Benign Prostatic Hyperplasia
Conditions
Keywords
benign prostatic hyperplasia, Transurethral Resection of Prostate, transurethral enucleation of prostate
Brief summary
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.
Detailed 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.
Interventions
PROCEDUREtransurethral ventral wall of urethra-preserving enucleation of prostate
The patients' ventral wall of the prostate urethra was preserved and enucleation of prostate was performed for the left hyperplasia in the envelop.
PROCEDUREtransurethral prostatic resection
The patients' prostate was resected with the conventional Nesbit TURP
Sponsors
Southwest Hospital, China
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
MALE
Age
45 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
* BPH was diagnosed by DRE, Ultrasonography, CT or MR * IPSS:\>15 * Qmax:≤10ml/s and volume of bladder \>200ml * The weight of prostate \>45g
Exclusion criteria
* Patient with other aggravating malignant tumor * Total-PSA\>20ng/ml, or 4\<total-PSA\<20ng/ml but the value of Free-PSA/total-PSA\<0.16 * The maximum press of detrusor muscle \<15cmH2O * Patient with urethral stricture * Patient with urinary infection * Patient with Nervous System Disease * Patient with surgical contraindication, such as severe cardiac or lung disease, diaphragmatic hernias, and so on
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| urodynamic study | before operation and the third month, 6th month after operation |
Countries
China
Outcome results
None listed