A randomised placebo-controlled study of Tamsulosin, Voltarol and the combination in types IIIa and IIIb prostatitis using the newly developed and validated National Institutes of Health (NIH) symptom score
| ISRCTN | ISRCTN46815629 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN46815629 |
| Protocol serial number | N0544074138 |
| Sponsor | Department of Health (UK) |
| Funder | Cambridge Consortium - Addenbrooke's (UK) |
- Submission date
- 12/09/2003
- Registration date
- 12/09/2003
- Last edited
- 03/01/2020
- 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
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Richard Batstone
Scientific
Scientific
Box No 43
Department of Urology
Addenbrooke's NHS Trust
Cambridge
CB2 2QQ
United Kingdom
| Phone | +44 (0)1223 216070 |
|---|---|
| hf@cct.com |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | - |
| Study objectives | Alpha blockers and Voltarol in treating chronic prostatitis |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Urological and Genital Diseases: Prostatitis |
| Intervention | The study is a randomised controlled trial using four arms in the treatment of chronic pelvic pain syndrome in men: 1. Placebo only 2. Tamsulosin 3. Voltarol 4. Tamsulosin and Voltarol The study will require the usual investigations for chronic prostatitis, and then a 6-week randomisation period in one of the four arms of treatment, taking a total of four tablets a day. The main outcome measure will be a reduction in the National Institute of Health Chronic Prostatitis Symptom Index (NIHCPSI), which is a newly produced and validated symptom score for assessing men with this condition. |
| Intervention type | Drug |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Tamsulosin, Voltarol |
| Primary outcome measure(s) |
Not provided at time of registration |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 03/11/2003 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Male |
| Target sample size at registration | 60 |
| Key inclusion criteria | 60 patients aged between 30 and 50 |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 04/05/2000 |
| Date of final enrolment | 03/11/2003 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Box No 43
Cambridge
CB2 2QQ
United Kingdom
CB2 2QQ
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Editorial Notes
03/01/2020: No publications found, all search options exhausted, study status unverified.
