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NCT Number: NCT06847789

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

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

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU Rouen

Rouen, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Objective improvement

    Time frame: At 3 months

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

  2. Subjective improvement

    Time frame: At 3 months

    Patient Global Impression of Improvement score of 1 or 2

Secondary outcomes

  1. Evaluation of urinary symptoms

    Time frame: 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

  2. Evaluation of adverse events

    Time frame: 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

  3. Patient-reported Outcomes Measures (PROMs)

    Time frame: At 3 months and 6 months

    Comfort of use, recommendation to another patient (binary), consumer grading regarding device usability details

  4. Quality of life measures

    Time frame: At 3 months and 6 months

    By filling up OABq questionnaire and VAS scale

  5. Assessment of treatment persistence

    Time frame: At 3 months and 6 months

Sponsors and collaborators

Lead sponsor

Stimuli Technology

Industry

Registry information

Official study title

Evaluation of the Tensi+ Device for the Treatment of Overactive Bladder: Prospective Study

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Feb 26, 2025
Registry last updated
Feb 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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