Laparoscopic Prostatectomy for Chronic Prostatitis

NCT ID: NCT00775515

Last Updated: 2011-05-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-10-31

Study Completion Date

2015-10-31

Brief Summary

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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.

Detailed Description

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Conditions

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Prostatitis Chronic Prostatitis With Chronic Pelvic Pain Syndrome

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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one

laparoscopic prostatectomy

Group Type EXPERIMENTAL

laparoscopic prostatectomy

Intervention Type PROCEDURE

laparoscopic prostatectomy

Interventions

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laparoscopic prostatectomy

laparoscopic prostatectomy

Intervention Type PROCEDURE

Other Intervention Names

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laparoscopic radical prostatectomy minimally invasive prostate surgery

Eligibility Criteria

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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
Minimum Eligible Age

30 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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The Krongrad Institute

OTHER

Sponsor Role lead

Responsible Party

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THE KRONGRAD INSTITUTE

Principal Investigators

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Arnon Krongrad, MD

Role: PRINCIPAL_INVESTIGATOR

The Krongrad Institute

Locations

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The Krongrad Institute

Aventura, Florida, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Arnon Krongrad, MD

Role: CONTACT

305-936-0474

Ruth Krongrad, BSC

Role: CONTACT

305-936-0474

Facility Contacts

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Ruth Krongrad, BSC

Role: primary

305-936-0474

References

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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

Reference Type RESULT

Related Links

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http://ProstatitisSurgery.com

Get More Information and Download Informed Consent

Other Identifiers

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20081635

Identifier Type: -

Identifier Source: org_study_id

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