Bladder Overactivity and Post-Botulinum Toxin Telemonitoring

Official title

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

Overview

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.

Interventions

• Other home care
  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 outcome measures

• 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]

Secondary outcome measures (4)

• 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]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Supportive care

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07379372 · 38RC24.0402

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗