Bladder Overactivity and Post-Botulinum Toxin Telemonitoring

Sponsor
University Hospital, Grenoble
Study ID
NCT07379372
Status
Not Yet Recruiting

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Conditions

  • Overactive Bladder

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 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.)

Study Details

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.

Key Dates

First listed
Jan 30, 2026
Start date
Mar 2, 2026
Status verified
Dec 2025
Primary completion
Mar 2, 2026
Completion
Mar 2, 2031

Study Design

Enrollment
112 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

Arms

  • No Intervention: hospital based follow-up
    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
  • Experimental: home based follow-up group
    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."

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 ]

Central Contacts

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