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Augmenting Urinary Reflex Activity Study 4 (Including eXtended Indications)

NCT06885931 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 86

Last updated 2026-05-15

No results posted yet for this study

Summary

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

Conditions

  • Mixed Urinary Incontinence
  • Stress Urinary Incontinence (SUI)
  • Chronic Pelvic Pain
  • Urge Urinary Incontinence

Interventions

DEVICE

Pudendal neuromodulation

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

Sponsors & Collaborators

  • Amber Therapeutics Ltd

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
22 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-06-24
Primary Completion
2027-06-30
Completion
2030-01-31

Countries

  • Belgium
  • Netherlands
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06885931 on ClinicalTrials.gov