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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT00775515
Other study ID # 20081635
Secondary ID
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


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
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