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
  Purpose

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 Intervention
Varicocele
Procedure: Sclerotherapy

Study Type: Interventional
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

Further study details as provided by Maaynei Hayesha Medical Center:

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

Secondary Outcome Measures:
  • Reduction of above 20% in nocturia [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Enrollment: 35
Study Start Date: September 2007
Study Completion Date: March 2008
Primary Completion Date: March 2008 (Final data collection date for primary outcome measure)
Intervention Details:
    Procedure: Sclerotherapy
    Super-selective retrograde venography and sclerotherapy of internal spermatic veins and associated venous bypasses and retro-peritoneal collateral
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.

  Eligibility

Ages Eligible for Study:   45 Years to 80 Years
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Dr Uriel Levinger, Maaynei Hayesha Medical Center
ClinicalTrials.gov Identifier: NCT00639899     History of Changes
Other Study ID Numbers: RVS-001-IL
Study First Received: March 9, 2008
Last Updated: March 19, 2008
Health Authority: Israel: Ministry of Health

Keywords provided by Maaynei Hayesha Medical Center:
Varicocele

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

ClinicalTrials.gov processed this record on April 23, 2014