Health TrialsbyHealthPanel

Bladder Overactivity and Post-Botulinum Toxin Telemonitoring

ConditionOveractive Bladder
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity Hospital, Grenoble

About this 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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 design

Design model

Parallel

Treatments tested in this trial

  • home care

    Other intervention

    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.)

Treatment groups

112 Participants
are divided into 2 treatment groups
Group A: hospital based follow-upNo intervention 0 interventions
Group B: home based follow-up groupExperimental treatment 1 intervention

Trial outcomes

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.

Time frame
at 8 weeks

Secondary outcomes

1

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.

Time frame
at 8 weeks
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.

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

Time frame
at 8 weeks
3

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.

Time frame
at 8 weeks
4

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

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

Time frame
at 8 weeks

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University Hospital, Grenoble

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: