FDA approves IDE for study evaluating underactive bladder device

The FDA has approved an investigational device exemption for an early feasibility study (EFS) that will evaluate safety and efficacy for an investigational implantable device for the treatment of underactive bladder, iota Biosciences announced in a news release.¹

According to iota Biosciences, a wholly owned subsidiary of Astellas Pharma Inc, the device is “designed to deliver electrical stimulation directly to the bladder wall, inducing contractions that facilitate bladder emptying in individuals impacted by underactive bladder.”

"Current treatment options for underactive bladder are limited, often forcing patients to rely on clean intermittent catheterization, which can be burdensome and carry risk of complications. Our team has diligently worked on a potential alternative treatment option, achieving concept to IDE approval in less than 4 years, a remarkable feat that highlights our commitment to patients and innovation. We are excited to advance clinical development and bring this potential new solution closer to those in need,” said iota Biosciences CEO Michel Maharbiz, PhD, in a news release.

Gopal H. Badlani, MD

In correspondence with Urology Times, Gopal H. Badlani, MD, called underactive bladder “a significant clinical issue that affects men and women.”

“It affects the quality of life with bothersome lower urinary tract symptoms of frequency, incomplete emptying of the bladder, and slow flow. Currently, there are no pharmacological or surgical therapies that can improve the situation. The cause can be primary smooth muscle weakness, due to chronic stretching due to retained urine, or neuropathy (nerve injury),” added Badlani, Co–Editor-in-Chief for Urology Times and professor and vice chair of urology at Wake Forest University in Winston-Salem, North Carolina.

According to the release, the FDA’s approval of the EFS of the device is a staged approval. For the first stage, 3 patients (at least 1 male and 1 female) will be enrolled. Upon achievement of successful safety outcomes from this stage, the FDA approved expansion of the study to include a total of 10 patients.

"The initiation of the early feasibility study reflects our shared commitment to expand treatment options beyond traditional pharmaceuticals through innovative science and health technologies,” commented Adam Pearson, chief strategy officer for Astellas Pharma. “We look forward to the progress of this research, and its potential to make a difference for patients impacted by underactive bladder."

Added Badlani in his comments, “Current management [of underactive bladder] is mechanical drainage with intermittent self or continued catheter…Current techniques of neuromodulation are not approved or indicated in patients with underactive bladder. The technique by iota Biosciences/Astellas is not detailed but is certainly exciting, and the results would be eagerly awaited,” Badlani added.

REFERENCE

1. FDA grants iota Biosciences IDE approval for first-in-human early feasibility study with implantable bladder device. News release. Astellas Pharma Inc. October 10, 2024. Accessed October 15, 2024. https://newsroom.astellas.us/2024-10-10-FDA-Grants-iota-Biosciences-IDE-Approval-for-First-In-Human-Early-Feasibility-Study-with-Implantable-Bladder-Device