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Cefar URO - Symptomatic Treatment of Overactive Bladder

NCT06659536 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 53

Last updated 2025-02-06

No results posted yet for this study

Summary

A Post-Market Prospective Clinical Investigation to collect PMCF data on the safety and performance of the Cefar URO device when using the preset program P4 (parameter setting: frequency 20Hz, pulse width 200μs) for the symptomatic treatment of urge incontinence in adults with overactive bladder in accordance with the approved labelling.

The Cefar URO device features four pre-set programs (P1, P2, P3 and P4) and three custom programs. Although supporting data on the preset programs P1, P2, P3 are available for the clinically equivalent UROstim2 device, program P4 is unique to Cefar URO. Program P4 utilizes the parameters 20Hz and 200μs which are commonly reported in the literature for the stated indications but for which no data is available for the clinically equivalent UROstim2 device. The present study is therefore aimed to cover this data gap.

Conditions

  • Overactive Bladder (OAB)
  • Refractory Overactive Bladder
  • Urinary Urgency and Frequency

Interventions

DEVICE

Transcutaneous Tibial Nerve Stimulation (TTNS) with the Cefar Uro Device

Transcutaneous Tibial Nerve Stimulation (TTNS) with the Cefar URO device using the preset program P4 (parameter setting: frequency 20Hz, pulse width 200μs) for the symptomatic treatment of urge incontinence in adults with overactive bladder in accordance with the approved labelling.

Sponsors & Collaborators

  • DJO UK Ltd

    lead INDUSTRY

Principal Investigators

  • Gérard Amarenco, Pr. · Service de Neuro-Urologie, Hôpital Tenon

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-03-31
Primary Completion
2026-03-31
Completion
2026-03-31

Countries

  • France

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 NCT06659536 on ClinicalTrials.gov