Condition category
Urological and Genital Diseases
Date applied
05/07/2006
Date assigned
21/07/2006
Last edited
12/05/2011
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

www.bui.ac.uk

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

  1. 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.

Additional files

Editorial Notes