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RECRUITING
NCT06885931
NA

Augmenting Urinary Reflex Activity Study 4 (Including eXtended Indications)

Sponsor: Amber Therapeutics Ltd

View on ClinicalTrials.gov

Summary

Exploratory safety and feasibility study of personalized adaptive pudendal neuromodulation for mixed urinary incontinence and extended indications using an implanted (Picostim™ II) system.

Official title: Exploratory Safety and Feasibility Study of Personalized Adaptive Pudendal Neuromodulation for Mixed Urinary Incontinence and Extended Indications Using an Implanted (Picostim IITM) System

Key Details

Gender

FEMALE

Age Range

22 Years - Any

Study Type

INTERVENTIONAL

Enrollment

56

Start Date

2025-06-24

Completion Date

2029-08

Last Updated

2026-03-19

Healthy Volunteers

No

Interventions

DEVICE

Pudendal neuromodulation

In this feasibility study, all subjects will receive the Amber UI system.

Locations (5)

UZ Leuven

Leuven, Herestraat 49, Belgium

Universitair Ziekenhuis Antwerpen

Edegem, Belgium

Ghent University Hospital

Ghent, Belgium

Maastricht UMC

Maastricht, Netherlands

University College London Hospital

London, United Kingdom