Laparoscopic Prostatectomy for Chronic Prostatitis

Prostatitis Clinical Trial

Official title:

Laparoscopic Prostatectomy for Chronic Prostatitis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00775515
• Other study ID #: 20081635
• Status: Recruiting
• Phase: Phase 2
• First received: October 17, 2008
• Last updated: April 29, 2011
• Start date: October 2008
• Est. completion date: October 2015

Study information

• Verified date: April 2011
• Source: The Krongrad Institute
• Contact: Arnon Krongrad, MD
• Phone: 305-936-0474
• Email: ak[@]laprp.com
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: October 2015
• Est. primary completion date: October 2015
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 30 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Disease
• Chronic Prostatitis With Chronic Pelvic Pain Syndrome
• Pelvic Pain
• Prostatitis

Intervention

Procedure:
• laparoscopic prostatectomy
laparoscopic prostatectomy

Locations

Country	Name	City	State
United States	The Krongrad Institute	Aventura	Florida

Sponsors (1)

Lead Sponsor	Collaborator
The Krongrad Institute

Country where clinical trial is conducted

United States, 

References & 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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	NHI CPSI (chronic prostatitis symptom index)		3 years	No

External Links

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