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

NCT07781033 | Not Yet Recruiting

• 2 other identifiers: 2025-002ID RCB 2026-A01741-50
• Study Type: interventional
• Target: 70
• Locations: 0 countries
• Sites: N/A

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

Overactive Bladder (OAB)

Keywords

overactive bladder; transcutaneous electrical stimulation therapies; TTNS; AOB

Outcome Measures

Primary Outcomes (1)

• Heart rate variability

  The primary outcome measure is the change in SDNN (Standard Deviation of Normal-to-Normal intervals, expressed in ms), a time marker of heart rate variability , between the initial measurement session (Week 0) and the final measurement session (Week 12)

  Baseline and Week 12

Secondary Outcomes (12)

• To assess the impact of transcutaneous electrical stimulation on autonomic nervous system function in patients with overactive bladder.

  Baseline and Week 12

• To assess the impact of transcutaneous electrical stimulation on autonomic nervous system function in patients with overactive bladder.

  Baseline and Week 12

• To assess the impact of transcutaneous electrical stimulation on autonomic nervous system function in patients with overactive bladder.

  Baseline and Week 12

• To assess the impact of transcutaneous electrical stimulation on autonomic nervous system function in patients with overactive bladder.

  Baseline and Week 12

• To assess the clinical effectiveness of transcutaneous electrical stimulation in patients with overactive bladder.

  Baseline and Week 12

Study Arms (1)

Women with overactive bladder who have been prescribed transcutaneous electrical stimulation

EXPERIMENTAL

Other: heart rate variability assement

Interventions

heart rate variability assement OTHER

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. These interventions are performed specifically as part of the study and are not part of routine care.

Also known as: Questionnaires completion, visits in hospital

Women with overactive bladder who have been prescribed transcutaneous electrical stimulation

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Centre Hospitalier de Roubaix: lead

MeSH Terms

Conditions

Urinary Bladder, Overactive

Interventions

Hospitals

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)

Health Facilities; Health Care Facilities Workforce and Services

Study Officials

• Guillaume Carnaux, physiotherapist specialized in

  Centre Hospitalier Roubaix

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Camille Trouillet, Clinical research associate

CONTACT

00320993131; camille.trouillet@ch-roubaix.fr

Maxence Mokeddem, Clinical research associate

CONTACT

00320993131; maxence.mokeddem@ch-roubaix.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 11, 2026
• First Posted: August 24, 2026
• Study Start (Estimated): October 1, 2026
• Primary Completion (Estimated): October 1, 2028
• Study Completion (Estimated): October 1, 2028
• Last Updated: August 24, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share