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Laparoscopic Prostatectomy for Chronic Prostatitis

Primary Purpose

Prostatitis, Chronic Prostatitis With Chronic Pelvic Pain Syndrome

Status
Unknown status
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
laparoscopic prostatectomy
Sponsored by
The Krongrad Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostatitis focused on measuring chronic, prostatitis, prostate, pain, pelvic, pelvis, inflamation

Eligibility Criteria

30 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • The Krongrad InstituteRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

one

Arm Description

laparoscopic prostatectomy

Outcomes

Primary Outcome Measures

NHI CPSI (chronic prostatitis symptom index)

Secondary Outcome Measures

Full Information

First Posted
October 17, 2008
Last Updated
April 29, 2011
Sponsor
The Krongrad Institute
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1. Study Identification

Unique Protocol Identification Number
NCT00775515
Brief Title
Laparoscopic Prostatectomy for Chronic Prostatitis
Official Title
Laparoscopic Prostatectomy for Chronic Prostatitis
Study Type
Interventional

2. Study Status

Record Verification Date
April 2011
Overall Recruitment Status
Unknown status
Study Start Date
October 2008 (undefined)
Primary Completion Date
October 2015 (Anticipated)
Study Completion Date
October 2015 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
The Krongrad Institute

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostatitis, Chronic Prostatitis With Chronic Pelvic Pain Syndrome
Keywords
chronic, prostatitis, prostate, pain, pelvic, pelvis, inflamation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
one
Arm Type
Experimental
Arm Description
laparoscopic prostatectomy
Intervention Type
Procedure
Intervention Name(s)
laparoscopic prostatectomy
Other Intervention Name(s)
laparoscopic radical prostatectomy, minimally invasive prostate surgery
Intervention Description
laparoscopic prostatectomy
Primary Outcome Measure Information:
Title
NHI CPSI (chronic prostatitis symptom index)
Time Frame
3 years

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Arnon Krongrad, MD
Phone
305-936-0474
Email
ak@laprp.com
First Name & Middle Initial & Last Name or Official Title & Degree
Ruth Krongrad, BSC
Phone
305-936-0474
Email
ruth@laprp.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Arnon Krongrad, MD
Organizational Affiliation
The Krongrad Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Krongrad Institute
City
Aventura
State/Province
Florida
ZIP/Postal Code
33180
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ruth Krongrad, BSC
Phone
305-936-0474
Email
ruth@laprp.com
First Name & Middle Initial & Last Name & Degree
Arnon Krongrad, MD

12. IPD Sharing Statement

Citations:
Citation
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
Results Reference
result
Links:
URL
http://ProstatitisSurgery.com
Description
Get More Information and Download Informed Consent

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Laparoscopic Prostatectomy for Chronic Prostatitis

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