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NCT Number: NCT07379372

Bladder Overactivity and Post-Botulinum Toxin Telemonitoring

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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.

Treatment and study plan

Home care

Other

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.)

Primary outcomes

  1. 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.

Secondary outcomes

  1. Compare urinary symptoms according to the type of follow-up.

    Time frame: at 8 weeks

    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.

  2. 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

    Uroflowmetry results and post-void residual (PVR) at 6-8 weeks post-injection both criteria are required to evaluate the same outcome

  3. Compare complications according to the type of follow-up.

    Time frame: at 8 weeks

    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.

  4. Compare overall quality of life according to the type of follow-up.

    Time frame: at 8 weeks

    EQ-5D-5L scale at 6-8 weeks post-injection.

Study contacts

Contact information is provided by the study sponsor or research team.

assilah AB BOUZIT, study co

CONTACT

[email protected]

0476767971 ext. +33

caroline CT thuillier, physician

CONTACT

[email protected]

0476767453 ext. +33

Sponsors and collaborators

Lead sponsor

University Hospital, Grenoble

Other

Registry information

Official study title

Bladder Overactivity and Post-Botulinum Toxin Telemonitoring: a Randomized, Controlled, Superiority Trial

Acronym: VESIC@HOME

Important dates

Study start
2026
Primary completion
2026
Study completion
2031
First posted
Jan 30, 2026
Registry last updated
Jan 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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