VaricoceleNCT00639899
The Effect of Spermatic Vein Embolization on Prostatic Hypertrophy
A study testing Sclerotherapy in people with Varicocele, run by Maaynei Hayesha Medical Center at 1 site in Israel.
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… Read more about this study
- Who is it for?
- Ages 45 to 80 years, men only
- Conditions the study is for
- Varicocele
- What is being tested?
- Sclerotherapy
- Type of treatment
- Surgery or procedure
- How many people
- 35 participants
- Where
- 1 siteIsrael
- Study dates
- Sep 2007to Mar 2008
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 80 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male
- Age > 45 < 80 years
- BPH
- Bilateral varicocele.
Who cannot join
- Coagulation disturbance
- CHF
- Malignancy
- Renal failure.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Varicocele
- Being tested
- Sclerotherapy
- Keywords
- Varicocele
- Medical subject headings
- Varicocele
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SclerotherapyProcedure or surgery
Super-selective retrograde venography and sclerotherapy of internal spermatic veins and associated venous bypasses and retro-peritoneal collateral
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety performance of the procedure. Reduction of above 20% in prostatic calculated volume.
Measured: 1 year
Secondary outcomes (1)
Reduction of above 20% in nocturia
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2008 (estimated)
- Study startSep 2007
- Primary completionMar 2008
- Study completionMar 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for VaricoceleStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maaynei Hayesha Medical Center
- Sponsor type
- University, hospital or other
- Investigators
- Uriel Levinger, MD, Principal investigator, Maaynei Hayeshua Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00639899
- Sponsor's protocol ID
- RVS-001-IL
- Status last verified
- Mar 2008
- First submitted
- 9 Mar 2008
- Last updated
- 20 Mar 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00639899
- Acronym / sponsor ID
- RVS-001-IL
- Conditions
- Varicocele
- Keywords
- Varicocele
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Maaynei Hayesha Medical CenterUniversity, hospital or other
- Study start
- Sep 2007
- Primary completion
- Mar 2008 (actual)
- Study completion
- Mar 2008 (actual)
- First posted
- 20 Mar 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 45 to 80 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male
- Age > 45 < 80 years
- BPH
- Bilateral varicocele.
Key exclusion criteria (4 listed)
- Coagulation disturbance
- CHF
- Malignancy
- Renal failure.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SclerotherapySuper-selective retrograde venography and sclerotherapy of internal spermatic veins and associated venous bypasses and retro-peritoneal collateral | Procedure or surgery | – |
Primary outcome
Safety performance of the procedure. Reduction of above 20% in prostatic calculated volume.
Time frame: 1 year
1 secondary outcome
Reduction of above 20% in nocturia
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2008.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Uriel Levinger, MD principal investigator
Maaynei Hayeshua Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sclerotherapy in people with Varicocele, run by Maaynei Hayesha Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Mar 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety performance of the procedure. Reduction of above 20% in prostatic calculated volume. (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2008; AzTrials last refreshed its copy on 6 Nov 2026.