Cefar URO - Symptomatic Treatment of Overactive Bladder

NCT06659536 | Not Yet Recruiting

• 1 other identifier: ENOVIS-S-INP-0003
• Study Type: interventional
• Target: 53
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Urinary urgency; Overactive Bladder (OAB); Transcutaneous Tibial Nerve Stimulation (TTNS); Cefar Uro

Outcome Measures

Primary Outcomes (2)

• Incidence of Treatment-Emergent Adverse Events

  \- adverse events/malfunctions/complications reported during the study. Subjects and Investigators will be prompted to record such issues on the AE evaluation form.

  From enrollment to the end of Treatment at 16 weeks.

• Frequency of Overactive Bladder Symptoms

  \- change in symptoms, at 12 weeks, quantified as the mean change from baseline on the Overactive Bladder-questionnaire-Short Form (OAB-q-SF), Symptoms bother scale (6 items) based on patient self-reporting. The lowest score for symptoms is 6, and the highest is 36. Higher score values are indicative of grater symptom bother and lower scores indicate minimal symptom bother. As per the literature (Zonic-Imamovic et al.,2021), we may expect an approximate mean reduction of the Symptoms Bother scale of 10.4 points at 12 weeks compared to the baseline measurement.

  From enrollment to the end of Treatment at 12 weeks.

Secondary Outcomes (2)

• Number of Urinary Urgency and Urinary Frequency Episodes

  From enrollment to the end of Treatment at 12 weeks.

• Change in Quality of Life

  From enrollment to the end of Treatment at 12 weeks.

Other Outcomes (5)

• Number of Urinary Incontinence and Nocturia episodes

  From enrollment to the end of Treatment at 12 weeks.

• Frequency of Overactive Bladder Symptoms at a longer term follow up

  From enrollment to the end of Treatment at 16 weeks.

• Change in Quality of Life at a longer term follow up

  From enrollment to the end of Treatment at 16 weeks.

Study Arms (1)

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

EXPERIMENTAL

Patients will undergo Transcutaneous Posterior Tibial Nerve Stimulation with the Cefar URO device. The following parameters setting (preset program P4) will be used for treatment of all enrolled subjects: * frequency of 20Hz * pulse width of 200 μs * duration: 30 minutes per treatment. * treatment frequency: subjects will be recommended to have 7 treatment sessions per week for a total of 12 weeks (84 treatments total), and anyway no less that one treatment per week. The electrodes will be placed in the medial ankle as according to the device IFU.

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

Interventions

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

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• DJO UK Ltd: lead

Study Sites (1)

Neuro-Urology Department, Tenon Hospital

Paris, 75020, France

Location

MeSH Terms

Conditions

Urinary Bladder, Overactive

Condition Hierarchy (Ancestors)

Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Gérard Amarenco, Pr.

  Service de Neuro-Urologie, Hôpital Tenon

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Veronica Sebeo

CONTACT

+49 15146128712; prci@enovis.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 22, 2024
• First Posted: October 26, 2024
• Study Start: March 1, 2025
• Primary Completion: March 1, 2026
• Study Completion: March 1, 2026
• Last Updated: February 6, 2025

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)