Posterior Tibial Transcutaneous Neurostimulation in Idiopathic Overactive Bladder

NCT06484023 | Completed

• 1 other identifier: 2024-01
• Study Type: observational
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

Overactive bladder is a clinical diagnosis affecting up to 17% of women. The existing medical treatment, anticholinergics, has many side effects and is sometimes ineffective. Neurostimulation of the posterior tibial nerve is a validated 3rd-line therapy, after failure of perineal re-education and medication. Studies on TENS have shown a real impact on patients quality of life and encourage its use in routine clinical practice. TENSI+ medical device is a treatment for overactive bladder. It is non-invasive, placed over the posterior tibial nerve pathway and sends electrical stimulation via electrodes located on the skin. Discreet and without side effects for users, this treatment is indicated as 3rd-line treatment for people suffering from idiopathic overactive bladder with no contraindications. The aim of this study is to assess the quality of life of patients using this device, both before use and after at least 3 months of use.

Conditions

Overactive Bladder

Keywords

neurostimulation

Outcome Measures

Primary Outcomes (1)

• Assessment of quality of life in patients who received treatment correctly treatment with TENSI +

  Comparison of patients' quality of life with the OAB-q questionnaire after the installation of this therapy with patients' quality of life before the introduction of this therapy

  Comparison before/after 3 month at least of TENS use

Study Arms (1)

Overactive bladder TENSI+ patients

Patients monitored for overactive bladder and using the TENSI + device for at least 3 months

Other: Survey

Interventions

Survey OTHER

quality of life questionnaire

Overactive bladder TENSI+ patients

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients treated for overactive bladder and using the TENSI+ for at least 3 months

You may qualify if:

• Patients treated for overactive bladder
• Patients using the TENSI+ for at least 3 months

You may not qualify if:

• Neurological disease that may explain overactive bladder
• Patient having received anticholinergic drug treatment during neurostimulation.
• Have one or more contraindications to wearing the device: pacemaker, defibrillator, wearing a mechanical implant near the electrode placement area, ankle joint problems, damaged skin, cognitive impairment.

Sponsors & Collaborators

• Hopital Nord Franche-Comte: lead

Study Sites (1)

Hôpital Nord Franche-Comté

Trévenans, France

Location

MeSH Terms

Conditions

Urinary Bladder, Overactive

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 24, 2024
• First Posted: July 3, 2024
• Study Start: March 29, 2024
• Primary Completion: April 26, 2024
• Study Completion: June 17, 2024
• Last Updated: July 3, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)