Clinical trial NCT06847789: Evaluation of the Tensi+ Device for the Treatment of Overactive Bladder
Official title: Evaluation of the Tensi+ Device for the Treatment of Overactive Bladder: Prospective Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Overactive Bladder
Keywords: Urology
TENS
Overactive bladder
Lead sponsor: Stimuli Technology
Sponsor class: INDUSTRY
First posted: 2025-02-26
Enrollment: 79
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Age ≥ 18 years Overactive bladder symptoms

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


Eligibility criteria: 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

Primary outcomes:
measure: Objective improvement
timeFrame: At 3 months
measure: Subjective improvement
timeFrame: At 3 months
Secondary outcomes:
measure: Evaluation of urinary symptoms
timeFrame: At 3 months and 6 months
measure: Evaluation of adverse events
timeFrame: At 3 months and 6 months
measure: Patient-reported Outcomes Measures (PROMs)
timeFrame: At 3 months and 6 months
measure: Quality of life measures
timeFrame: At 3 months and 6 months
measure: Assessment of treatment persistence
timeFrame: At 3 months and 6 months
Other outcomes:
Locations:
city: Rouen
country: France
facility: CHU Rouen
Study officials:
References: