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The Effect of Spermatic Vein Embolization on Prostatic Hypertrophy

This study has been completed.
Sponsor:
Information provided by:
Maaynei Hayesha Medical Center
ClinicalTrials.gov Identifier:
NCT00639899
First received: March 9, 2008
Last updated: March 19, 2008
Last verified: March 2008

March 9, 2008
March 19, 2008
September 2007
March 2008   (final data collection date for primary outcome measure)
Safety performance of the procedure. Reduction of above 20% in prostatic calculated volume. [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00639899 on ClinicalTrials.gov Archive Site
Reduction of above 20% in nocturia [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
The Effect of Spermatic Vein Embolization on Prostatic Hypertrophy
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

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.

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.

Interventional
Not Provided
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Varicocele
Procedure: Sclerotherapy
Super-selective retrograde venography and sclerotherapy of internal spermatic veins and associated venous bypasses and retro-peritoneal collateral
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
35
March 2008
March 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Male
  • Age > 45 < 80 years
  • BPH
  • Bilateral varicocele.

Exclusion Criteria:

  • Coagulation disturbance
  • CHF
  • Malignancy
  • Renal failure.
Male
45 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
Israel
 
NCT00639899
RVS-001-IL
No
Dr Uriel Levinger, Maaynei Hayesha Medical Center
Maaynei Hayesha Medical Center
Not Provided
Principal Investigator: Uriel Levinger, MD Maaynei Hayeshua Medical Center
Maaynei Hayesha Medical Center
March 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP