Urinary Symptoms After Posterior Tibial Nerve Stimulation

NCT ID: NCT06458491

Last Updated: 2024-06-13

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-03-01
• Study Completion Date: 2024-05-31

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.

Conditions

Posterior Tibial Nerve Stmulation

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

TENSI+ posterior tibial nerve stimulation for overactive bladder

patients who have benefited from treatment with the TENSI+ device in the context of overactive bladder

Evolution of urinary symptoms

Intervention Type: DEVICE

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

Interventions

Evolution of urinary symptoms

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

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Hospices Civils de Lyon

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Department of obstetrics, Femme Mère Enfant Hospital, Lyon, France

Bron, , France

Countries

France

Other Identifiers

69HCL24_0590

Identifier Type: -

Identifier Source: org_study_id