The Effect of Spermatic Vein Embolization on Prostatic Hypertrophy

Varicocele Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00639899
• Other study ID #: RVS-001-IL
• Status: Completed
• Phase: N/A
• First received: March 9, 2008
• Last updated: March 19, 2008
• Start date: September 2007
• Est. completion date: March 2008

Study information

• Verified date: March 2008
• Source: Maaynei Hayesha Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: March 2008
• Est. primary completion date: March 2008
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 45 Years to 80 Years

Eligibility

Inclusion Criteria:

• Male

• Age > 45 < 80 years

• BPH

• Bilateral varicocele.

Exclusion Criteria:

• Coagulation disturbance

• CHF

• Malignancy

• Renal failure.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hypertrophy
• Varicocele

Intervention

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

Locations

Country	Name	City	State
Israel	Maaynei Hayeshua Medical Center	Bnei Brak

Sponsors (1)

Lead Sponsor	Collaborator
Maaynei Hayesha Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety performance of the procedure. Reduction of above 20% in prostatic calculated volume.		1 year	Yes
Secondary	Reduction of above 20% in nocturia		1 year	No