Oral desmopressin for treatment of adults with overactive bladder syndrome
| ISRCTN | ISRCTN61712514 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN61712514 |
| Secondary identifying numbers | QLK3-CT-2001-00987 |
- Submission date
- 05/07/2006
- Registration date
- 21/07/2006
- Last edited
- 12/05/2011
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Urological and Genital Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof Paul Abrams
Scientific
Scientific
Bristol Urological Institute
Southmead Hospital
Bristol
BS10 5NB
United Kingdom
| Phone | +44 (0) 117 959 5690 |
|---|---|
| paul_abrams@bui.ac.uk |
Study information
| 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 |
| Study setting(s) | Other |
| Study type | Treatment |
| Scientific title | |
| Study acronym | ACTION |
| Study objectives | 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(s) | Ethical approval by the Southmead Local Ethics Research Committee was recieved 23/01/2004. |
| Health condition(s) or problem(s) studied | Overactive bladder syndrome (OAB) |
| Intervention | 0.2 mg oral desmopressin tablets versus placebo. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Phase II |
| Drug / device / biological / vaccine name(s) | Desmopressin |
| Primary outcome measure | 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 study start date | 03/05/2004 |
| Completion date | 14/07/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 90 |
| Key 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. |
| Key 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 |
| Date of first enrolment | 03/05/2004 |
| Date of final enrolment | 14/07/2005 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Bristol Urological Institute
Bristol
BS10 5NB
United Kingdom
BS10 5NB
United Kingdom
Sponsor information
Bristol Urological Institute (UK)
University/education
University/education
Bristol Urological Institute
Southmead Hospital
Bristol
BS10 5NB
England
United Kingdom
| Phone | +44 (0) 117 959 5690 |
|---|---|
| paul_abrams@bui.ac.uk | |
| Website | www.bui.ac.uk |
"ROR" |
https://ror.org/036x6gt55 |
Funders
Funder type
Government
European Union (Belgium) - Grant (ref: QLK3-CT-2001-00987)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/06/2009 | Yes | No |
