Contact information
Type
Scientific
Primary contact
Prof Paul Abrams
ORCID ID
Contact details
Bristol Urological Institute
Southmead Hospital
Bristol
BS10 5NB
United Kingdom
+44 (0) 117 959 5690
paul_abrams@bui.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
QLK3-CT-2001-00987
Study information
Scientific title
Acronym
ACTION
Study hypothesis
Overactive bladder syndrome (OAB) is a symptom complex consisting of urgency, urgency incontinence (UUI), frequency and nocturia. This study looked at whether oral desmopressin, by decreasing urine production by the kidneys, would prolong bladder filling time thereby increasing the time to reach maximum capacity, thus reducing Overactive Bladder (OAB) symptoms, and providing an alternative method of treatment to OAB sufferers.
Ethics approval
Ethical approval by the Southmead Local Ethics Research Committee was recieved 23/01/2004.
Study design
Two-week, multi-national, multi-centre, phase IIb, double blind, prospective, randomised, cross-over, placebo controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Other
Trial type
Treatment
Patient information sheet
Condition
Overactive bladder syndrome (OAB)
Intervention
0.2 mg oral desmopressin tablets versus placebo.
Intervention type
Drug
Phase
Phase II
Drug names
Desmopressin
Primary outcome measures
1. Evaluation of effectiveness of desmopressin in increasing the time to first unwanted event, in patients with overactive bladder, in the first eight hours of the day, following treatment.
2. Evaluation of the effect of desmopressin on quality of life in patients with overactive bladder syndrome using the International Confrontation on Incontinence (ICI) OAB short form questionnaire.
Secondary outcome measures
Evaluation of effectiveness of desmopressin by decreasing the average number of unwanted events (micturitions, incontinence episodes, urgency episode), during the first eight hours of the day, following treatment.
Overall trial start date
03/05/2004
Overall trial end date
14/07/2005
Reason abandoned
Eligibility
Participant inclusion criteria
Male and female patients 18 years of age or older with overactive bladder syndrome if they have an average of four or more voids in the first eight hours of the day (excluding the first void in the morning) and/or more than one incontinence episode in the first eight hours of the day during the seven days screening period.
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
90
Participant exclusion criteria
1. Consistent residual volume >150 ml
2. Abnormal levels of serum/plasma sodium
3. Newly started Benign Prostatic Hypertrophy (BPH) medical/surgical treatment
4. Diabetes insipidus/primary polydipsia
5. Multiple sclerosis
6. Stress urinary incontinence
7. Pelvic organ prolapse
Recruitment start date
03/05/2004
Recruitment end date
14/07/2005
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Bristol Urological Institute
Bristol
BS10 5NB
United Kingdom
Sponsor information
Organisation
Bristol Urological Institute (UK)
Sponsor details
Bristol Urological Institute
Southmead Hospital
Bristol
BS10 5NB
United Kingdom
+44 (0) 117 959 5690
paul_abrams@bui.ac.uk
Sponsor type
University/education
Website
Funders
Funder type
Government
Funder name
European Union (Belgium) - Grant (ref: QLK3-CT-2001-00987)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
2009 results in http://www.ncbi.nlm.nih.gov/pubmed/18726947
Publication citations
-
Results
Hashim H, Malmberg L, Graugaard-Jensen C, Abrams P, Desmopressin, as a "designer-drug," in the treatment of overactive bladder syndrome., Neurourol. Urodyn., 2009, 28, 1, 40-46, doi: 10.1002/nau.20613.