Laparoscopic Prostatectomy for Chronic Prostatitis
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Prostatitis Chronic Prostatitis With Chronic Pelvic Pain Syndrome |
Procedure: laparoscopic prostatectomy |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Laparoscopic Prostatectomy for Chronic Prostatitis |
- NHI CPSI (chronic prostatitis symptom index) [ Time Frame: 3 years ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 100 |
| Study Start Date: | October 2008 |
| Estimated Study Completion Date: | October 2015 |
| Estimated Primary Completion Date: | October 2015 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: one
laparoscopic prostatectomy
|
Procedure: laparoscopic prostatectomy
laparoscopic prostatectomy
Other Names:
|
Eligibility| Ages Eligible for Study: | 30 Years and older |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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
Exclusion Criteria:
- Inability to tolerate Anesthesia
- Inability to speak any English
Contacts and Locations| Contact: Arnon Krongrad, MD | 305-936-0474 | ak@laprp.com |
| Contact: Ruth Krongrad, BSC | 305-936-0474 | ruth@laprp.com |
| United States, Florida | |
| The Krongrad Institute | Recruiting |
| Aventura, Florida, United States, 33180 | |
| Contact: Ruth Krongrad, BSC 305-936-0474 ruth@laprp.com | |
| Principal Investigator: Arnon Krongrad, MD | |
| Principal Investigator: | Arnon Krongrad, MD | The Krongrad Institute |
More Information
Additional Information:
No publications provided
| Responsible Party: | ARNON KRONGRAD,M.D., THE KRONGRAD INSTITUTE |
| ClinicalTrials.gov Identifier: | NCT00775515 History of Changes |
| Other Study ID Numbers: | 20081635 |
| Study First Received: | October 17, 2008 |
| Last Updated: | April 29, 2011 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by The Krongrad Institute:
|
chronic prostatitis prostate pain |
pelvic pelvis inflamation |
Additional relevant MeSH terms:
|
Pelvic Pain Prostatitis Chronic Disease Pain Signs and Symptoms |
Prostatic Diseases Genital Diseases, Male Disease Attributes Pathologic Processes |
ClinicalTrials.gov processed this record on June 17, 2013