Randomised evaluation of alternative electrosurgical modalities to treat bladder outflow obstruction in men with benign prostatic hyperplasia (BPH).
| ISRCTN | ISRCTN53810731 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN53810731 |
| Protocol serial number | HTA 94/04/09 |
| Sponsor | Department of Health (UK) |
| Funder | NIHR Health Technology Assessment Programme - HTA (UK) |
- Submission date
- 25/04/2003
- Registration date
- 25/04/2003
- Last edited
- 08/11/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Urological and Genital Diseases
Plain English summary of protocol
Not provided at time of registration
Contact information
Scientific
Academic Urological Unit
The Royal London Hospital
4th Floor
Alexandra Wing
Queen Mary and Westfield College
London
E1 1BB
United Kingdom
| Phone | +44 (0)20 7377 7226 |
|---|---|
| C.G.Fowler@mds.qmw.ac.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | Randomised evaluation of alternative electrosurgical modalities to treat bladder outflow obstruction in men with benign prostatic hyperplasia (BPH). |
| Study objectives | Many of the newer means of treating symptomatic BPH require expensive new equipment which requires significant additional capital investment. We consider that before investing in such equipment we should evaluate cheaper electrosurgical methods which may be similarly efficacious. |
| Ethics approval(s) | Not provided at time of registration. |
| Health condition(s) or problem(s) studied | Urological and genital diseases: Other urological and genital disease |
| Intervention | 1. Transurethral resection of the prostate (TURP) 2. Transurethral diathermy vaporisation of the prostate (TUDVP). Perioperative complications and time to discharge, determined by strictly defined criteria will be compared. |
| Intervention type | Other |
| Primary outcome measure(s) |
The efficacy of the operation will be assessed by symptom scores, urine flow rate studies at two months and one year after surgery. A questionnaire covering adverse events, quality of life, impact on sexual function and customer satisfaction will be administered preoperatively and at each visit by a trained nurse counsellor. This trial will be coordinated and the results analysed for safety, effectiveness and cost benefit in collaboration with the Prostate trials Office (PROTO) at Bristol. |
| Key secondary outcome measure(s) |
Not provided at time of registration. |
| Completion date | 31/07/2001 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Male |
| Target sample size at registration | 530 |
| Key inclusion criteria | 530 men with BPH causing bladder outflow obstruction will be recruited from four centres: one teaching hospital and three district general hospitals. |
| Key exclusion criteria | Not provided at time of registration. |
| Date of first enrolment | 01/06/1996 |
| Date of final enrolment | 31/07/2001 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
E1 1BB
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 | Not provided at time of registration |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | HTA monograph | 01/02/2005 | Yes | No |
Editorial Notes
08/11/2022: Internal review.
