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

18 agosto 2026 aggiornato da: Centre Hospitalier de Roubaix

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

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.

Panoramica dello studio

Stato

Non ancora reclutamento

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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:

  1. To assess the impact of transcutaneous electrical stimulation on autonomic nervous system function in patients with overactive bladder.
  2. To assess the clinical effectiveness of transcutaneous electrical stimulation in patients with overactive bladder.
  3. To assess the clinical effectiveness of transcutaneous electrical stimulation on associated pelvic floor dysfunctions, including anal incontinence, constipation, and genitosexual disorders.
  4. 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.

Tipo di studio

Interventistico

Iscrizione (Stimato)

70

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Backup dei contatti dello studio

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Terapia di supporto
  • Assegnazione: N / A
  • Modello interventistico: Assegnazione di gruppo singolo
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: Women with overactive bladder who have been prescribed transcutaneous electrical stimulation
Altro: heart rate variability assement

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.

Altri nomi:
  • Questionnaires completion
  • visits in hospital

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Heart rate variability
Lasso di tempo: Baseline and Week 12
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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
To assess the impact of transcutaneous electrical stimulation on autonomic nervous system function in patients with overactive bladder.
Lasso di tempo: Baseline and Week 12

Change in the low-frequency power (LF, 0.04-0.15 Hz) of heart rate variability between Week 0 and Week 12, assessed for each of the three evaluation phases:

  • 1 resting phase
  • 2 active stimulation
  • 3 post-stimulation resting phase
Baseline and Week 12
To assess the impact of transcutaneous electrical stimulation on autonomic nervous system function in patients with overactive bladder.
Lasso di tempo: Baseline and Week 12

Change in the High-frequency power (HF, 0.15-0.40 Hz) of heart rate variability between Week 0 and Week 12, assessed for each of the three evaluation phases:

  • 1 resting phase
  • 2 active stimulation
  • 3 post-stimulation resting phase
Baseline and Week 12
To assess the impact of transcutaneous electrical stimulation on autonomic nervous system function in patients with overactive bladder.
Lasso di tempo: Baseline and Week 12
Low Frequency /High Frequency ratio : is calculated by dividing the low-frequency power by the high-frequency power.
Baseline and Week 12
To assess the impact of transcutaneous electrical stimulation on autonomic nervous system function in patients with overactive bladder.
Lasso di tempo: Baseline and Week 12
Root Mean Square of Successive Difference (RMSSD) : it is calculated as the average of the time intervals between successive heartbeats. It is expressed in milliseconds (ms).
Baseline and Week 12
To assess the clinical effectiveness of transcutaneous electrical stimulation in patients with overactive bladder.
Lasso di tempo: Baseline and Week 12
Change in bladder diary parameters between Week 0 and Week 12. The bladder diary is a detailed record completed by the patient, which serves to assess the patient's bladder function.
Baseline and Week 12
To assess the clinical effectiveness of transcutaneous electrical stimulation in patients with overactive bladder.
Lasso di tempo: Baseline and Week 12
Change in the total score and subscale scores of the ICIQ-OAB (International Consultation on Incontinence Questionnaire - Overactive Bladder) self-administered questionnaire between Week 0 and Week 12. The overall score ranges from 0 to 16, where higher values indicate increased symptom severity.
Baseline and Week 12
To assess the clinical effectiveness of transcutaneous electrical stimulation in patients with overactive bladder.
Lasso di tempo: Baseline and Week 12

Change in the total score and subscale scores of the ICIQ-LUTSqol (International Consultation on Incontinence Questionnaire - Lower Urinary Tract Symptoms Quality of Life) self-administered questionnaire between Week 0 and Week 12. The overall score ranges from 19 to 76.

A score of 19 indicates the absolute lowest possible impact. A score of 76 indicates the highest possible level of impact.
Baseline and Week 12
To assess the clinical effectiveness of transcutaneous electrical stimulation on anal incontinence.
Lasso di tempo: Baseline and Week 12

Change in the total score and subscale scores of the anal incontinence questionnaires (Jorge and Wexner) between Week 0 and Week 12.

The overall score ranges from 0 to 20. Score of 0: represents perfect continence Score of 20: represents complete incontinence
Baseline and Week 12
To assess the clinical effectiveness of transcutaneous electrical stimulation on constipation.
Lasso di tempo: Baseline and Week 12

Change in the total score and subscale scores of the ODS (Obstructed Defecation Score) constipation questionnaire between Week 0 and Week 12.

The overall score ranges from 0 to 20. Score of 0 : represents normal defecation Score of 20 : represents severe obstructed defecation
Baseline and Week 12
To assess the clinical effectiveness of transcutaneous electrical genitosexual disorders.
Lasso di tempo: Baseline and Week 12

Change in the total score and subscale scores of the FSFI (Female Sexual Function Index) self-administered questionnaire between Week 0 and Week 12.

The overall score ranges from 2.0 to 36.0 Score of 2.0 : represents absence of sexual activity or the maximum possible degree of sexual difficulty and pain Score of 36.0 : represents perfect sexual function and total freedom from sexual pain or difficulties
Baseline and Week 12
To assess the tolerability of transcutaneous electrical stimulation in patients with overactive bladder.
Lasso di tempo: Baseline and Week 12

Assessment of treatment tolerability using a Likert scale at Week 0 and Week 12.

The total score ranges from 1 to 5. A score of 1 represents the highest level of discomfort experienced by the patient.

A score of 5 represents the highest level of comfort experienced by the patient.
Baseline and Week 12
To assess the tolerability of transcutaneous electrical stimulation in patients with overactive bladder.
Lasso di tempo: Baseline and Week 12

Pain assessment related to the treatment using a visual analog scale at Week 0 and Week 12.

A score of 0 represents no pain experienced by the patient. A score of 10 represents the maximum level of pain experienced by the patient.
Baseline and Week 12

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Centre Hospitalier de Roubaix

Investigatori

  • Investigatore principale: Guillaume Carnaux, physiotherapist specialized in, Centre Hospitalier Roubaix

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

1 ottobre 2026

Completamento primario (Stimato)

1 ottobre 2028

Completamento dello studio (Stimato)

1 ottobre 2028

Date di iscrizione allo studio

Primo inviato

11 agosto 2026

Primo inviato che soddisfa i criteri di controllo qualità

18 agosto 2026

Primo Inserito (Effettivo)

24 agosto 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

24 agosto 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

18 agosto 2026

Ultimo verificato

1 agosto 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • 2025-002
  • ID RCB 2026-A01741-50 (Altro identificatore: ANSM)

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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