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

18. August 2026 aktualisiert von: 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.

Studienübersicht

Status

Noch keine Rekrutierung

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

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.

Studientyp

Interventionell

Einschreibung (Geschätzt)

70

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

Studieren Sie die Kontaktsicherung

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Erwachsene
  • Älterer Erwachsener

Akzeptiert gesunde Freiwillige

Nein

Beschreibung

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.

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Unterstützende Pflege
  • Zuteilung: N / A
  • Interventionsmodell: Einzelgruppenzuweisung
  • Maskierung: Keine (Offenes Etikett)

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: Women with overactive bladder who have been prescribed transcutaneous electrical stimulation
Sonstiges: 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.

Andere Namen:
  • Questionnaires completion
  • visits in hospital

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Heart rate variability
Zeitfenster: 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

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
To assess the impact of transcutaneous electrical stimulation on autonomic nervous system function in patients with overactive bladder.
Zeitfenster: 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.
Zeitfenster: 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.
Zeitfenster: 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.
Zeitfenster: 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.
Zeitfenster: 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.
Zeitfenster: 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.
Zeitfenster: 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.
Zeitfenster: 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.
Zeitfenster: 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.
Zeitfenster: 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.
Zeitfenster: 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.
Zeitfenster: 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

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Centre Hospitalier de Roubaix

Ermittler

  • Hauptermittler: Guillaume Carnaux, physiotherapist specialized in, Centre Hospitalier Roubaix

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Geschätzt)

1. Oktober 2026

Primärer Abschluss (Geschätzt)

1. Oktober 2028

Studienabschluss (Geschätzt)

1. Oktober 2028

Studienanmeldedaten

Zuerst eingereicht

11. August 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

18. August 2026

Zuerst gepostet (Tatsächlich)

24. August 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

24. August 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

18. August 2026

Zuletzt verifiziert

1. August 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • 2025-002
  • ID RCB 2026-A01741-50 (Andere Kennung: ANSM)

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NEIN

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Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

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