The Effect of Spermatic Vein Embolization on Prostatic Hypertrophy
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.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|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|
- Safety performance of the procedure. Reduction of above 20% in prostatic calculated volume. [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
- Reduction of above 20% in nocturia [ Time Frame: 1 year ] [ Designated as safety issue: No ]
|Study Start Date:||September 2007|
|Study Completion Date:||March 2008|
|Primary Completion Date:||March 2008 (Final data collection date for primary outcome measure)|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00639899
|Maaynei Hayeshua Medical Center|
|Bnei Brak, Israel, 51544|
|Principal Investigator:||Uriel Levinger, MD||Maaynei Hayeshua Medical Center|