NCT00639899

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
35

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2007

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2007

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2008

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

March 9, 2008

Completed
11 days until next milestone

First Posted

Study publicly available on registry

March 20, 2008

Completed
Last Updated

March 20, 2008

Status Verified

March 1, 2008

Enrollment Period

6 months

First QC Date

March 9, 2008

Last Update Submit

March 19, 2008

Conditions

Varicocele

Keywords

Varicocele

Outcome Measures

Primary Outcomes (1)

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

    1 year

Secondary Outcomes (1)

  • Reduction of above 20% in nocturia

    1 year

Interventions

SclerotherapyPROCEDURE

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

Eligibility Criteria

Age45 Years - 80 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Coagulation disturbance
  • CHF
  • Malignancy
  • Renal failure.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Maaynei Hayeshua Medical Center

Bnei Brak, 51544, Israel

Location

MeSH Terms

Conditions

Varicocele

Interventions

Sclerotherapy

Condition Hierarchy (Ancestors)

Genital Diseases, MaleGenital DiseasesUrogenital DiseasesMale Urogenital DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Drug TherapyTherapeutics

Study Officials

  • Uriel Levinger, MD

    Maaynei Hayeshua Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 9, 2008

First Posted

March 20, 2008

Study Start

September 1, 2007

Primary Completion

March 1, 2008

Study Completion

March 1, 2008

Last Updated

March 20, 2008

Record last verified: 2008-03

Locations

IL(1)