Transurethral Ventral Wall of Urethra-preserving Enucleation of Prostate

Benign Prostatic Hyperplasia Clinical Trial

Official title:

Transurethral Ventral Wall of Urethra-preserving Enucleation of Prostate

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01073241
• Other study ID #: SouthwestH
• Status: Active, not recruiting
• Phase: N/A
• First received: February 22, 2010
• Last updated: March 12, 2010
• Start date: March 2010
• Est. completion date: February 2012

Study information

• Verified date: February 2010
• Source: Southwest Hospital, China
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 200
• Est. completion date: February 2012
• Est. primary completion date: February 2012
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 45 Years to 90 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Benign Prostatic Hyperplasia
• Hyperplasia
• Prostatic Hyperplasia

Intervention

Procedure:
• transurethral 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.
• transurethral prostatic resection
The patients' prostate was resected with the conventional Nesbit TURP

Locations

Country	Name	City	State
China	Department of Urology, Southwest Hospital	Shapinba	Chongqin

Sponsors (1)

Lead Sponsor	Collaborator
Southwest Hospital, China

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	urodynamic study		before operation and the third month, 6th month after operation	Yes