Impact of Transcutaneous Electrical Nerve Stimulation on the Autonomic Nervous System in the Treatment of Overactive Bladder | NCT07781033 | Trialant

Not yet recruitingInterventionalNot ApplicableUpdated Aug 24, 2026

Impact of Transcutaneous Electrical Nerve Stimulation on the Autonomic Nervous System in the Treatment of Overactive Bladder

Impact of Transcutaneous Electrical Nerve Stimulation on the Autonomic Nervous System in the Treatment of Overactive Bladder: A Prospective, Single-Center Study (StimHAV)

Overview

Key facts that identify this study and show where it stands today.

ClinicalTrials.gov ID: NCT07781033
Lead Sponsor: Centre Hospitalier de RoubaixOTHER
Overall Status: Not yet recruiting
Study Type: Interventional
Phase: Not Applicable
Enrollment: 70Estimated
Last Update Posted: Aug 24, 2026Actual
Start Date: Oct 1, 2026Estimated
Primary Completion Date: Oct 1, 2028Estimated
Completion Date: Oct 1, 2028Estimated

Description

What the study is about and why it is being run, in the researchers' own words.

Official Title: Impact of Transcutaneous Electrical Nerve Stimulation on the Autonomic Nervous System in the Treatment of Overactive Bladder: A Prospective, Single-Center Study (StimHAV)
Brief Summary: The goal of this observational study is to evaluate the impact of Transcutaneous Electrical Nerve Stimulation on the autonomic nervous system in adults women with overactive bladder.

The main question it aims to answer is :

Does Transcutaneous Electrical Nerve Stimulation to treat overactive bladder have an impact on the autonomic nervous system ?

To answer this question, the primary outcome measure will be heart rate variability (HRV) during transcutaneous electrical nerve stimulation therapy

Participants will:

Receive their first and last sessions of transcutaneous electrical nerve stimulation in the hospital.

Complete questionnaires during their first and last transcutaneous electrical nerve stimulation sessions.

Have their heart rate variability measured during their first and last transcutaneous electrical nerve stimulation sessions.

Conditions

The medical conditions and diseases this study investigates.

Overactive Bladder (OAB)

Interventions

The treatments and procedures being evaluated in this study.

heart rate variability assement

Participation

Who can join this study and the criteria used to decide.

Ages Eligible for Study: Adult (18-64)Older Adult (65+)
Sexes Eligible for Study: Female
Accepts Healthy Volunteers: No
Eligibility Criteria: Inclusion Criteria:

Female

Adult patient aged 18 years or older

Clinical diagnosis of overactive bladder made by a urologist or gynecologist with no identified cause

Eligible for transcutaneous tibial nerve stimulation (TTNS) or interferential stimulation (IF) as part of the management of non-neurogenic overactive bladder

Body mass index (BMI) ≤ 30 kg/m²

Able to understand and complete the study questionnaires independently

No objection to participating in the study.

Exclusion Criteria:

Neurogenic overactive bladder.

Local irritative factors, such as bladder stones, bladder tumors, or urinary tract infection.

Previous treatment with transcutaneous tibial nerve stimulation (TTNS).

Previous treatment with interferential stimulation (IF).

Contraindications to electrical stimulation, including: cancer, Pacemaker, Pregnancy, Conductive prosthetic material in the area of stimulation, Heart disease, Epilepsy, Active phlebitis or thrombophlebitis, Skin lesions in the treatment area

Use of anticholinergic medication during the previous three weeks

Objection to participating in the study.

Design

How the study is designed and how its participant groups are organized.

Primary Purpose: Supportive Care
Allocation: N/A
Interventional Model: Single Group Assignment
Masking: None (Open Label)

Contacts

The people to reach with questions about this study or how to join it.

Camille Trouillet, Clinical research associateContact

camille.trouillet@ch-roubaix.fr00320993131

Locations

Where the study is run and whether each site is currently recruiting.

No locations

There are no locations for this study.

Collaborators

The organizations and people involved in this study.

Lead Sponsor: Centre Hospitalier de RoubaixOTHER

Similar Studies

Other registered studies that closely resemble this one.

Rationale :

Overactive bladder (OAB) is a common condition that can have a major impact on quality of life. Transcutaneous peripheral electrical stimulation therapies are a recognized treatment option, but their mechanisms of action are still not fully understood.

Recent data suggest that their effectiveness may be related to changes in the autonomic nervous system. However, no study has yet evaluated this effect in patients with non-neurogenic overactive bladder. This study aims to better understand the physiological mechanisms involved, improve knowledge about these treatments, and contribute to their better use in clinical practice.

Objectives :

Primary objective:

The primary objective of this study is to evaluate the impact of transcutaneous electrical stimulation therapies on the overall balance of the autonomic nervous system in patients with overactive bladder.

Secondary objectives:

To assess the impact of transcutaneous electrical stimulation on autonomic nervous system function in patients with overactive bladder.
To assess the clinical effectiveness of transcutaneous electrical stimulation in patients with overactive bladder.
To assess the clinical effectiveness of transcutaneous electrical stimulation on associated pelvic floor dysfunctions, including anal incontinence, constipation, and genitosexual disorders.
To assess the tolerability of transcutaneous electrical stimulation in patients with overactive bladder.

Study design :

This is a prospective, single-center, observational study conducted in routine clinical practice. It will include female patients with overactive bladder who are receiving transcutaneous peripheral electrical stimulation as part of their usual care.

Study procedure :

After confirmation of the diagnosis of overactive bladder by a specialist physician, patients will be prescribed transcutaneous peripheral electrical stimulation, transcutaneous tibial nerve stimulation (TTNS) or interferential stimulation (IF). They will then be referred to the study investigator for an inclusion visit.

At the initial visit (Week 0), after checking the eligibility criteria and obtaining informed consent, participants will receive pelvic health education and their first electrical stimulation session. Heart rate variability will be recorded using an ECG Holter monitor. Clinical data and study questionnaires will also be collected.

Participants will receive two 72-hour bladder diaries. The first will be completed at the beginning of the study and the second before the final visit.

Treatment will continue for 12 weeks according to the prescribed method: TTNS will be performed at home, IF will be performed in a physiotherapy clinic. A follow-up telephone call will be made at 6 weeks (± 1 week) to assess treatment adherence.

At 12 weeks (± 1 week), participants will attend a final visit. This visit will include an electrical stimulation session with HRV measurement, completion of the follow-up questionnaires, and collection of the final bladder diary.

Data collected at baseline and at 12 weeks will be compared to assess the impact of electrical stimulation therapies on the autonomic nervous system and overactive bladder symptoms.