Transurethral Ventral Wall of Urethra-preserving Enucleation of Prostate

Study Overview
=================
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.

Official Title
-----------------
Transurethral Ventral Wall of Urethra-preserving Enucleation of Prostate

Conditions
-----------------
Benign Prostatic Hyperplasia

Intervention / Treatment
-----------------
* Procedure: transurethral ventral wall of urethra-preserving enucleation of prostate
* Procedure: transurethral prostatic resection


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 45 Years
Maximum Age: 90 Years

Sexes Eligible for Study
-----------------
Male

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: transurethral prostatic resection<br>The patients' prostate was resected with the conventional Nesbit TURP. | Procedure: transurethral prostatic resection<br>* The patients' prostate was resected with the conventional Nesbit TURP<br>* Other names: TURP;|
| Experimental: ventral wall of urethra-preserving enucleation of prostate<br>The patients' ventral wall of the prostate urethra was preserved and enucleation of prostate was performed for the left hyperplasia in the envelop. | Procedure: transurethral ventral wall of urethra-preserving enucleation of prostate<br>* The patients' ventral wall of the prostate urethra was preserved and enucleation of prostate was performed for the left hyperplasia in the envelop.<br>* Other names: TUEP;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| urodynamic study |  | before operation and the third month, 6th month after operation | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
benign prostatic hyperplasia, Transurethral Resection of Prostate, transurethral enucleation of prostate