Bladder Overactivity and Post-Botulinum Toxin Telemonitoring

NCT07379372 | Not Yet Recruiting

• 1 other identifier: 38RC24.0402
• Study Type: interventional
• Target: 112
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Overactive Bladder

Keywords

urinary incontinence; botulinum toxin; connected urinary incontinence

Outcome Measures

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

  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.

  at 8 weeks

Secondary Outcomes (4)

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

  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.

  at 8 weeks

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

  at 8 weeks

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

  at 8 weeks

Study Arms (2)

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."

Other: home care

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.)

home based follow-up group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital, Grenoble: lead

MeSH Terms

Conditions

Urinary Bladder, Overactive; Urinary Incontinence

Interventions

Home Care Services

Condition Hierarchy (Ancestors)

Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Urination Disorders

Intervention Hierarchy (Ancestors)

Community Health Services; Health Services; Health Care Facilities Workforce and Services; Nursing Services

Study Officials

• caroline ct thuillier, physician

  university grenoble hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

caroline CT thuillier, physician

CONTACT

0476767453; cthuillier@chu-grenoble.fr

assilah AB BOUZIT, study co

CONTACT

0476767971; abouzit@chu-grenoble.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: prospective, randomized and controlled study

Study Record Dates

• First Submitted: December 19, 2025
• First Posted: January 30, 2026
• Study Start: March 2, 2026
• Primary Completion: March 2, 2026
• Study Completion (Estimated): March 2, 2031
• Last Updated: January 30, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share