The objective of this study was to compare open surgery with TURP in BPH cases. 200 patients with moderate size BPH who were candidates of surgery were randomly assigned to undergo open prostatectomy or TURP. Transrectal sonography, lab tests, International Prostate Symptom Score (IPSS) and uroflumetry were done for all patients at baseline and follow-up visits. Patients were visited one and 6 month after surgery and uroflumetry and systoscopy were done for them. The results were compared between study groups
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138803181267N13
Registration date:2009-08-24, 1388/06/02
Registration timing:retrospective
Last update:
Update count:0
Registration date
2009-08-24, 1388/06/02
Registrant information
Name
Mojgan Borgheie
Name of organization / entity
Urology and Nephrology Research Center (UNRC), Shahid Beheshti University of Mediacal Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 2256 7222
Email address
research@unrc.ir
Recruitment status
Recruitment complete
Funding source
Urology and Nephrology Research Center ( UNRC), Shahid Beheshti University, M.C.( SBMU), Tehran, I.R. Iran
Expected recruitment start date
2005-11-22, 1384/09/01
Expected recruitment end date
2007-11-22, 1386/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of outcome and complications of open prostatectomy and TURP in treatment of medium- size hypertrophic prostate.
Public title
Comparison of outcome and complications of open prostatectomy and TURP in treatment of medium- size hypertrophic prostate.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Prostate larger than normal and have one of these conditions:1 acute urinary retention more than one time 2.recurrent infection 3. recurrent hematuria 3. azotemia 4. dissatisfaction after treatment 5. absence of bladder stone or diverticule
Exclusion Criteria: 1. bladder stone larger than 2 cm 2. weight of prostate more than 75 grams and less than 30 grams 3. resectable bladder diverticule 4.anclusis and orthopedic problems 5. previous urethra problems 6. hernia 7. suspicious for PSA>4 or suspicious nodule in touch 8. DRE previous prostatectomy 9. others pathology results than BPH
Age
No age limit
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
200
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Urology and Nephrology Research Center ( UNRC), Shahid Beheshti University