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Urinary Symptoms After Posterior Tibial Nerve Stimulation

Evolution of Urinary Symptoms After Use of TENSI+ Posterior Tibial Nerve Stimulation for Overactive Bladder

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06458491
Acronym
TENSI
Enrollment
100
Registered
2024-06-13
Start date
2024-03-01
Completion date
2024-05-31
Last updated
2024-06-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Posterior Tibial Nerve Stmulation

Keywords

overactive bladder, Posterior Tibial Nerve Stmulation

Brief 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. 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.

Interventions

DEVICEEvolution of urinary symptoms

Evolution of urinary symptoms 3 months after the start of use of the TENSI+ device

Sponsors

Hospices Civils de Lyon
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* 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

Exclusion criteria

* inability to understand the information given * person deprived of liberty * person under guardianship

Design outcomes

Primary

MeasureTime frameDescription
Evolution of urinary symptoms3 months after the start of treatmentchange in the overactive bladder score obtained by the USP questionnaire

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026