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OpenTrials
Completed

NCT Number: NCT06458491

Urinary Symptoms After Posterior Tibial Nerve Stimulation

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.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Evolution of urinary symptoms

Device

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

Primary outcomes

  1. Evolution of urinary symptoms

    Time frame: 3 months after the start of treatment

    change in the "overactive bladder" score obtained by the USP questionnaire

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Official study title

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

Acronym: TENSI

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Jun 13, 2024
Registry last updated
Jun 13, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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