Dysport for the treatment of urinary incontinence in patients with NDO
Research type
Research Study
Full title
A PHASE III, MULTICENTRE, RANDOMISED, DOUBLE BLIND, PARALLEL GROUP, PLACEBO CONTROLLED STUDY TO ASSESS THE EFFICACY AND SAFETY OF ONE OR MORE INTRADETRUSOR TREATMENTS OF 600 OR 800 UNITS OF DYSPORT® FOR THE TREATMENT OF URINARY INCONTINENCE IN SUBJECTS WITH NEUROGENIC DETRUSOR OVERACTIVITY DUE TO SPINAL CORD INJURY OR MULTIPLE SCLEROSIS
IRAS ID
201856
Contact name
Pascal Birman
Contact email
Sponsor organisation
Ipsen Innovation
Eudract number
2015-000507-44
Clinicaltrials.gov Identifier
Duration of Study in the UK
4 years, 10 months, 19 days
Research summary
This study will recruit patients with spinal cord injury and Multiple Sclerosis. These are neurological conditions which can affect the detrusor muscle in the bladder causing it to contract too frequently. This condition is called Neurogenic Detrusor Overactivity (NDO). In NDO the frequent contractions of the bladder muscle often leads to severe urinary incontinence (leakage of urine). These patients have tried previous oral medications for urinary incontinence but that did not fully work.
The study drug, Dysport®, was first licensed in the UK in 1990, for the treatment of other conditions, however, it is not yet licensed for the treatment of NDO. Several previous studies have shown that when it is injected into the bladder muscle it is able to relax this muscle which reduces or even stops urinary incontinence. This study is being performed to gather data to confirm that Dysport® is effective and safe and can be licensed for the treatment of urinary incontinence due to NDO.
Patients in this study will be assessed for approximately 2 years. Patients will be randomly assigned to receive either an active dose (600 U or 800 U) of Dysport® or placebo. In subsequent retreatments, all patients will receive either 600 U or 800 U of Dysport®. Participants will need to come to the study clinic several times; the total visits will depend on the number of study treatments the patient requires during their participation. During the visits patients will undergo procedures to evaluate how the study drug is affecting their condition, including assessment of bladder diary, questionnaires, urodynamics (testing bladder pressures), measurement of vital signs, physical examinations, and blood and urine sample collection for laboratory tests.
About 408 patients will take part in this study which is being conducted at about 100 centres internationally.
This study is sponsored by Ipsen Innovation.
REC name
North West - Liverpool Central Research Ethics Committee
REC reference
16/NW/0305
Date of REC Opinion
7 Jul 2016
REC opinion
Further Information Favourable Opinion