Impact of Transcutaneous Electrical Nerve Stimulation on the Autonomic Nervous System in the Treatment of Overactive Bladder (StimHAV)
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.
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
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.
Tipo de estudo
Inscrição (Estimado)
Estágio
- Não aplicável
Contactos e Locais
Contato de estudo
- Nome: Camille Trouillet, Clinical research associate
- Número de telefone: 00320993131
- E-mail: camille.trouillet@ch-roubaix.fr
Estude backup de contato
- Nome: Maxence Mokeddem, Clinical research associate
- Número de telefone: 00320993131
- E-mail: maxence.mokeddem@ch-roubaix.fr
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Descrição
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.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Cuidados de suporte
- Alocação: N / D
- Modelo Intervencional: Atribuição de grupo único
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Experimental: Women with overactive bladder who have been prescribed transcutaneous electrical stimulation
|
Participants will:
These interventions are performed specifically as part of the study and are not part of routine care.
Outros nomes:
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Heart rate variability
Prazo: 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
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
To assess the impact of transcutaneous electrical stimulation on autonomic nervous system function in patients with overactive bladder.
Prazo: 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:
|
Baseline and Week 12
|
|
To assess the impact of transcutaneous electrical stimulation on autonomic nervous system function in patients with overactive bladder.
Prazo: 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:
|
Baseline and Week 12
|
|
To assess the impact of transcutaneous electrical stimulation on autonomic nervous system function in patients with overactive bladder.
Prazo: 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.
Prazo: 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.
Prazo: 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.
Prazo: 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.
Prazo: 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.
Prazo: 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.
Prazo: 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.
Prazo: 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.
Prazo: 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.
Prazo: 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
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Guillaume Carnaux, physiotherapist specialized in, Centre Hospitalier Roubaix
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Estimado)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
- Doenças urogenitais
- Doenças Urogenitais Masculinas
- Doenças Urológicas
- Doenças Urogenitais Femininas
- Doenças urogenitais femininas e complicações na gravidez
- Sintomas do Trato Urinário Inferior
- Manifestações Urológicas
- Doenças da Bexiga Urinária
- Condições Patológicas, Sinais e Sintomas
- Sinais e sintomas
- Bexiga Urinária Hiperativa
- Instalações de saúde Força e serviços de trabalho
- Instalações de saúde
- Hospitais
Outros números de identificação do estudo
- 2025-002
- ID RCB 2026-A01741-50 (Outro identificador: ANSM)
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .