The Effect of Spermatic Vein Embolization on Prostatic Hypertrophy
Primary Purpose
Varicocele
Status
Completed
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Sclerotherapy
Sponsored by
About this trial
This is an interventional treatment trial for Varicocele focused on measuring Varicocele
Eligibility Criteria
Inclusion Criteria:
- Male
- Age > 45 < 80 years
- BPH
- Bilateral varicocele.
Exclusion Criteria:
- Coagulation disturbance
- CHF
- Malignancy
- Renal failure.
Sites / Locations
- Maaynei Hayeshua Medical Center
Outcomes
Primary Outcome Measures
Safety performance of the procedure. Reduction of above 20% in prostatic calculated volume.
Secondary Outcome Measures
Reduction of above 20% in nocturia
Full Information
NCT ID
NCT00639899
First Posted
March 9, 2008
Last Updated
March 19, 2008
Sponsor
Maaynei Hayesha Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT00639899
Brief Title
The Effect of Spermatic Vein Embolization on Prostatic Hypertrophy
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
Study Type
Interventional
2. Study Status
Record Verification Date
March 2008
Overall Recruitment Status
Completed
Study Start Date
September 2007 (undefined)
Primary Completion Date
March 2008 (Actual)
Study Completion Date
March 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Maaynei Hayesha Medical Center
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Varicocele
Keywords
Varicocele
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
35 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Procedure
Intervention Name(s)
Sclerotherapy
Intervention Description
Super-selective retrograde venography and sclerotherapy of internal spermatic veins and associated venous bypasses and retro-peritoneal collateral
Primary Outcome Measure Information:
Title
Safety performance of the procedure. Reduction of above 20% in prostatic calculated volume.
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Reduction of above 20% in nocturia
Time Frame
1 year
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Male
Age > 45 < 80 years
BPH
Bilateral varicocele.
Exclusion Criteria:
Coagulation disturbance
CHF
Malignancy
Renal failure.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Uriel Levinger, MD
Organizational Affiliation
Maaynei Hayeshua Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Maaynei Hayeshua Medical Center
City
Bnei Brak
ZIP/Postal Code
51544
Country
Israel
12. IPD Sharing Statement
Learn more about this trial
The Effect of Spermatic Vein Embolization on Prostatic Hypertrophy
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