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

NCT06847789 | Completed

• 1 other identifier: 2022-171221-01 / 1
• Study Type: observational
• Target: 79
• Locations: 1 country
• Sites: 1

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

Conditions

Overactive Bladder

Keywords

Urology; TENS; Overactive bladder

Outcome Measures

Primary Outcomes (2)

• Objective improvement

  At least 30% decrease of urgency episodes compared to baseline on 3-day bladder diary

  At 3 months

• Subjective improvement

  Patient Global Impression of Improvement score of 1 or 2

  At 3 months

Secondary Outcomes (5)

• Evaluation of urinary symptoms

  At 3 months and 6 months

• Evaluation of adverse events

  At 3 months and 6 months

• Patient-reported Outcomes Measures (PROMs)

  At 3 months and 6 months

• Quality of life measures

  At 3 months and 6 months

• Assessment of treatment persistence

  At 3 months and 6 months

Interventions

Tensi+ DEVICE

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.

Eligibility Criteria

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

Study Population

Age ≥ 18 years Overactive bladder symptoms

You may qualify if:

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

You may not qualify if:

• 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
• hour 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

Sponsors & Collaborators

• Stimuli Technology: lead

Study Sites (1)

CHU Rouen

Rouen, 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 Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 8, 2022
• First Posted: February 26, 2025
• Study Start: May 25, 2022
• Primary Completion: May 15, 2023
• Study Completion: May 15, 2023
• Last Updated: February 26, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)