Decentralized trial links intervention to reduction in urinary incontinence

A fully virtual clinical trial has generated data on the use of a digital therapeutic device for the training of pelvic floor muscles by women with urinary incontinence.

Renovia, the developer of the device, sponsored the prospective randomized controlled superiority trial and worked with ObvioHealth to run the study during the COVID-19 pandemic without requiring subjects to visit study centers in person. The trial’s four investigators recently published details of the study in the journal Obstetrics & Gynecology​.

“The virtual nature of the study was novel and permitted nationwide recruitment of community-dwelling participants despite the COVID-19 pandemic, including those outside the reach of major academic medical centers, where large trials often take place. The virtual study design also allowed for uninterrupted data collection during the COVID-19 pandemic​,” the investigators said.

Adverts on Facebook, Instagram, and Twitter alerted women about the study, leading more than 5,000 people to undergo screening. The investigators randomized 363 of those women to use Renovia’s digital therapeutic or to enter the control cohort.

The investigators noted the large number of people screened for every eligible participant, pointing to Pfizer’s pioneering REMOTE clinical trial, which struggled to recruit subjects, as evidence that the high ratio “may be typical of virtually conducted studies.​” While only a fraction of potential participants met the eligibility criteria, Renovia still enrolled enough subjects to run the study.

Participants in the intervention arm received the Renovia device and written instructions in the post. As the trial tested a multi-use device, the direct-to-patient logistics were simpler than for studies of drugs that can necessitate multiple shipments across the course of a trial and require patients to store stocks at home. Participants in the control group received written and video instructions in the post.

After receiving the materials, participants confirmed delivery in the data collection app. The participants were asked to schedule three phone calls with clinical study staff to ensure they were comfortable with the educational materials, and to complete eight weeks of training using either the device or the control materials.

Renovia captured data at baseline, week four, and week eight, with the UDI-6 questionnaire of urinary incontinence symptoms used to collect the primary endpoint results. While UDI-6 scores improved in both cohorts, the decline was steepest in the intervention arm, causing the study to find that Renovia’s device was superior to the control.

The investigators identified some limitations of the fully virtual trial, listing the inability to conduct a physical examination before enrollment as a weakness. The study sought to work around the limitations, for example by asking a question about whether patients saw or felt a bulge to address a pelvic organ prolapse exclusion criteria.