NCT07209397 - Detrusor Nerve Radiofrequency Ablation for Overactive Bladder in Women: A Randomized Controlled Trial | Biotech Hunter

Enrollment

202

Participants

Timeline

Start Date

October 13, 2025

Primary Completion Date

May 31, 2027

Study Completion Date

November 30, 2027

Conditions

Overactive BladderOveractive Bladder (OAB)Urge Urinary IncontinenceMixed Urinary Incontinence (Urge-Predominant)Mixed Urinary IncontinenceIdiopathic Overactive Bladder With Urinary IncontinenceIdiopathic Overactive Bladder

Interventions

DEVICE

Detrusor nerve radiofrequency ablation

A single, vaginal radiofrequency (RF) treatment. The procedure is performed with a bipolar RF applicator and requires no anesthesia. Delivered in a single session in an outpatient setting.

DEVICE

Simulated (sham) detrusor nerve radiofrequency ablation

A simulated (sham) radiofrequency (RF) treatment, but with no energy delivered. The procedure mimics the appearance, duration, and positioning of the active device, without therapeutic effect.

Trial Locations (11)

20010

MedStar Health Research Institute, Washington D.C.

27455

Atrium Health Wake Forest Female Pelvic Health Division, Greensboro

44109

MetroHealth Cleveland, Cleveland

60062

University of Chicago Medicine Urogynecology, Chicago

67226

Cypress Medical Research Center, Wichita

68114

Urology Center, P.C., Omaha

78745

Urology Austin, Austin

83702

Advanced Specialty Research, Boise

89154

UNLV Kirk Kerkorian School of Medicine Department of Gynecologic Surgery & Obstetrics, Las Vegas

94304

Stanford Medicine Department of Obstetrics & Gynecology, Palo Alto

02472

Bay State Clinical Trials, Watertown

All Listed Sponsors

collaborator

Foundation for Female Health Awareness

OTHER

lead

InMode MD Ltd.

INDUSTRY