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The Effect of Spermatic Vein Embolization on Prostatic Hypertrophy

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ClinicalTrials.gov Identifier: NCT00639899
Recruitment Status : Completed
First Posted : March 20, 2008
Last Update Posted : March 20, 2008
Sponsor:
Information provided by:

Study Description
Brief Summary:

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
Varicocele Procedure: Sclerotherapy

Detailed Description:

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 Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 35 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : September 2007
Primary Completion Date : March 2008
Study Completion Date : March 2008
Arms and Interventions

Intervention Details:
    Procedure: Sclerotherapy
    Super-selective retrograde venography and sclerotherapy of internal spermatic veins and associated venous bypasses and retro-peritoneal collateral

Outcome Measures

Primary Outcome Measures :
  1. Safety performance of the procedure. Reduction of above 20% in prostatic calculated volume. [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. Reduction of above 20% in nocturia [ Time Frame: 1 year ]

Eligibility Criteria

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Ages Eligible for Study:   45 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Coagulation disturbance
  • CHF
  • Malignancy
  • Renal failure.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00639899


Locations
Israel
Maaynei Hayeshua Medical Center
Bnei Brak, Israel, 51544
Sponsors and Collaborators
Maaynei Hayesha Medical Center
Investigators
Principal Investigator: Uriel Levinger, MD Maaynei Hayeshua Medical Center
More Information

Responsible Party: Dr Uriel Levinger, Maaynei Hayesha Medical Center
ClinicalTrials.gov Identifier: NCT00639899     History of Changes
Other Study ID Numbers: RVS-001-IL
First Posted: March 20, 2008    Key Record Dates
Last Update Posted: March 20, 2008
Last Verified: March 2008

Keywords provided by Maaynei Hayesha Medical Center:
Varicocele

Additional relevant MeSH terms:
Hypertrophy
Varicocele
Pathological Conditions, Anatomical
Genital Diseases, Male
Vascular Diseases
Cardiovascular Diseases