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The Effect of Spermatic Vein Embolization on Prostatic Hypertrophy

NCT ID: NCT00639899

Last Updated: 2008-03-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

35 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-09-30

Study Completion Date

2008-03-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Varicocele

Keywords

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Varicocele

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Sclerotherapy

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

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Male
* Age \> 45 \< 80 years
* BPH
* Bilateral varicocele.

Exclusion Criteria

* Coagulation disturbance
* CHF
* Malignancy
* Renal failure.
Minimum Eligible Age

45 Years

Maximum Eligible Age

80 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Maaynei Hayesha Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Maaynei Hayesha Medical Center

Principal Investigators

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Uriel Levinger, MD

Role: PRINCIPAL_INVESTIGATOR

Maaynei Hayeshua Medical Center

Locations

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Maaynei Hayeshua Medical Center

Bnei Brak, , Israel

Site Status

Countries

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Israel

Other Identifiers

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RVS-001-IL

Identifier Type: -

Identifier Source: org_study_id