Overactive BladderTENVESINCT06484023
Posterior Tibial Transcutaneous Neurostimulation in Idiopathic Overactive Bladder
An observational study of Overactive Bladder, run by Hopital Nord Franche-Comte at 1 site in France.
Trial summary
Overactive bladder is a clinical diagnosis affecting up to 17% of women. The existing medical treatment, anticholinergics, has many side effects and is sometimes ineffective. Neurostimulation of the posterior tibial nerve is a validated 3rd-line therapy, after failure of perineal re-education and medication. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Overactive Bladder
- What is being tested?
- Survey
- How many people
- 45 participants
- Where
- 1 siteFrance
- Study dates
- 29 Mar 2024to 17 Jun 2024
- 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
- Women only
- Adult, Older adult
Study population: Patients treated for overactive bladder and using the TENSI+ for at least 3 months
Who may be able to join
- Patients treated for overactive bladder
- Patients using the TENSI+ for at least 3 months
Who cannot join
- Neurological disease that may explain overactive bladder
- Patient having received anticholinergic drug treatment during neurostimulation.
- Have one or more contraindications to wearing the device: pacemaker, defibrillator, wearing a mechanical implant near the electrode placement area, ankle joint problems, damaged skin, cognitive impairment.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Place and Efficacy of Treatment With Posterior Tibial Transcutaneous Neurostimulation in Women With Idiopathic Overactive Bladder
Overactive bladder is a clinical diagnosis affecting up to 17% of women. The existing medical treatment, anticholinergics, has many side effects and is sometimes ineffective. Neurostimulation of the posterior tibial nerve is a validated 3rd-line therapy, after failure of perineal re-education and medication. Studies on TENS have shown a real impact on patients quality of life and encourage its use in routine clinical practice. TENSI+ medical device is a treatment for overactive bladder. It is non-invasive, placed over the posterior tibial nerve pathway and sends electrical stimulation via electrodes located on the skin. Discreet and without side effects for users, this treatment is indicated as 3rd-line treatment for people suffering from idiopathic overactive bladder with no contraindications. The aim of this study is to assess the quality of life of patients using this device, both before use and after at least 3 months of use.
- Conditions
- Overactive Bladder
- Being tested
- Survey
- Keywords
- neurostimulation
- 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.
SurveyOther
quality of life questionnaire
| Study group | Role | What they receive |
|---|---|---|
| Overactive bladder TENSI+ patients | Patients monitored for overactive bladder and using the TENSI + device for at least 3 months Receives: Other: Survey |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of quality of life in patients who received treatment correctly treatment with TENSI +
Comparison of patients' quality of life with the OAB-q questionnaire after the installation of this therapy with patients' quality of life before the introduction of this therapy
Measured: Comparison before/after 3 month at least of TENS use
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2024
- Study start29 Mar 2024
- Primary completion26 Apr 2024
- Study completion17 Jun 2024
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
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hopital Nord Franche-Comte
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06484023
- Sponsor's protocol ID
- 2024-01
- Acronym
- TENVESI
- Status last verified
- Jun 2024
- First submitted
- 24 Jun 2024
- Last updated
- 3 Jul 2024
- 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 3 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Place and Efficacy of Treatment With Posterior Tibial Transcutaneous Neurostimulation in Women With Idiopathic Overactive Bladder
- ClinicalTrials.gov ID
- NCT06484023
- Acronym / sponsor ID
- TENVESI / 2024-01
- Conditions
- Overactive Bladder
- Keywords
- neurostimulation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Hopital Nord Franche-ComteUniversity, hospital or other
- Study start
- 29 Mar 2024 (actual)
- Primary completion
- 26 Apr 2024 (actual)
- Study completion
- 17 Jun 2024 (actual)
- First posted
- 3 Jul 2024 (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.
Overactive bladder is a clinical diagnosis affecting up to 17% of women. The existing medical treatment, anticholinergics, has many side effects and is sometimes ineffective. Neurostimulation of the posterior tibial nerve is a validated 3rd-line therapy, after failure of perineal re-education and medication. Studies on TENS have shown a real impact on patients quality of life and encourage its use in routine clinical practice. TENSI+ medical device is a treatment for overactive bladder. It is non-invasive, placed over the posterior tibial nerve pathway and sends electrical stimulation via electrodes located on the skin. Discreet and without side effects for users, this treatment is indicated as 3rd-line treatment for people suffering from idiopathic overactive bladder with no contraindications. The aim of this study is to assess the quality of life of patients using this device, both before use and after at least 3 months of use.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Overactive bladder TENSI+ patients | – | Other: SurveyPatients monitored for overactive bladder and using the TENSI + device for at least 3 months |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Age groups
- Adult, Older adult
- Study population
- Patients treated for overactive bladder and using the TENSI+ for at least 3 months
Key inclusion criteria (2 listed)
- Patients treated for overactive bladder
- Patients using the TENSI+ for at least 3 months
Key exclusion criteria (3 listed)
- Neurological disease that may explain overactive bladder
- Patient having received anticholinergic drug treatment during neurostimulation.
- Have one or more contraindications to wearing the device: pacemaker, defibrillator, wearing a mechanical implant near the electrode placement area, ankle joint problems, damaged skin, cognitive impairment.
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 |
|---|---|---|
| Surveyquality of life questionnaire | Other | Overactive bladder TENSI+ patients |
Primary outcome
Assessment of quality of life in patients who received treatment correctly treatment with TENSI +
Time frame: Comparison before/after 3 month at least of TENS use
Comparison of patients' quality of life with the OAB-q questionnaire after the installation of this therapy with patients' quality of life before the introduction of this therapy
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 3 Jul 2024.
- Individual participant dataSharing planned: No
Related trials for Overactive Bladder
Recruiting
Safety and Performance of UCon Patch Electrode
Urinary Incontinence, Urinary Incontinence, Urge
Active, not recruitingPhase 2/3
Examining the Effects of Intra-detrusor Botox at Time of HoLEP in Men With Overactive Bladder Symptoms
Urinary Incontinence, Overactive Bladder Syndrome
Recruiting
UCon Treatment of Overactive Bladder (OAB) in Males
Urinary Incontinence, Urge Incontinence
Active, not recruitingObservational study
Overactive Bladder Symptoms and Urinary Incontinence In Women With Rheumatoid Arthritis
Rheumatoid Arthritis, Rheumatoid Arthritis (RA)
RecruitingObservational study
Predictive Value of Inflammatory Biomarkers for Mirabegron Response in Women With Overactive Bladder
Overactive Bladder (OAB)
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 Hopital Nord Franche-Comte 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 3 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 3 Jul 2024. 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?
Assessment of quality of life in patients who received treatment correctly treatment with TENSI + (time frame: Comparison before/after 3 month at least of TENS use). 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 3 Jul 2024.