Overactive Bladder (OAB)StimHAVNCT07781033
Impact of Transcutaneous Electrical Nerve Stimulation on the Autonomic Nervous System in the Treatment of Overactive Bladder
A study testing heart rate variability assement in people with Overactive Bladder (OAB), run by Centre Hospitalier de Roubaix.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Overactive Bladder (OAB)
- What is being tested?
- heart rate variability assement
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2026to 1 Oct 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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)
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 :
Read more
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.
Read the detailed description
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.
- Conditions
- Overactive Bladder (OAB)
- Being tested
- heart rate variability assement
- Keywords
- overactive bladder, transcutaneous electrical stimulation therapies, TTNS, AOB
- Medical subject headings
- Urinary Bladder, Overactive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
heart rate variability assementOther
Also called Questionnaires completion, visits in hospital
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.
| Study group | Role | What they receive |
|---|---|---|
| Women with overactive bladder who have been prescribed transcutaneous electrical stimulation | Experimental | Not described Receives: Other: heart rate variability assement |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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.
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
Measured: Baseline and Week 12
To assess the impact of transcutaneous electrical stimulation on autonomic nervous system function in patients with overactive bladder.
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
Measured: Baseline and Week 12
To assess the impact of transcutaneous electrical stimulation on autonomic nervous system function in patients with overactive bladder.
Low Frequency /High Frequency ratio : is calculated by dividing the low-frequency power by the high-frequency power.
Measured: Baseline and Week 12
To assess the impact of transcutaneous electrical stimulation on autonomic nervous system function in patients with overactive bladder.
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).
Measured: Baseline and Week 12
To assess the clinical effectiveness of transcutaneous electrical stimulation in patients with overactive bladder.
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.
Measured: Baseline and Week 12
To assess the clinical effectiveness of transcutaneous electrical stimulation in patients with overactive bladder.
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.
Measured: Baseline and Week 12
To assess the clinical effectiveness of transcutaneous electrical stimulation in patients with overactive bladder.
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.
Measured: Baseline and Week 12
To assess the clinical effectiveness of transcutaneous electrical stimulation on anal incontinence.
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
Measured: Baseline and Week 12
To assess the clinical effectiveness of transcutaneous electrical stimulation on constipation.
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
Measured: Baseline and Week 12
To assess the clinical effectiveness of transcutaneous electrical genitosexual disorders.
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
Measured: Baseline and Week 12
To assess the tolerability of transcutaneous electrical stimulation in patients with overactive bladder.
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.
Measured: Baseline and Week 12
To assess the tolerability of transcutaneous electrical stimulation in patients with overactive bladder.
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.
Measured: Baseline and Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2026
- Study start1 Oct 2026 (estimated)
- Primary completion1 Oct 2028 (estimated)
- Study completion1 Oct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Overactive Bladder (OAB)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier de Roubaix
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Guillaume Carnaux, physiotherapist specialized in, Principal investigator, Centre Hospitalier Roubaix
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07781033
- Sponsor's protocol ID
- 2025-002
- Other IDs
- ID RCB 2026-A01741-50
- Acronym
- StimHAV
- Status last verified
- Aug 2026
- First submitted
- 11 Aug 2026
- Last updated
- 24 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT07781033
- Acronym / sponsor ID
- StimHAV / 2025-002
- Conditions
- Overactive Bladder (OAB)
- Keywords
- overactive bladder, transcutaneous electrical stimulation therapies, TTNS, AOB
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Centre Hospitalier de RoubaixUniversity, hospital or other
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- 1 Oct 2028 (estimated)
- Study completion
- 1 Oct 2028 (estimated)
- First posted
- 24 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Women with overactive bladder who have been prescribed transcutaneous electrical stimulation | Experimental | Other: heart rate variability assement |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| heart rate variability assementAlso: Questionnaires completion, visits in hospitalParticipants 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. | Other | Women with overactive bladder who have been prescribed transcutaneous electrical stimulation |
Primary outcome
Heart rate variability
Time frame: 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)
12 secondary outcomes
To assess the impact of transcutaneous electrical stimulation on autonomic nervous system function in patients with overactive bladder.
Time frame: Baseline and Week 12
To assess the impact of transcutaneous electrical stimulation on autonomic nervous system function in patients with overactive bladder.
Time frame: Baseline and Week 12
To assess the impact of transcutaneous electrical stimulation on autonomic nervous system function in patients with overactive bladder.
Time frame: Baseline and Week 12
To assess the impact of transcutaneous electrical stimulation on autonomic nervous system function in patients with overactive bladder.
Time frame: Baseline and Week 12
To assess the clinical effectiveness of transcutaneous electrical stimulation in patients with overactive bladder.
Time frame: Baseline and Week 12
To assess the clinical effectiveness of transcutaneous electrical stimulation in patients with overactive bladder.
Time frame: Baseline and Week 12
To assess the clinical effectiveness of transcutaneous electrical stimulation in patients with overactive bladder.
Time frame: Baseline and Week 12
To assess the clinical effectiveness of transcutaneous electrical stimulation on anal incontinence.
Time frame: Baseline and Week 12
To assess the clinical effectiveness of transcutaneous electrical stimulation on constipation.
Time frame: Baseline and Week 12
To assess the clinical effectiveness of transcutaneous electrical genitosexual disorders.
Time frame: Baseline and Week 12
To assess the tolerability of transcutaneous electrical stimulation in patients with overactive bladder.
Time frame: Baseline and Week 12
To assess the tolerability of transcutaneous electrical stimulation in patients with overactive bladder.
Time frame: Baseline and Week 12
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Guillaume Carnaux, physiotherapist specialized in principal investigator
Centre Hospitalier Roubaix
Questions about this trial
What is this clinical trial studying?
A study testing heart rate variability assement in people with Overactive Bladder (OAB), run by Centre Hospitalier de Roubaix.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 24 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Camille Trouillet, Clinical research associate (00320993131, camille.trouillet@ch-roubaix.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Heart rate variability (time frame: Baseline and Week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2026.