Posterior Tibial Nerve StmulationTENSINCT06458491
Urinary Symptoms After Posterior Tibial Nerve Stimulation
An observational study of Posterior Tibial Nerve Stmulation, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
Overactive bladder (OAB) is a common syndrome affecting 7 million people in France, very often of idiopathic origin. Current therapeutic management of OAB primarily involves hygiene and diet rules, patient education, behavioral measures with bladder reprogramming or even perineo-sphincter rehabilitation. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Posterior Tibial Nerve Stmulation
- What is being tested?
- Evolution of urinary symptoms
- Type of treatment
- Medical device
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- 1 Mar 2024to 31 May 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
- No healthy volunteers
- Adult, Older adult
Study population: This study concerns all patients who have benefited from treatment with the TENSI+ device in the context of overactive bladder between April 2023 and February 2024.
Who may be able to join
- women over 18
- patients who have benefited from treatment with the TENSI+ device in the context of overactive bladder
- intervention between April 2023 and February 2024
- person having expressed his non-opposition
Who cannot join
- inability to understand the information given
- person deprived of liberty
- person under guardianship
Trial locations and contacts
1 site in 1 country.
France1 site
Department of obstetrics, Femme Mère Enfant Hospital, Lyon, France
Bron, 69677
About this study
Official title: Evolution of Urinary Symptoms After Use of TENSI+ Posterior Tibial Nerve Stimulation for Overactive Bladder
Overactive bladder (OAB) is a common syndrome affecting 7 million people in France, very often of idiopathic origin.
Current therapeutic management of OAB primarily involves hygiene and diet rules, patient education, behavioral measures with bladder reprogramming or even perineo-sphincter rehabilitation. However, the modalities of this conservative non-drug treatment are poorly defined and there is uncertainty as to their effectiveness.
Read more
In the event of persistent symptoms, the management of OAB is essentially based on the prescription of an anticholinergic medication. The effectiveness of anticholinergics has been established through numerous randomized clinical trials and meta-analyses. But the side effects of anticholinergics are known and some are very common (particularly dry mouth and constipation).
The principle of the posterior tibial nerve stimulation (TNS) by implanted (percutaneous) or adhesive (transcutaneous) electrode is to stimulate the sensory afferent pathways and to ensure negative feedback on the bladder. Posterior tibial nerve stimulation is a non-invasive therapeutic alternative that has demonstrated its effectiveness through numerous clinical studies mainly using a device for percutaneous use with a weekly stimulation session.
TNS is also possible transcutaneously (TENS) with daily 20-minute stimulation of the ankle, in the form of a self-administered treatment at home, over a period of 3 months. This treatment modality seems equivalent to the percutaneous approach.
Given its numerous advantages, the use of TENS is therefore expanding, and is currently recommended by many learned societies (SIFUD, AFU).
In this study, we wish to evaluate the TENSI+ medical device which uses transcutaneous posterior tibial nerve stimulation and which is offered in routine practice to patients with idiopathic or neurological overactive bladder.
- Conditions
- Posterior Tibial Nerve Stmulation
- Being tested
- Evolution of urinary symptoms
- Keywords
- overactive bladder, Posterior Tibial Nerve Stmulation
- 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.
Evolution of urinary symptomsDevice
Evolution of urinary symptoms 3 months after the start of use of the TENSI+ device
| Study group | Role | What they receive |
|---|---|---|
| TENSI+ posterior tibial nerve stimulation for overactive bladder | patients who have benefited from treatment with the TENSI+ device in the context of overactive bladder Receives: Device: Evolution of urinary symptoms |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evolution of urinary symptoms
change in the "overactive bladder" score obtained by the USP questionnaire
Measured: 3 months after the start of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2024
- Study start1 Mar 2024
- Primary completion30 Apr 2024
- Study completion31 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Posterior Tibial Nerve StmulationStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- 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
- Retrospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06458491
- Sponsor's protocol ID
- 69HCL24_0590
- Acronym
- TENSI
- Status last verified
- Jun 2024
- First submitted
- 10 Jun 2024
- Last updated
- 13 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evolution of Urinary Symptoms After Use of TENSI+ Posterior Tibial Nerve Stimulation for Overactive Bladder
- ClinicalTrials.gov ID
- NCT06458491
- Acronym / sponsor ID
- TENSI / 69HCL24_0590
- Conditions
- Posterior Tibial Nerve Stmulation
- Keywords
- overactive bladder, Posterior Tibial Nerve Stmulation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 1 Mar 2024 (actual)
- Primary completion
- 30 Apr 2024 (actual)
- Study completion
- 31 May 2024 (actual)
- First posted
- 13 Jun 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 (OAB) is a common syndrome affecting 7 million people in France, very often of idiopathic origin.
Current therapeutic management of OAB primarily involves hygiene and diet rules, patient education, behavioral measures with bladder reprogramming or even perineo-sphincter rehabilitation. However, the modalities of this conservative non-drug treatment are poorly defined and there is uncertainty as to their effectiveness.
In the event of persistent symptoms, the management of OAB is essentially based on the prescription of an anticholinergic medication. The effectiveness of anticholinergics has been established through numerous randomized clinical trials and meta-analyses. But the side effects of anticholinergics are known and some are very common (particularly dry mouth and constipation).
The principle of the posterior tibial nerve stimulation (TNS) by implanted (percutaneous) or adhesive (transcutaneous) electrode is to stimulate the sensory afferent pathways and to ensure negative feedback on the bladder. Posterior tibial nerve stimulation is a non-invasive therapeutic alternative that has demonstrated its effectiveness through numerous clinical studies mainly using a device for percutaneous use with a weekly stimulation session.
TNS is also possible transcutaneously (TENS) with daily 20-minute stimulation of the ankle, in the form of a self-administered treatment at home, over a period of 3 months. This treatment modality seems equivalent to the percutaneous approach.
Given its numerous advantages, the use of TENS is therefore expanding, and is currently recommended by many learned societies (SIFUD, AFU).
In this study, we wish to evaluate the TENSI+ medical device which uses transcutaneous posterior tibial nerve stimulation and which is offered in routine practice to patients with idiopathic or neurological overactive bladder.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TENSI+ posterior tibial nerve stimulation for overactive bladder | – | Device: Evolution of urinary symptomspatients who have benefited from treatment with the TENSI+ device in the context of overactive bladder |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This study concerns all patients who have benefited from treatment with the TENSI+ device in the context of overactive bladder between April 2023 and February 2024.
Key inclusion criteria (4 listed)
- women over 18
- patients who have benefited from treatment with the TENSI+ device in the context of overactive bladder
- intervention between April 2023 and February 2024
- person having expressed his non-opposition
Key exclusion criteria (3 listed)
- inability to understand the information given
- person deprived of liberty
- person under guardianship
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 |
|---|---|---|
| Evolution of urinary symptomsEvolution of urinary symptoms 3 months after the start of use of the TENSI+ device | Device | TENSI+ posterior tibial nerve stimulation for overactive bladder |
Primary outcome
Evolution of urinary symptoms
Time frame: 3 months after the start of treatment
change in the "overactive bladder" score obtained by the USP questionnaire
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 13 Jun 2024.
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 Posterior Tibial Nerve Stmulation, run by Hospices Civils de Lyon 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 4 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 13 Jun 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?
Evolution of urinary symptoms (time frame: 3 months after the start of treatment). 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 13 Jun 2024.