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Laparoscopic Prostatectomy for Chronic Prostatitis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00775515
Recruitment Status : Unknown
Verified April 2011 by The Krongrad Institute.
Recruitment status was:  Recruiting
First Posted : October 20, 2008
Last Update Posted : May 2, 2011
Information provided by:
The Krongrad Institute

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.

Condition or disease Intervention/treatment Phase
Prostatitis Chronic Prostatitis With Chronic Pelvic Pain Syndrome Procedure: laparoscopic prostatectomy Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Laparoscopic Prostatectomy for Chronic Prostatitis
Study Start Date : October 2008
Estimated Primary Completion Date : October 2015
Estimated Study Completion Date : October 2015

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: one
laparoscopic prostatectomy
Procedure: laparoscopic prostatectomy
laparoscopic prostatectomy
Other Names:
  • laparoscopic radical prostatectomy
  • minimally invasive prostate surgery

Primary Outcome Measures :
  1. NHI CPSI (chronic prostatitis symptom index) [ Time Frame: 3 years ]

Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years and older   (Adult, Older Adult)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00775515

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Contact: Arnon Krongrad, MD 305-936-0474 ak@laprp.com
Contact: Ruth Krongrad, BSC 305-936-0474 ruth@laprp.com

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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         
Sponsors and Collaborators
The Krongrad Institute
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Principal Investigator: Arnon Krongrad, MD The Krongrad Institute
Additional Information:
Publications of Results:
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

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ClinicalTrials.gov Identifier: NCT00775515    
Other Study ID Numbers: 20081635
First Posted: October 20, 2008    Key Record Dates
Last Update Posted: May 2, 2011
Last Verified: April 2011
Keywords provided by The Krongrad Institute:
Additional relevant MeSH terms:
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Pelvic Pain
Chronic Disease
Neurologic Manifestations
Prostatic Diseases
Disease Attributes
Pathologic Processes