Laparoscopic Prostatectomy for Chronic Prostatitis

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2011 by The Krongrad Institute
Sponsor:
Information provided by:
The Krongrad Institute
ClinicalTrials.gov Identifier:
NCT00775515
First received: October 17, 2008
Last updated: April 29, 2011
Last verified: April 2011
  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

Resource links provided by NLM:


Further study details as provided by The Krongrad Institute:

Primary Outcome Measures:
  • 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:
  • laparoscopic radical prostatectomy
  • minimally invasive prostate surgery

  Eligibility

Ages Eligible for Study:   30 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00775515

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

Locations
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
Investigators
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 September 18, 2014