Transurethral Ventral Wall of Urethra-preserving Enucleation of Prostate

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT01073241
• Date of registration: 22/02/2010
• Primary sponsor: Southwest Hospital, China
• Public title: Transurethral Ventral Wall of Urethra-preserving Enucleation of Prostate
• Scientific title: Transurethral Ventral Wall of Urethra-preserving Enucleation of Prostate
• Date of first enrolment: March 2010
• Target sample size: 200
• Recruitment status: Active, not recruiting
• URL: http://clinicaltrials.gov/show/NCT01073241
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Countries of recruitment

China

Contacts

• Name: Zhang Jiahua
• Affiliation: Urology Institute of Southwest Hospital, Chongqin, China

Key inclusion & exclusion 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
- 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



Age minimum: 45 Years
Age maximum: 90 Years
Gender: Male

Health Condition(s) or Problem(s) studied

Benign Prostatic Hyperplasia

Intervention(s)

Procedure: transurethral prostatic resection

Procedure: transurethral ventral wall of urethra-preserving enucleation of prostate

Primary Outcome(s)

urodynamic study [Time Frame: before operation and the third month, 6th month after operation]

Secondary ID(s)

SouthwestH

Source(s) of Monetary Support

Please refer to primary and secondary sponsors