INTIBIA Pivotal Study

NAActive, not recruitingINTERVENTIONAL
Enrollment

208

Participants

Timeline

Start Date

March 7, 2022

Primary Completion Date

June 27, 2025

Study Completion Date

June 27, 2026

Conditions
Urinary Incontinence, UrgeUrinary Bladder, OveractiveUrinary Bladder DiseasesUrologic DiseasesLower Urinary Tract SymptomsUrological Manifestations
Interventions
DEVICE

INTIBIA Therapeutic

INTIBIA implantable tibial nerve stimulator with therapeutic stimulation

DEVICE

INTIBIA Non-Therapeutic

INTIBIA implantable tibial nerve stimulator with non-therapeutic stimulation for 3 months, then therapeutic stimulation

Trial Locations (22)

18103

The Institute for Female Pelvic Medicine and Reconstructive Surgery- Axia Womens Health, Allentown

18940

The Female Pelvic Health Center, Newtown

19004

MidLantic Urology, Bala-Cynwyd

19107

Thomas Jefferson University, Philadelphia

20010

MedStar Washington Hospital Center, Washington D.C.

27103

Wake Forest University, Winston-Salem

31768

Southeastern Urogynecology & Pelvic Surgery, Moultrie

32114

Advanced Urology Associates, Daytona Beach

44109

MetroHealth System, Cleveland

45212

The Urology Group, Cincinnati

48109

University of Michigan, Ann Arbor

48124

Advanced Urogynecology of Michigan, Dearborn

63141

Specialty Clinical Research of St. Louis, St Louis

67226

Cypress Medical Research Center, LLC, Wichita

77027

Houston Metro Urology, Houston

83402

Rosemark WomenCare Specialists, Idaho Falls

90017

Urology Group of Southern California, Los Angeles

90211

Cedars-Sinai Medical Group, Beverly Hills

01199

Baystate Medical Center, Springfield

07834

Atlantic Health System - AMG Urology (Garden State Urology), Denville

1081 GG

Bergman Clinics, Women's Health, Department of Gynecology, Amsterdam

8025 AB

Isala Zwolle, Zwolle

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Coloplast A/S

INDUSTRY