Overactive BladderNCT06847789
Evaluation of the Tensi+ Device for the Treatment of Overactive Bladder
An observational study of Overactive Bladder, run by Stimuli Technology at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Overactive Bladder
- What is being tested?
- Tensi+
- Type of treatment
- Medical device
- How many people
- 79 participants
- Where
- 1 siteFrance
- Study dates
- 25 May 2022to 15 May 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Age ≥ 18 years Overactive bladder symptoms
Who may be able to join
- Age ≥ 18 years
- Patients suffering from Overactive bladder symptoms
Who cannot join
- 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
Show all 17Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Tensi+ Device for the Treatment of Overactive Bladder: Prospective Study
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.
Read more
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
- Being tested
- Tensi+
- Keywords
- Urology, TENS, Overactive bladder
- Medical subject headings
- Urinary Bladder, Overactive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective improvement
At least 30% decrease of urgency episodes compared to baseline on 3-day bladder diary
Measured: At 3 months
Subjective improvement
Patient Global Impression of Improvement score of 1 or 2
Measured: At 3 months
Secondary outcomes (5)
Evaluation of urinary symptoms
Bladder diary parameters evaluation (urinary frequency, incontinence episodes, maximum bladder capacity, nocturia episodes) and the Urinary Symptom Profile (USP) questionnaire
Measured: At 3 months and 6 months
Evaluation of adverse events
Questions to be asked to patients at 3 months and 6 months if there were any adverse events during treatment
Measured: At 3 months and 6 months
Patient-reported Outcomes Measures (PROMs)
Comfort of use, recommendation to another patient (binary), consumer grading regarding device usability details
Measured: At 3 months and 6 months
Quality of life measures
By filling up OABq questionnaire and VAS scale
Measured: At 3 months and 6 months
Assessment of treatment persistence
Measured: At 3 months and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2025
- Study start25 May 2022
- Primary completion15 May 2023
- Study completion15 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Overactive BladderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 79 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stimuli Technology
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06847789
- Sponsor's protocol ID
- 2022-171221-01 / 1
- Status last verified
- Feb 2025
- First submitted
- 8 Jul 2022
- Last updated
- 26 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Tensi+ Device for the Treatment of Overactive Bladder: Prospective Study
- ClinicalTrials.gov ID
- NCT06847789
- Acronym / sponsor ID
- 2022-171221-01 / 1
- Conditions
- Overactive Bladder
- Keywords
- Urology, TENS, Overactive bladder
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 79 participants (actual)
- Lead sponsor
- Stimuli TechnologyIndustry (pharma, biotech, devices)
- Study start
- 25 May 2022 (actual)
- Primary completion
- 15 May 2023 (actual)
- Study completion
- 15 May 2023 (actual)
- First posted
- 26 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Age ≥ 18 years Overactive bladder symptoms
Key inclusion criteria (2 listed)
- Age ≥ 18 years
- Patients suffering from Overactive bladder symptoms
Key exclusion criteria (17 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tensi+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. | Device | – |
Primary outcome
Objective improvement
Time frame: At 3 months
At least 30% decrease of urgency episodes compared to baseline on 3-day bladder diary
Subjective improvement
Time frame: At 3 months
Patient Global Impression of Improvement score of 1 or 2
5 secondary outcomes
Evaluation of urinary symptoms
Time frame: At 3 months and 6 months
Evaluation of adverse events
Time frame: At 3 months and 6 months
Patient-reported Outcomes Measures (PROMs)
Time frame: At 3 months and 6 months
Quality of life measures
Time frame: At 3 months and 6 months
Assessment of treatment persistence
Time frame: At 3 months and 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Overactive Bladder, run by Stimuli Technology at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective improvement (time frame: At 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Feb 2025.