Cefar URO - Symptomatic Treatment of Overactive Bladder
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorDJO UK Ltd
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
Transcutaneous Tibial Nerve Stimulation (TTNS) with the Cefar Uro Device
DeviceTranscutaneous 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.
Treatment groups
53 Participants
are divided into 1 treatment groupGroup A: Transcutaneous Tibial Nerve Stimulator (TTNS) with the Cefar Uro DeviceExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
From enrollment to the end of Treatment at 16 weeks.2
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.
Time frame
From enrollment to the end of Treatment at 12 weeks.Secondary outcomes
1
Number of Urinary Urgency and Urinary Frequency Episodes
\- change in the number of episodes of Urinary Urgency and Urinary Frequency measured at 12 weeks compared to baseline, measured by means of 3-day bladder patient diary. This will quantify the average number of urgency and frequency episodes per day over three consecutive days, allowing for a direct comparison of baseline and 12-week data.
Time frame
From enrollment to the end of Treatment at 12 weeks.2
Change in Quality of Life
\- change in Health-Related Quality of Life as shown by a reduction in the Overactive Bladder-questionnaire-Short Form (OAB-q-SF), Health-Related Quality of Life (HRQoL) (13 items) at 12 weeks relative to baseline, based on patient self reported outcomes. To assess the quality of life, the lowest score is 13 and the highest is 78. Higher scores will be indicative of better HRQL.
Time frame
From enrollment to the end of Treatment at 12 weeks.Other outcomes
1
Number of Urinary Incontinence and Nocturia episodes
\- change in the number of episodes of Urinary Incontinence and Nocturia, assessed at 12 weeks compared to baseline using a 3-day bladder diary. This endpoint will quantify the average daily episodes for both incontinence and nocturia across three consecutive days, enabling a direct comparison of baseline and 12-week data.
Time frame
From enrollment to the end of Treatment at 12 weeks.2
Frequency of Overactive Bladder Symptoms at a longer term follow up
\- Maintenance of Symptoms Bother between 12 and 16 weeks, assessed using the Symptoms Bother Scale from the Overactive Bladder-questionnaire-Short Form (OAB-q-SF). Maintenance will be defined as no statistically significant worsening in symptom-related distress between 12 and 16 weeks. 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.
Time frame
From enrollment to the end of Treatment at 16 weeks.3
Change in Quality of Life at a longer term follow up
\- maintenance of Health-Related Quality of Life (HRQoL) between 12 and 16 weeks, measured using the HRQoL component of the Overactive Bladder-questionnaire-Short Form (OAB-q-SF). Maintenance will be defined as no statistically significant worsening in HRQoL scores over this period. To assess the quality of life, the lowest score is 13 and the highest is 78. Higher scores will be indicative of better HRQL.
Time frame
From enrollment to the end of Treatment at 16 weeks.4
Frequency of Overactive Bladder Symptoms and Change in Quality of Life at a longer term follow up
\- Maintenance of urinary symptom severity between 12 and 16 weeks, measured using the 3-day bladder diary. Maintenance will be defined as no statistically significant increase in the average daily episodes of Urinary Urgency, Frequency, Incontinence, and Nocturia over three consecutive days..
Time frame
From enrollment to the end of Treatment at 16 weeks.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
DJO UK Ltd
Lead sponsor
Donawa Lifescience Consulting S.r.l.
Collaborator
Source ClinicalTrials.gov