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The Effect of Spermatic Vein Embolization on Prostatic Hypertrophy

M

Maaynei Hayesha Medical Center

Status

Completed

Conditions

Varicocele

Treatments

Procedure: Sclerotherapy

Study type

Interventional

Funder types

Other

Identifiers

NCT00639899
RVS-001-IL

Details and patient eligibility

About

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.

Full 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.

Enrollment

35 patients

Sex

Male

Ages

45 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

  • Coagulation disturbance
  • CHF
  • Malignancy
  • Renal failure.

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Single Group Assignment

Masking

None (Open label)

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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