Laparoscopic Prostatectomy for Chronic Prostatitis
| Tracking Information | |||||||||
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| First Received Date ICMJE | October 17, 2008 | ||||||||
| Last Updated Date | April 29, 2011 | ||||||||
| Start Date ICMJE | October 2008 | ||||||||
| Estimated Primary Completion Date | October 2015 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
NHI CPSI (chronic prostatitis symptom index) [ Time Frame: 3 years ] [ Designated as safety issue: No ] | ||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT00775515 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Laparoscopic Prostatectomy for Chronic Prostatitis | ||||||||
| Official Title ICMJE | Laparoscopic Prostatectomy for Chronic Prostatitis | ||||||||
| Brief 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. 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. |
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| Detailed Description | Not Provided | ||||||||
| Study Type ICMJE | Interventional | ||||||||
| Study Phase | Phase 2 | ||||||||
| Study Design ICMJE | Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
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| Condition ICMJE |
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| Intervention ICMJE | Procedure: laparoscopic prostatectomy
laparoscopic prostatectomy
Other Names:
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| Study Arm (s) | Experimental: one
laparoscopic prostatectomy
Intervention: Procedure: laparoscopic prostatectomy |
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| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 100 | ||||||||
| Estimated Completion Date | October 2015 | ||||||||
| Estimated Primary Completion Date | October 2015 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Male | ||||||||
| Ages | 30 Years and older | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | United States | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT00775515 | ||||||||
| Other Study ID Numbers ICMJE | 20081635 | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| Responsible Party | ARNON KRONGRAD,M.D., THE KRONGRAD INSTITUTE | ||||||||
| Study Sponsor ICMJE | The Krongrad Institute | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE |
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| Information Provided By | The Krongrad Institute | ||||||||
| Verification Date | April 2011 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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