Evaluation of the Tensi+ Device for the Treatment of Overactive Bladder

Completed

• Conditions: Overactive Bladder

• Registration Number: NCT06847789
• Lead Sponsor: Stimuli Technology

Brief Summary

Tensi+ (Stimuli Technology, Boulogne Billancourt, France) is a newly released, medical transcutaneous-posterior tibial nerve stimulation (TC-pTNS) device marketed for overactive bladder (OAB) management. While effectiveness of TC-pTNS has been demonstrated in the literature, the success rate is heterogeneous, depending on the clinical picture. In an effort to ascertain clearly the efficacy of Tensi+ device, as well as its safety of use and assess comfort of use, the present study will evaluate the results of Tensi+ treatment in real life conditions in a prospective study. The main objective is to assess the efficacy (actual clinical benefit) of TC-pTNS with Tensi+ device for management of overactive bladder in an adult population at 3 months.

Included patients are prescribed a treatment with Tensi+ for 3 months. An evaluation visit is scheduled at 3 months. In treatment is continued, a follow-up visit is scheduled at 6 months.

Primary outcome measure

Success at 3 months defined as a composite parameter:

(i) Objective improvement, with at least 30% decrease of urgency episodes compared to baseline on 3-day bladder diary AND (ii) Subjective improvement, with patient Global Impression of Improvement score of 1 or 2 Time point(s) at which primary outcome measure is assessed : 3 months Secondary outcome measures (i) Evaluation of urinary symptoms based on bladder diary parameters (urinary frequency, incontinence episodes, maximum bladder capacity, nocturia episodes) and the Urinary Symptom Profile (USP) questionnaire (ii) Evaluation of adverse events (iii) Patient-reported Outcomes Measures (PROMs): Comfort of use (VAS in deciles), recommendation to another patient (binary), consumer grading regarding device usability details (iv) Quality of life measures (OABq questionnaire, VAS scale) (vii) Assessment of treatment persistence Time point(s) at which Secondary outcome measure is assessed\* : at 3 months and 6 months

Inclusion criteria : Age ≥ 18 years Overactive bladder symptoms

Number of subjects : 100

Detailed Description

Not available

Study Timeline

• Study Start: 2022-05-25
• Study First Submitted: 2022-07-08
• Primary Completion: 2023-05-15
• Study Completion: 2023-05-15
• Status Verified: 2025-02
• Study First Submitted QC: 2025-02-21
• Last Update Submitted: 2025-02-21
• Study First Posted: 2025-02-26
• Last Update Posted: 2025-02-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 79

Inclusion Criteria

• Age ≥ 18 years
• Patients suffering from Overactive bladder symptoms

Exclusion Criteria

• Pregnancy
• Patients with active implantable device or ankle orthopedic implant,
• Ankle articular diseases.
• Prior treatment with transcutaneous PTNS or percutaneous PTNS (any time),
• Sacral neuromodulation (anytime) or,
• Intradetrusor botulinum toxin injection within the past 6 months
• Antimuscarinic use within 1 month prior to the study
• 24hour diuresis > 2800cc on bladder diary
• Known bladder disease
• Active urinary tract infection
• PVR> 150 ml
• Pelvic organ prolapse stage >2
• Predominant stress urinary incontinence
• Cognitive impairment
• Inability to use the device without a third party
• Inability to complete a bladder diary
• No health insurance coverage

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Objective improvement	At 3 months	At least 30% decrease of urgency episodes compared to baseline on 3-day bladder diary
Subjective improvement	At 3 months	Patient Global Impression of Improvement score of 1 or 2

Secondary Outcome Measures

Name	Time	Method
Evaluation of adverse events	At 3 months and 6 months	Questions to be asked to patients at 3 months and 6 months if there were any adverse events during treatment
Evaluation of urinary symptoms	At 3 months and 6 months	Bladder diary parameters evaluation (urinary frequency, incontinence episodes, maximum bladder capacity, nocturia episodes) and the Urinary Symptom Profile (USP) questionnaire
Patient-reported Outcomes Measures (PROMs)	At 3 months and 6 months	Comfort of use, recommendation to another patient (binary), consumer grading regarding device usability details
Quality of life measures	At 3 months and 6 months	By filling up OABq questionnaire and VAS scale
Assessment of treatment persistence	At 3 months and 6 months

Trial Locations

Locations (1)

CHU Rouen; 🇫🇷 Rouen, France