Transurethral Ventral Wall of Urethra-preserving Enucleation of Prostate
This trial is active, not recruiting.
|Condition||benign prostatic hyperplasia|
|Treatments||transurethral ventral wall of urethra-preserving enucleation of prostate, transurethral prostatic resection|
|Sponsor||Southwest Hospital, China|
|Start date||March 2010|
|End date||February 2012|
|Trial size||200 participants|
|Trial identifier||NCT01073241, SouthwestH|
In this study, the investigators designed a randomized and double-blind prospective trial to evaluate the efficiency and safety of the investigators new approach—transurethral ventral wall of urethra-preserving enucleation of prostate in comparison with TURP for the hyperplasia weighing more than 45 g.
|Endpoint classification||safety/efficacy study|
|Intervention model||parallel assignment|
|Masking||double blind (subject, outcomes assessor)|
time frame: before operation and the third month, 6th month after operation
Male participants from 45 years up to 90 years old.
- BPH was diagnosed by DRE, Ultrasonography, CT or MR
- Qmax:≤10ml/s and volume of bladder >200ml
- The weight of prostate >45g
- Patient with other aggravating malignant tumor
- Total-PSA>20ng/ml, or 4
|Official title||Transurethral Ventral Wall of Urethra-preserving Enucleation of Prostate|
|Description||Although in recent dozen of years, laser operation and other safer minimally invasive surgeries have been well-developed, transurethral resection of the prostate (TURP) is still the gold standard for the surgical treatment of benign prostatic hyperplasia, despite of its various complications, and not suitable for the hyperplasia over 80 g which should be resected under open surgery. In this study, we design a randomized and double-blind prospective trial to evaluate the efficiency and safety of our new approach—transurethral ventral wall of urethra-preserving enucleation of prostate in comparison with TURP for the hyperplasia weighing more than 45 g.Urodynamic examination [maximum flow rate (QMax), detrusor pressure, and so on], transrectal color Doppler ultrasonography for the prostate, blood routine, blood electrolyte, prostate specific antigen (PSA), International Prostate Symptom Score (IPSS), the quality of life (Qol), blood loss during operation, and the weight of resected prostate were studied before and after the operation.|
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