Laparoscopic Prostatectomy for Chronic Prostatitis

NCT00775515 | Unknown Phase 2

• 1 other identifier: 20081635
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostatitis; Chronic Prostatitis With Chronic Pelvic Pain Syndrome

Keywords

chronic; prostatitis; prostate; pain; pelvic; pelvis; inflamation

Outcome Measures

Primary Outcomes (1)

• NHI CPSI (chronic prostatitis symptom index)

  3 years

Study Arms (1)

one

EXPERIMENTAL

laparoscopic prostatectomy

Procedure: laparoscopic prostatectomy

Interventions

laparoscopic prostatectomy PROCEDURE

laparoscopic prostatectomy

Also known as: laparoscopic radical prostatectomy, minimally invasive prostate surgery

one

Eligibility Criteria

• Age: 30 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Inability to tolerate Anesthesia
• Inability to speak any English

Sponsors & Collaborators

• The Krongrad Institute: lead

Study Sites (1)

The Krongrad Institute

Aventura, Florida, 33180, United States

RECRUITING

Related Publications (1)

• 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

  RESULT

Related Links

• Get More Information and Download Informed Consent

MeSH Terms

Conditions

Prostatitis; Bronchiolitis Obliterans Syndrome; Pain

Condition Hierarchy (Ancestors)

Prostatic Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases; Organizing Pneumonia; Bronchiolitis Obliterans; Bronchiolitis; Bronchitis; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Graft vs Host Disease; Immune System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Arnon Krongrad, MD

  The Krongrad Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Arnon Krongrad, MD

CONTACT

305-936-0474; ak@laprp.com

Ruth Krongrad, BSC

CONTACT

305-936-0474; ruth@laprp.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: October 17, 2008
• First Posted: October 20, 2008
• Study Start: October 1, 2008
• Primary Completion: October 1, 2015
• Study Completion: October 1, 2015
• Last Updated: May 2, 2011

Record last verified: 2011-04

Locations

US (1)