An interventional study of heart rate variability assement in Overactive Bladder (OAB), sponsored by Centre Hospitalier de Roubaix. Not yet recruiting. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-24.
Sponsored by Centre Hospitalier de Roubaix · Not applicable, Interventional, and Supportive care
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:
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:
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.
858 studies on the registry are indexed under Urinary Bladder, Overactive; 127 are open to participants now.
This study's planned enrollment of 70 is close to the median of 70 across 649 interventional studies indexed under Urinary Bladder, Overactive.
Browse Urinary Bladder, Overactive studies →Centre Hospitalier de Roubaix is the lead sponsor of 9 studies on the registry; 4 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Other: 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.
Also known as: Questionnaires completion, visits in hospital
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)
Time frame: 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 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
Time frame: 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
Time frame: 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.
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: Baseline and Week 12
No study locations are listed for this record.
Plan to share: No
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Centre Hospitalier de Roubaix