Overview

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

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, outcomes assessor)
Primary purpose treatment
Arm
(Active Comparator)
The patients' prostate was resected with the conventional Nesbit TURP.
transurethral prostatic resection TURP
The patients' prostate was resected with the conventional Nesbit TURP
(Experimental)
The patients' ventral wall of the prostate urethra was preserved and enucleation of prostate was performed for the left hyperplasia in the envelop.
transurethral ventral wall of urethra-preserving enucleation of prostate TUEP
The patients' ventral wall of the prostate urethra was preserved and enucleation of prostate was performed for the left hyperplasia in the envelop.

Primary Outcomes

Measure
urodynamic study
time frame: before operation and the third month, 6th month after operation

Eligibility Criteria

Male participants from 45 years up to 90 years old.

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

Additional Information

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.
Trial information was received from ClinicalTrials.gov and was last updated in March 2010.
Information provided to ClinicalTrials.gov by Southwest Hospital, China.