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Treatment of REfractory Overactive BLadder With the AXonics Sacral Neuromodulation System (RELAX-OAB)

NCT02620410 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 51

Last updated 2024-08-09

No results posted yet for this study

Summary

The RELAX-OAB (Treatment of REfractory Overactive BLadder with the AXonics Sacral Neuromodulation System) is a post-market clinical follow-up (PMCF) study designed to confirm the performance of the Axonics Sacral Neuromodulation (SNM) System as an aid in the treatment of the symptoms of overactive bladder (OAB) as well as capturing patient satisfaction and quality of life data.

Conditions

Interventions

DEVICE

Axonics Sacral Neuromodulation (SNM) System

The implantable components of the Axonics Sacral Neuromodulation (SNM) System consist of an IPG and tined lead. Additional components include a clinician programmer, surgical tool kit, recharging kit, and patient remote control.

Sponsors & Collaborators

  • Axonics, Inc.

    lead INDUSTRY

Principal Investigators

  • Sohier Elneil, MRCOG, PhD · University College London Hospital & National Hospital for Neurology & Neurosurgery

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-06-30
Primary Completion
2017-06-30
Completion
2022-01-31

Countries

  • Belgium
  • France
  • Netherlands
  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

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 NCT02620410 on ClinicalTrials.gov