Clinical trial disruption in urinary incontinence: A cross-sectional analysis from 2008-2023

Objective: Our primary objective was to examine the rates of urinary incontinence clinical trial disruption from January 1, 2008 through March 10, 2023. Secondarily, we determined prevalence rates for specific urinary incontinence type, reason for trial discontinuation, and intervention type.

Methods: We conducted a search of ClinicalTrials.gov on March 10, 2023 and identified clinical trials that had been suspended, terminated, or withdrawn during the specified timeframe — January 1, 2008 to March 10, 2023. Date of termination was determined by the date of the last post. We also extracted data for the type of urinary incontinence, type of intervention, location of study (US vs Non-US), funding source, and reasoning for trial discontinuation and calculated prevalence rates for each variable.

Results: The search returned 223 trials, which, after excluding studies that were not related to our objective, 107 trials were analyzed that had been discontinued. Between 2013 and 2022, an average of 9.7 trials per year had been discontinued with the highest annual number (n=13) being discontinued in 2018 and 2020 (Figure 1). Interestingly, trial discontinuation rates did not increase in 2020, during the COVID-19 shutdowns. Among the trials, overactive bladder/urge incontinence (n=67; 62.62%; Table 1) and stress incontinence (n=29; 27.10%) had the highest rates of discontinuation. The most common reasons for discontinuation were insufficient recruitment (n=43; 40.19%) and no reason provided (n=12; 11.21 %).

Conclusion: Our results showed that clinical trial disruptions over time have remained relatively steady. Additionally, COVID-19 shutdowns in 2020 seemingly had little impact on trial discontinuation rates. Our findings also highlight insufficient recruitment as the top reason reported for trial discontinuation. This could be due to the fact that many women suffering from urinary incontinence do not seek medical care. Additionally, the potential psycho-social burden and decrease in quality of life women may face when dealing with this condition may play a role. Future research could analyze whether the insufficient recruitment increased during COVID-19 and determine if COVID-19 is a potential cause. Further, research should focus on potential recruitment strategies to increase trial participation. Increased trial participation could lead to improvement in incontinence treatment modalities, thus increasing quality of life.