ProstatitisPhase 2NCT00775515
Laparoscopic Prostatectomy for Chronic Prostatitis
A Phase 2 study testing laparoscopic prostatectomy in people with Prostatitis and Chronic Prostatitis With Chronic Pelvic Pain Syndrome, run by The Krongrad Institute at 1 site in United States.
Trial summary
Prostatitis is an inflammation of the prostate, an pelvic organ of men. Prostatitis can cause great discomfort which varies but can include pelvic pain, pelvic pressure, a vague sense of discomfort, a feeling of malaise and fatigue, fever, burning on urination, pain on reaching orgasm, and bleeding. Read more about this study
- Who is it for?
- Ages 30 years and older, men only
- Conditions the study is for
- Prostatitis, Chronic Prostatitis With Chronic Pelvic Pain Syndrome
- What is being tested?
- laparoscopic prostatectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2008to Oct 2015
- Phase
- Phase 2
- 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 30 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 30 and greater
- NIH-CPSI score of 25 and higher
- Symptom duration of at least one year
- Failed treatment with antibiotics and/or other medications
Who cannot join
- Inability to tolerate Anesthesia
- Inability to speak any English
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
The Krongrad Institute
Aventura, Florida, 33180
Ruth Krongrad, BSC, 305-936-0474, ruth@laprp.com
Arnon Krongrad, MD
About this study
Prostatitis is an inflammation of the prostate, an pelvic organ of men. Prostatitis can cause great discomfort which varies but can include pelvic pain, pelvic pressure, a vague sense of discomfort, a feeling of malaise and fatigue, fever, burning on urination, pain on reaching orgasm, and bleeding.
In many men the symptoms of prostatitis can be chronic. It is estimated that in the United States chronic prostatitis is responsible for as many as two million doctor visits a year. The disease can be ruinous, interfering with work, intimacy, and other things.
The causes of chronic prostatitis are not understood. The treatments commonly used, including antibiotics and prostate massage, work poorly. We now have evidence that laparoscopic prostatectomy can eliminate the misery of chronic prostatitis. This trial aims to quantify and better characterize the effect of laparoscopic prostatectomy on the symptoms of chronic prostatitis.
- Being tested
- laparoscopic prostatectomy
- Keywords
- chronic, prostatitis, prostate, pain, pelvic, pelvis, inflamation
- Medical subject headings
- Prostatitis, Bronchiolitis Obliterans Syndrome, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
laparoscopic prostatectomyProcedure or surgery
Also called laparoscopic radical prostatectomy, minimally invasive prostate surgery
laparoscopic prostatectomy
| Study group | Role | What they receive |
|---|---|---|
| one | Experimental | laparoscopic prostatectomy Receives: Procedure: laparoscopic prostatectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
NHI CPSI (chronic prostatitis symptom index)
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2008 (estimated)
- Study startOct 2008
- Primary completionOct 2015 (estimated)
- Study completionOct 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ProstatitisStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Krongrad Institute
- Sponsor type
- University, hospital or other
- Investigators
- Arnon Krongrad, MD, Principal investigator, The Krongrad Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00775515
- Sponsor's protocol ID
- 20081635
- Status last verified
- Apr 2011
- First submitted
- 17 Oct 2008
- Last updated
- 2 May 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Krongrad A, Lai S: Laparoscopic Prostatectomy for Severely Symptomatic, Treatment-Refractory Chronic Prostatitis: Preliminary Observations from an Ongoing Phase II Clinical Trial. UroToday Int J. 2011 Apr;4(2) http://bit.ly/iLkwht
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Laparoscopic Prostatectomy for Chronic Prostatitis
- ClinicalTrials.gov ID
- NCT00775515
- Acronym / sponsor ID
- 20081635
- Keywords
- chronic, prostatitis, prostate, pain, pelvic, pelvis, inflamation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- The Krongrad InstituteUniversity, hospital or other
- Study start
- Oct 2008
- Primary completion
- Oct 2015 (estimated)
- Study completion
- Oct 2015 (estimated)
- First posted
- 20 Oct 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.
Prostatitis is an inflammation of the prostate, an pelvic organ of men. Prostatitis can cause great discomfort which varies but can include pelvic pain, pelvic pressure, a vague sense of discomfort, a feeling of malaise and fatigue, fever, burning on urination, pain on reaching orgasm, and bleeding.
In many men the symptoms of prostatitis can be chronic. It is estimated that in the United States chronic prostatitis is responsible for as many as two million doctor visits a year. The disease can be ruinous, interfering with work, intimacy, and other things.
The causes of chronic prostatitis are not understood. The treatments commonly used, including antibiotics and prostate massage, work poorly. We now have evidence that laparoscopic prostatectomy can eliminate the misery of chronic prostatitis. This trial aims to quantify and better characterize the effect of laparoscopic prostatectomy on the symptoms of chronic prostatitis.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| one | Experimental | Procedure: laparoscopic prostatectomylaparoscopic prostatectomy |
Who may qualify
- Ages
- 30 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 30 and greater
- NIH-CPSI score of 25 and higher
- Symptom duration of at least one year
- Failed treatment with antibiotics and/or other medications
Key exclusion criteria (2 listed)
- Inability to tolerate Anesthesia
- Inability to speak any English
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 |
|---|---|---|
| laparoscopic prostatectomyAlso: laparoscopic radical prostatectomy, minimally invasive prostate surgerylaparoscopic prostatectomy | Procedure or surgery | one |
Primary outcome
NHI CPSI (chronic prostatitis symptom index)
Time frame: 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2011.
- Results publicationKrongrad A, Lai S: Laparoscopic Prostatectomy for Severely Symptomatic, Treatment-Refractory Chronic Prostatitis: Preliminary Observations from an Ongoing Phase II Clinical Trial. UroToday Int J. 2011 Apr;4(2) http://bit.ly/iLkwht
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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.
Arnon Krongrad, MD principal investigator
The Krongrad Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing laparoscopic prostatectomy in people with Prostatitis and Chronic Prostatitis With Chronic Pelvic Pain Syndrome, run by The Krongrad Institute at 1 site in United States.
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 2 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: status not confirmed, as of the sponsor's last update on 2 May 2011. 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 United States. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Arnon Krongrad, MD (305-936-0474, ak@laprp.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
NHI CPSI (chronic prostatitis symptom index) (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00775515, which also lists 1 linked publication.
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 2 May 2011.