Skip to main content
OpenTrials
Completed

NCT Number: NCT00639899

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Varicocele Cardiovascular Diseases Genital Diseases Genital Diseases, Male Male Urogenital Diseases Urogenital Diseases Vascular Diseases

Age range

45 year–80 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Maaynei Hayeshua Medical Center

Bnei Brak, 51544, Israel

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Coagulation disturbance
  • CHF
  • Malignancy
  • Renal failure.

Treatment and study plan

Sclerotherapy

Procedure

Super-selective retrograde venography and sclerotherapy of internal spermatic veins and associated venous bypasses and retro-peritoneal collateral

Primary outcomes

  1. Safety performance of the procedure. Reduction of above 20% in prostatic calculated volume.

    Time frame: 1 year

Secondary outcomes

  1. Reduction of above 20% in nocturia

    Time frame: 1 year

Sponsors and collaborators

Lead sponsor

Maaynei Hayesha Medical Center

Other

Registry information

Official study 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

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Mar 20, 2008
Registry last updated
Mar 20, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.