The Effect of Spermatic Vein Embolization on Prostatic Hypertrophy
|ClinicalTrials.gov Identifier: NCT00639899|
Recruitment Status : Completed
First Posted : March 20, 2008
Last Update Posted : March 20, 2008
In varicocele the venous pressure in the prostatic bed is increased .This may result in raised hydrostatic pressure which in turn may stimulate prostatic hypertrophy.
Restoring normal venous drainage is expected to lower hydrostatic pressure followed by inhibition of prostatic growth and possibly leading regression in prostatic dimensions.
|Condition or disease||Intervention/treatment||Phase|
|Varicocele||Procedure: Sclerotherapy||Not Applicable|
35 male patients, aged 45 years or older, with documented benign prostatic hypertrophy (BPH)and varicocele as visualized by ultrasound and/or termography examination will be enrolled.
Each patient will undergo a full urologic examination to exclude possible malignancy as well as a thorough medical examination to establish eligibility for treatment.
In all selected patients the varicocele will be obliterated by means of embolization of the spermatic veins.
The patients will be followed every three months by abdominal ultrasound as well as by serial PSA for a period of 6-12 months.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||35 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Selective Retrograde Venography and Sclerotherapy of Internal Spermatic Veins and Associated Venous Bypasses and Retro-Peritoneal Collateral in Patients With Varicocele and Hypertrophy of Prostate|
|Study Start Date :||September 2007|
|Actual Primary Completion Date :||March 2008|
|Actual Study Completion Date :||March 2008|
- Safety performance of the procedure. Reduction of above 20% in prostatic calculated volume. [ Time Frame: 1 year ]
- Reduction of above 20% in nocturia [ Time Frame: 1 year ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00639899
|Maaynei Hayeshua Medical Center|
|Bnei Brak, Israel, 51544|
|Principal Investigator:||Uriel Levinger, MD||Maaynei Hayeshua Medical Center|