None listed
Conditions
Interventions
HP749
Sponsors
UroGene SA
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used)
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
History of at least 6 months of OAB symptoms, defined as at least 8 micturitions/day, one urgency with or without incontinence episode (at least one/day) and nocturia (to wake at night > 1 time to void). Patients without medication for OAB, or with ineffective and/or unsatisfactory medication for OAB or with a history of ineffective and/or unsatisfactory medication for OAB are included in the trial (wash-out of 2 weeks is mandatory before base-line period and urodynamic examination). Prerequisites for inclusion are no previous bladder training or no current bladder training if started less than one month prior to the trial. Patients with polyuria, urodynamic stress incontinence, renal disease, or bladder outlet obstruction are excluded from the trial, as are patients having any other disease or condition (including neurological disease that could be linked to OAB symptoms) making them unsuitable for participating to the trial.
Exclusion criteria
No exclusion criteria
Outcome results
None listed