Overactive BladderVESIC@HOMENCT07379372
Bladder Overactivity and Post-Botulinum Toxin Telemonitoring
A study testing home care in people with Overactive Bladder, run by University Hospital, Grenoble.
Trial summary
Prospective, randomized, controlled, single-center study to compare the feasibility of home monitoring for patients receiving intradetrusor botulinum toxin injections with that of the usual hospital-based follow-up. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Overactive Bladder
- What is being tested?
- home care
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 112 participants
- Where
- No sites listed yet
- Study dates
- 2 Mar 2026to 2 Mar 2031
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient with a neurogenic bladder or idiopathic overactive bladder.
- Patient treated with intradetrusor botulinum toxin injection as part of their usual care, whether performing spontaneous voiding or self-catheterization.
- Patient whose residence allows a home visit by a service provider within the area covered by the AGIR à dom group.
- Patient affiliated with the social security system.
- Patient willing to provide informed consent
Who cannot join
- Persons covered under Articles L1121-5 to L1121-8 of the French Public Health Code (CSP), corresponding to all protected persons: pregnant or postpartum women, breastfeeding mothers, individuals deprived of liberty by judicial or administrative decision, persons receiving psychiatric care under Articles L. 3212-1 and L. 3213-1 who are not covered by the provisions of Article L. 1121-8, individuals admitted to a healthcare or social facility for purposes other than research, minors, persons under legal protection, or individuals unable to give consent.
- Staff members with a hierarchical relationship with the principal investigator.
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: Bladder Overactivity and Post-Botulinum Toxin Telemonitoring: a Randomized, Controlled, Superiority Trial
Prospective, randomized, controlled, single-center study to compare the feasibility of home monitoring for patients receiving intradetrusor botulinum toxin injections with that of the usual hospital-based follow-up.
Read the detailed description
Overactive bladder (OAB) affects seventeen percent of the French population and is characterized by a sudden urge to urinate, urinary frequency, with or without incontinence.
Botulinum toxin, injected into the bladder every 6 to 12 months, is an effective treatment. In 2022, more than 10,000 injections were performed in France (ATIH data). At the Grenoble University Hospital (CHUGA), 190 injections were recorded in 2018 and 300 in 2023. As elsewhere, the active patient cohort is increasing exponentially.
Treatment efficacy is assessed using a voiding diary (VD): a three-day record of each voiding episode with bladder capacity, frequency, and leakage. It is essential to detect the onset of voiding dysfunction through uroflowmetry and ultrasound measurement of post-void residual (PVR) at 6 weeks after injection (peak diffusion and efficacy). This allows determining the dose and frequency of reinjections. The goal is to improve quality of life, but also to protect the upper urinary tract, particularly in neurogenic bladders.
These 300 annual injections require 300 follow-up consultations, but many data points are often missing. Indeed, patients currently often attend post-injection consultations without a voiding diary and with a non-empty bladder… It is therefore important to improve this follow-up.
With our VESIC@HOME project, we aim to provide patients with the services of the home-care provider IC@dom and, thanks to suitable connected tools (Homeflow®), collect VD and uroflowmetry/PVR at home, as well as quality-of-life questionnaires, thereby improving data completeness under more physiological and comfortable conditions for the patient.
- Conditions
- Overactive Bladder
- Being tested
- home care
- Keywords
- urinary incontinence, botulinum toxin, connected urinary incontinence
- Medical subject headings
- Urinary Bladder, Overactive, Urinary Incontinence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
home careOther
6-week follow-up visit: At home (The service provider will bring the necessary equipment for the various measurements and the questionnaires, and will explain their use to the patient. The provider will return to collect the equipment and perform a post-void residual (PVR) measurement 72 hours later.)
| Study group | Role | What they receive |
|---|---|---|
| hospital based follow-up | No intervention | The patient must arrive with a full bladder (a minimum volume of 150 mL, including both the voided volume and the post-void residual), refrain from voiding until urinating into the uroflowmeter, have completed their bladder diary at home beforehand (measuring with a graduated container over 3 days and 3 nights), have filled out the EQ-5D-5L (quality of life), USP (urinary symptoms), and PGI (post-treatment global impression of improvement) questionnaires, and bring them along |
| home based follow-up group | Experimental | A nurse from the provider will bring the equipment required for the different measurements (Homeflow®) and explain its use to the patient. The nurse will also give the patient the EQ-5D-5L (quality of life), USP (urinary symptoms), and PGI (post-treatment global impression of improvement) questionnaires in paper format. A first assessment of the PVR may already be performed. The nurse will return to collect the equipment and questionnaires and to perform a PVR measurement 72 hours later. The recorded data are transmitted directly to the physician, who can view them on their computer (a dedicated secure application provided with the Homeflow solution) and export them in PDF format to add them to the patient's file." Receives: Other: home care |
What is being measured
The primary outcome is the main question the study is designed to answer.
To compare the feasibility of home follow-up in patients receiving intradetrusor botulinum toxin injections with that of the usual hospital-based follow-up
Rate of completeness of data collected at home compared with data collected in the hospital setting.
To be considered complete, the data must include:
The 3-day/3-night bladder diary (including the time and volume of each void); a diary is considered complete even if 3 measurements over the 72-hour period are missing (this accounts for possible patient appointments).
The urinary symptom questionnaire (Urinary Symptom Profile, USP);
Uroflowmetry and post-void residual measurements (only for patients who do not perform intermittent self-catheterization).
All of these data are necessary to address the objective. We cannot separate them, as they serve the same objective.
Measured: at 8 weeks
Secondary outcomes (4)
Compare urinary symptoms according to the type of follow-up.
USP (urinary symptoms profil) questionnaire score at 6-8 weeks post-injection. Score ranging from 0 to 33; the higher the score, the more incontinent the patient is.
Measured: at 8 weeks
Compare functional outcomes ( Normal bladder emptying with not significant post-void residual) according to the type of follow-up in patients with spontaneous voiding.
Uroflowmetry results and post-void residual (PVR) at 6-8 weeks post-injection both criteria are required to evaluate the same outcome
Measured: at 8 weeks
Compare complications according to the type of follow-up.
Adverse events occurring up to 6-8 weeks post-injection: urinary retention requiring self- or caregiver catheterization, symptomatic urinary tract infection with or without fever.
Measured: at 8 weeks
Compare overall quality of life according to the type of follow-up.
EQ-5D-5L scale at 6-8 weeks post-injection.
Measured: at 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2026
- Study start2 Mar 2026 (estimated)
- Primary completion2 Mar 2026 (estimated)
- Study completion2 Mar 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Overactive BladderStudies 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- prospective, randomized and controlled study
- Masking
- None (open label)
- Enrolment
- 112 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- caroline ct thuillier, physician, Principal investigator, university grenoble hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07379372
- Sponsor's protocol ID
- 38RC24.0402
- Acronym
- VESIC@HOME
- Status last verified
- Dec 2025
- First submitted
- 19 Dec 2025
- Last updated
- 30 Jan 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 30 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bladder Overactivity and Post-Botulinum Toxin Telemonitoring: a Randomized, Controlled, Superiority Trial
- ClinicalTrials.gov ID
- NCT07379372
- Acronym / sponsor ID
- VESIC@HOME / 38RC24.0402
- Conditions
- Overactive Bladder
- Keywords
- urinary incontinence, botulinum toxin, connected urinary incontinence
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 112 participants (estimated)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Study start
- 2 Mar 2026 (estimated)
- Primary completion
- 2 Mar 2026 (estimated)
- Study completion
- 2 Mar 2031 (estimated)
- First posted
- 30 Jan 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.
Prospective, randomized, controlled, single-center study to compare the feasibility of home monitoring for patients receiving intradetrusor botulinum toxin injections with that of the usual hospital-based follow-up.
Detailed description
Overactive bladder (OAB) affects seventeen percent of the French population and is characterized by a sudden urge to urinate, urinary frequency, with or without incontinence.
Botulinum toxin, injected into the bladder every 6 to 12 months, is an effective treatment. In 2022, more than 10,000 injections were performed in France (ATIH data). At the Grenoble University Hospital (CHUGA), 190 injections were recorded in 2018 and 300 in 2023. As elsewhere, the active patient cohort is increasing exponentially.
Treatment efficacy is assessed using a voiding diary (VD): a three-day record of each voiding episode with bladder capacity, frequency, and leakage. It is essential to detect the onset of voiding dysfunction through uroflowmetry and ultrasound measurement of post-void residual (PVR) at 6 weeks after injection (peak diffusion and efficacy). This allows determining the dose and frequency of reinjections. The goal is to improve quality of life, but also to protect the upper urinary tract, particularly in neurogenic bladders.
These 300 annual injections require 300 follow-up consultations, but many data points are often missing. Indeed, patients currently often attend post-injection consultations without a voiding diary and with a non-empty bladder… It is therefore important to improve this follow-up.
With our VESIC@HOME project, we aim to provide patients with the services of the home-care provider IC@dom and, thanks to suitable connected tools (Homeflow®), collect VD and uroflowmetry/PVR at home, as well as quality-of-life questionnaires, thereby improving data completeness under more physiological and comfortable conditions for the patient.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- prospective, randomized and controlled study
| Arm | Type | Receives |
|---|---|---|
| hospital based follow-up | No intervention | –The patient must arrive with a full bladder (a minimum volume of 150 mL, including both the voided volume and the post-void residual), refrain from voiding until urinating into the uroflowmeter, have completed their bladder diary at home beforehand (measuring with a graduated container over 3 days and 3 nights), have filled out the EQ-5D-5L (quality of life), USP (urinary symptoms), and PGI (post-treatment global impression of improvement) questionnaires, and bring them along |
| home based follow-up group | Experimental | Other: home careA nurse from the provider will bring the equipment required for the different measurements (Homeflow®) and explain its use to the patient. The nurse will also give the patient the EQ-5D-5L (quality of life), USP (urinary symptoms), and PGI (post-treatment global impression of improvement) questionnaires in paper format. A first assessment of the PVR may already be performed. The nurse will return to collect the equipment and questionnaires and to perform a PVR measurement 72 hours later. The recorded data are transmitted directly to the physician, who can view them on their computer (a dedicated secure application provided with the Homeflow solution) and export them in PDF format to add them to the patient's file." |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patient with a neurogenic bladder or idiopathic overactive bladder.
- Patient treated with intradetrusor botulinum toxin injection as part of their usual care, whether performing spontaneous voiding or self-catheterization.
- Patient whose residence allows a home visit by a service provider within the area covered by the AGIR à dom group.
- Patient affiliated with the social security system.
- Patient willing to provide informed consent
Key exclusion criteria (2 listed)
- Persons covered under Articles L1121-5 to L1121-8 of the French Public Health Code (CSP), corresponding to all protected persons: pregnant or postpartum women, breastfeeding mothers, individuals deprived of liberty by judicial or administrative decision, persons receiving psychiatric care under Articles L. 3212-1 and L. 3213-1 who are not covered by the provisions of Article L. 1121-8, individuals admitted to a healthcare or social facility for purposes other than research, minors, persons under legal protection, or individuals unable to give consent.
- Staff members with a hierarchical relationship with the principal investigator.
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 |
|---|---|---|
| home care6-week follow-up visit: At home (The service provider will bring the necessary equipment for the various measurements and the questionnaires, and will explain their use to the patient. The provider will return to collect the equipment and perform a post-void residual (PVR) measurement 72 hours later.) | Other | home based follow-up group |
Primary outcome
To compare the feasibility of home follow-up in patients receiving intradetrusor botulinum toxin injections with that of the usual hospital-based follow-up
Time frame: at 8 weeks
Rate of completeness of data collected at home compared with data collected in the hospital setting. To be considered complete, the data must include: The 3-day/3-night bladder diary (including the time and volume of each void); a diary is considered complete even if 3 measurements over the 72-hour period are missing (this accounts for possible patient appointments). The urinary symptom questionnaire (Urinary Symptom Profile, USP); Uroflowmetry and post-void residual measurements (only for patients who do not perform intermittent self-catheterization). All of these data are necessary to address the objective. We cannot separate them, as they serve the same objective.
4 secondary outcomes
Compare urinary symptoms according to the type of follow-up.
Time frame: at 8 weeks
Compare functional outcomes ( Normal bladder emptying with not significant post-void residual) according to the type of follow-up in patients with spontaneous voiding.
Time frame: at 8 weeks
Compare complications according to the type of follow-up.
Time frame: at 8 weeks
Compare overall quality of life according to the type of follow-up.
Time frame: at 8 weeks
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 30 Jan 2026.
- Individual participant dataSharing planned: No
Related trials for Overactive Bladder
Not yet recruitingPhase 4
Behavioral and/or Mirabegron to Treat Urinary Symptoms in Parkinson Disease
Overactive Bladder, Parkinson Disease
Recruiting
Ambulatory Long Length URodynamics Evaluation
Urology, Urinary Bladder, Overactive
Active, not recruiting
APPROVE Trial: Evaluating a Prescription Digital Therapeutic for Treatment of OAB in Women
Overactive Bladder (OAB), Urinary Urgency
RecruitingObservational study
Tensi+ European Post-Market Clinical Follow-Up
Overactive Bladder
Not yet recruiting
Transcranial Direct Current Stimulation for Neurogenic Overactive Bladder Symptoms Among People With Stroke
Stroke, Neurogenic Overactive Bladder
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.
caroline ct thuillier, physician principal investigator
university grenoble hospital
Questions about this trial
What is this clinical trial studying?
A study testing home care in people with Overactive Bladder, run by University Hospital, Grenoble.
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 5 inclusion and 2 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 30 Jan 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 caroline CT thuillier, physician (0476767453 ext. +33, cthuillier@chu-grenoble.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To compare the feasibility of home follow-up in patients receiving intradetrusor botulinum toxin injections with that of the usual hospital-based follow-up (time frame: at 8 weeks). 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 30 Jan 2026.