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Search / Trial NCT06659536

Cefar URO - Symptomatic Treatment of Overactive Bladder

Launched by DJO UK LTD · Oct 24, 2024

Trial Information

Current as of July 01, 2025

Not yet recruiting

Keywords

Urinary Urgency Overactive Bladder (Oab) Transcutaneous Tibial Nerve Stimulation (Ttns) Cefar Uro

ClinConnect Summary

The Cefar URO trial is studying a new device designed to help adults with overactive bladder (OAB), which means they often feel a strong, urgent need to urinate and may experience leaking. This clinical trial will specifically look at one of the device's settings, called program P4, to see how well it works for treating urge incontinence, a common symptom of OAB. The goal is to gather important information about the safety and effectiveness of this treatment to fill in some gaps in existing knowledge.

To be eligible for the trial, participants must be adults aged 18 or older who have been diagnosed with overactive bladder and need help managing their symptoms. They should be able to use the Cefar URO device at home and have stable medication for incontinence if they are taking any. However, individuals with certain health issues, such as urinary tract infections or serious kidney problems, cannot participate. If you join the study, you can expect to use the device with specific settings for 12 weeks while the researchers monitor its effectiveness and safety. This trial is not yet recruiting participants, so there will be more information available once it starts.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • Adult patients with overactive bladder (including refractory overactive bladder of idiopathic or neurogenic origin) who require symptomatic treatment of urge incontinence and associated symptoms.
  • Subjects, both male and female, ≥ 18 years of age at the time of consent
  • Subjects have provided their written consent to participate in the study by signing the Ethics-approved consent form.
  • Patients are considered able and willing to self-administer transcutaneous tibial nerve stimulator (TTNS) treatment at home, based on Investigator's judgement.
  • Patients are suitable to receive treatment using the Cefar URO device P4 program pre-set parameters (frequency 20Hz and pulse width 200μs) for 12 weeks, based on Investigator's judgement.
  • If undergoing pharmacological therapy for incontinence, the therapy must be stabilized for at least 4 weeks before baseline visit
  • Exclusion Criteria:
  • Pregnancy confirmed by urine test at screening
  • Urinary tract infection confirmed by urine analysis
  • Serious secondary illness (such as renal failure, nephrolithiasis, bladder and kidney tumors)
  • Detrusor-sphincter dyssynergia
  • Patients who have or have had implantable neurostimulating cardiac demand pacemakers, ICD; or other implantable electronic devices
  • Subjects who are not able to read and understand the Instructions for Use, warnings, cautions and dangers
  • Subjects who are not able to read and understand indications and contraindications of the device
  • Subjects who are not able to sense auditory and visual signals
  • Patients with anti-incontinence surgery planned during the course of the study
  • Participation in another clinical study within 30 days prior to screening

About Djo Uk Ltd

DJO UK Ltd. is a leading provider of innovative orthopedic and rehabilitative products, dedicated to enhancing the quality of life for patients through advanced medical solutions. As a subsidiary of DJO Global, the company specializes in the development and commercialization of a broad range of devices, including braces, supports, and physical therapy products. With a strong commitment to research and development, DJO UK Ltd. actively sponsors clinical trials to evaluate the efficacy and safety of its products, ensuring they meet the highest standards of clinical excellence and contribute to improved patient outcomes in musculoskeletal health.

Locations

Paris, , France

Patients applied

0 patients applied

Trial Officials

Gérard Amarenco, Pr.

Principal Investigator

Service de Neuro-Urologie, Hôpital Tenon

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported