Randomised evaluation of alternative electrosurgical modalities to treat bladder outflow obstruction in men with benign prostatic hyperplasia (BPH).
Not Applicable
Completed
- Conditions
- rological and genital diseases: Other urological and genital diseaseUrological and Genital DiseasesBladder outflow obstruction
- Registration Number
- ISRCTN53810731
- Lead Sponsor
- Department of Health (UK)
- Brief Summary
2005 Results article in http://www.ncbi.nlm.nih.gov/pubmed/15698525 HTA monograph
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Male
- Target Recruitment
- 530
Inclusion Criteria
530 men with BPH causing bladder outflow obstruction will be recruited from four centres: one teaching hospital and three district general hospitals.
Exclusion Criteria
Not provided at time of registration.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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.
- Secondary Outcome Measures
Name Time Method ot provided at time of registration.