Clinical trial NCT06458491: Urinary Symptoms After Posterior Tibial Nerve Stimulation
Official title: Evolution of Urinary Symptoms After Use of TENSI+ Posterior Tibial Nerve Stimulation for Overactive Bladder
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Posterior Tibial Nerve Stmulation
Keywords: overactive bladder
Posterior Tibial Nerve Stmulation
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2024-06-13
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Evolution of urinary symptoms
timeFrame: 3 months after the start of treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Bron
country: France
facility: Department of obstetrics, Femme Mère Enfant Hospital, Lyon, France
Study officials:
References: