontinence management (9–13).
Though conservative treatments such as lifestyle interventions, pelvic floor muscle training, and scheduled voiding and bladder training are recommended as first-line treatments, the gold standard therapy for SUI post-RP remains as artificial urinary sphincter (AUS) implantation. No approved pharmacological intervention exists (14). In reality, only six to nine percent of patients who seek treatment for SUI opt for surgical intervention (15) due to the invasiveness, complexity, and long-term complications (16,17). Additionally, AUS may involve additional follow-up procedures and infections (18,19). Adjustable continence therapy (ProACT) is a less invasive treatment option for patients (17), which involves two silicone balloons placed just distal to the bladder neck. One recent meta-analysis reported a dry rate of 60.2 percent and an improvement rate of 81.2 percent, though complication and revision rates were higher than rates reported for slings (17). Bladder or urethral perforation is the most commonly reported side effect, with rates of 5.3 percent across studies (17). Not all patients are eligible for these treatments, and in practice, some patients exhaust all available treatments yet struggle to find adequate treatment or relief, resorting to adult diapers with no permanent solution (20).
Here we report a 60-year-old male experiencing SUI as a result of a radical prostatectomy who found significant symptom relief with the usage of Contino®, a non-surgical, self-administered, urethral insert that temporarily blocks the flow of urine. Contino® is a licensed Class II medical device in Canada, with its safety and efficacy demonstrated through a five-year multi-site clinical trial (21).

Case Report
A healthy 60-year-old male was first diagnosed with prostate cancer in July of 2005 and underwent a radical prostatectomy three months later. There was no cancer recurrence, with no other underlying medical conditions. The patient experienced SUI post-RP, which was managed with multiple pads daily for over two years. He reported a significant reduction in quality of life, highlighting considerable embarrassment from pad leakage in social settings.


After years of unresolved SUI, the patient was referred to an incontinence-focused urologist who offered several options for medical device intervention, one of which was periurethral Pro-ACT balloons. The patient opted for Pro-ACT, given its less invasive nature compared to surgical treatments, and they were implanted in the fall of 2008. The patient found discomfort and limited effectiveness with Pro-ACT. Surgically repairing the balloons was unsuccessful, and they were permanently explanted in 2014.


In late 2014, the patient was offered to enroll in Contino®’s clinical study, which he completed in mid-2015. At baseline, his score on the International Consultation on Incontinence Questionnaire (ICIQ), a validated scale that evaluates the symptoms of urinary incontinence (22), was 14. Post-trial, with Contino® usage, his score significantly reduced to a 4, a meaningful decrease as interpreted by the FDA (23). He continues to use Contino® in the present day with no complications or adverse events that required medical intervention.
The patient no longer requires the use of pads and his subjective assessment of the reduction of his urine leakage is 98%. He has returned to regular exercise and reports that his previously deteriorated urge reflex is returning over time with continued use of Contino®.

Discussion and Conclusion

Incontinence is highly prevalent (2,3,6,24). There is currently no pharmacological treatment approved by the Food and Drug Administration (FDA) for the treatment of SUI. Compounds such as alpha-adrenoceptor agonists, beta-2 adrenoceptor agonists, and serotonin-noradrenaline reuptake inhibitors (e.g., duloxetine) have been investigated in small studies (14), though they are not recommended. Surgical interventions include artificial urinary sphincters, male slings, and periurethral balloons, though some patients are unwilling to consider invasive methods, or have comorbidities that preclude them from operations. A recent meta-analysis that analyzed the benefits and harms of surgical intervention for postprostatectomy urinary incontinence concluded that the available evidence remains mainly uncertain while suggesting important harms (20). Non-surgical treatment options include behavioral modification, absorption products, penile compressive devices, and condom catheters. However, not all treatments are satisfactory, appropriate for all lifestyles, and can include limitations such as frequent UTIs. Furthermore, some patients exhaust all available options yet struggle to find relief. Rates of depression and anxiety in adult males with a lifetime history of prostate cancer, one of the main comorbidities of UI, are significantly increased (11,12). There is a need for additional alternatives for the long-term management of UI.

Contino® is a non-surgical, self-administered, class II medical device that inserts into the distal urethra to temporarily block urine flow. A prospective, multi-site, single-arm trial investigated its safety and efficacy in managing urinary incontinence in 15 participants. The study demonstrated that the use of Contino® resulted in a reduction of mean scores of the International Consultation of Incontinence Questionnaire – Short Form (ICIQ-SF; from 16.5 to 12.2), a validated scale to measure the subjective severity of urinary loss (22). The use of Contino® also resulted in a reduction in mean pad weight (471.4g to 149.1g), with minimal adverse events that virtually all resolved with no medical intervention (21). In addition to its primary outcome, Contino® improved quality of life scores and was well-tolerated. Contino® may serve as an alternative treatment option for men with SUI.



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