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CLINICAL TRIALS Behavioral Modification Trials in Urology

By: Suraj Pursnani, MD, Penn State Health Milton S. Hershey Medical Center, Hershey, Pennsylvania; Alyssa Cutshaw, BS, Penn State University, University Park, Pennsylvania; David E. Conroy, PhD, Penn State University, University Park, Pennsylvania; Necole M. Streeper, MD, Penn State Health Milton S. Hershey Medical Center, Hershey, Pennsylvania | Posted on: 25 Oct 2023

Behavioral modification has been found to optimize genitourinary (GU) health in various conditions, including preventing kidney stones, enhancing sexual function, preventing GU cancers, and addressing overactive bladder and benign prostatic hyperplasia related urinary symptoms. Long-term adherence is the ultimate goal of health behavior change interventions. A behavioral intervention can lead to a change in motivation, which can result in behavior change and ultimately an improvement in health outcomes. Targets for intervention can include smoking cessation, diet modification, weight loss, increasing physical activity, and voiding habits. Recently, there has been interest in leveraging technology that incorporates behavior change techniques to support behavioral modification and overcome challenges of lifestyle changes, specifically for increasing fluid intake for kidney stone prevention. There have been few clinical trials using behavioral modification, including behavior change techniques within urology to improve both health and surgical outcomes.

For kidney stone disease, there have been ongoing clinical trials using technology with behavioral change techniques to increase fluid intake for prevention. Stone recurrence rates can be high; however, behavioral modifications with increased fluid intake and dietary modification can lower recurrence risks significantly. Unfortunately, it can be difficult for patients to adhere to these recommendations amidst the varied demands of daily life. The sipIT behavioral intervention was developed using patient-input, as a just-in-time reminder system to improve fluid intake for kidney stone prevention.1 It tracks fluid intake automatically through a connected water bottle and drinking gesture detection with a smartwatch, and sends just-in-time reminders via text messaging when fluid intake goals are not met.1 We currently are enrolling patients in a randomized control clinical trial funded by the National Institute of Diabetes and Digestive and Kidney Diseases, with initial results expected in early 2025. We previously conducted 2 studies of the sipIT intervention with patients. In the first study, we provided proof-of-concept for this just-in-time behavioral intervention based on findings that patients reported reductions in major barriers to fluid intake and increases in the experienced automaticity of fluid intake (an indicator of habit strength). In the second study, we evaluated the effects of a mini-sipIT behavioral intervention that incorporated only the connected water bottle and its companion mobile app on 24-hour urine volume after 1 month of using mini-sipIT.2 We found that 90% of participants (n=26) adhered to the behavioral intervention daily through tracking of connected water bottle usage and there was a significant increase in 24-hour urine volume at the end of the 1-month trial.2 Additionally, 73% of participants had increased 24-hour urine volumes, and 42% of participants had volumes greater than 2 liters after 1 month follow-up.2 In addition to our work described above, the Prevention of Urinary Stones with Hydration (PUSH) Study is an ongoing clinical trial that incorporates a behavioral intervention program with a goal to increase and maintain high fluid intake for kidney stone prevention.3 Those in the intervention arm receive a prescription for fluid intake, financial incentives, automated adherence interventions, and structured problem-solving as behavioral interventions.3 Forthcoming results from these trials will help to understand which approaches to behavior change create long-term habit formation and how strategies need to be individualized as there is likely no one-size-fits-all approach.

Within urology, there are trials that focus on nontechnology-based behavioral modifications as well. Behavioral interventions are the first line, nonoperative treatment for overactive bladder and urge urinary incontinence (UI). Common targets of behavioral interventions for this include regulating fluid intake, eliminating caffeine and other bladder irritants from the diet, weight control, smoking cessation, and timed voiding. Bladder training and pelvic floor muscle exercises are also behavioral training techniques included in the behavioral toolkit for UI.4 A trial by Diokno et al evaluated the effectiveness of group session teaching of behavioral modifications in managing female UI.5 Those in the intervention arm underwent a single group session lecture conducted by 2 trained urology nurses on behavioral modifications. The group session was followed by an assessment 2-4 weeks later and 6-8 weeks later. They found that, within the intervention arm, there was a significant reduction in UI severity, increase in pelvic floor muscle strength, and reduction in voiding frequency with group session teaching.5

Smoking cessation reduces risk of most GU cancers and also can improve surgical outcomes, particularly in urinary tract reconstruction and GU prostheses. A study by Bjurlin et al enrolled adult smokers from a single institution urology clinic between 2009 and 2011 in a prospective, brief intervention trial.6 Patients in the intervention arm received a 5-minute brief smoking cessation intervention with the primary outcome being abstinence at 1 year and the secondary outcome was number of attempts to quit.6 They found a 12.1% quit rate in the brief smoking cessation intervention vs 2.6% in the usual care group.6 Patients who received the intervention were also significantly more likely to attempt to quit.6 Smoking cessation remains a vexing challenge, but this study highlights the significant impact urologists can make in smoking cessation with just a brief intervention.

The combination of physical activity, dietary modifications, and smoking cessation can improve cardiovascular health, but importantly for the urologic population, it can enhance sexual and erectile function. By 2025, the prevalence of erectile dysfunction (ED) worldwide will be over 300 million cases.7 As a result, targeting modifiable behavioral risk factors for ED is of increasing interest. Esposito et al performed a randomized controlled trial of 110 obese men with ED with the behavioral intervention arm receiving a detailed individualized program to reduce weight by 10% or more through diet modification and increase in physical activity.8 The intervention included behavior change techniques including goal-setting and self-monitoring with food diaries, in addition to behavioral and psychological therapy.8 Those in the intervention group had a significant decrease in body mass index, increase in physical activity, and improved sexual function.8

There are multiple GU conditions that can benefit from behavioral interventions. There is a paucity of clinical trials in several areas where patient outcomes could improve with leveraging behavioral science. Urologists should work with scientists specializing in behavior change to help improve the impact of behavioral modification interventions on various GU conditions.

  1. Conroy DE, West AB, Brunke-Reese D, Thomaz E, Streeper NM. Just-in-time adaptive intervention to promote fluid consumption in patients with kidney stones. Health Psychol. 2020;39(12):1062-1069.
  2. Streeper NM, Fairbourn JD, Marks J, Thomaz E, Ram N, Conroy DE. Feasibility of mini sipIT behavioral intervention to increase urine volume in patients with kidney stones. Urology. 2023;S0090-4295(23)00563-0.
  3. Scales CD Jr, Desai AC, Harper JD, et al. Urinary stone disease research network. Prevention of urinary stones with hydration (PUSH): design and rationale of a clinical trial. Am J Kidney Dis. 2021;77(6):898-906.e1.
  4. Wyman JF, Burgio KL, Newman DK. Practical aspects of lifestyle modifications and behavioural interventions in the treatment of overactive bladder and urgency urinary incontinence. Int J Clin Pract. 2009;63(8):1177-1191.
  5. Diokno AC, Ocampo MS, Ibrahim IA, Karl CR, Lajiness MJ, Hall SA. Group session teaching of behavioral modification program (BMP) for urinary incontinence: a randomized controlled trial among incontinent women. Int Urol Nephrol. 2010;42(2):375-381.
  6. Bjurlin MA, Cohn MR, Kim DY, et al. Brief smoking cessation intervention: a prospective trial in the urology setting. J Urol. 2013;189(5):1843-1849.
  7. Maiorino MI, Bellastella G, Esposito K. Lifestyle modifications and erectile dysfunction: what can be expected?. Asian J Androl. 2015;17(1):5-10.
  8. Esposito K, Giugliano F, Di Palo C, et al. Effect of lifestyle changes on erectile dysfunction in obese men a randomized controlled trial. JAMA. 2004;291(24):2978-2984.

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