Recruiting
Phase 2

Laparoscopic Prostatectomy

Sponsor:

The Krongrad Institute

Code:

NCT00775515

Conditions

Prostatitis

Chronic Prostatitis With Chronic Pelvic Pain Syndrome

Eligibility Criteria

Sex: Male

Age: 30+

Healthy Volunteers: Not accepted

Interventions

laparoscopic prostatectomy

Study Details

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

Study ID

NCT00775515

Start date

Oct, 2008

Status verified date

Apr, 2011

Completion date

Oct, 2015

Anticipated

Primary completion date

Oct, 2015

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 30+

Healthy Volunteers: Not accepted

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

Enrollment

100 participants

Anticipated

Allocation

Non randomized

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: one

laparoscopic prostatectomy

Interventions

laparoscopic prostatectomy

laparoscopic prostatectomy

Primary outcome measure

  • NHI CPSI (chronic prostatitis symptom index) [ Time Frame: 3 years ]

Central Contacts and Locations

Central contacts

Arnon Krongrad, MD

305-936-0474ak@laprp.com

Ruth Krongrad, BSC

305-936-0474ruth@laprp.com

Locations

The Krongrad Institute

Recruiting

Aventura, Florida, United States, 33180

Contacts

Ruth Krongrad, BSC

305-936-0474ruth@laprp.com

Principal Investigator:

Arnon Krongrad, MD

More Information

Sponsor

The Krongrad Institute

Last update posted

May 2, 2011

Last verified

Apr, 2011

Keywords

  • chronic
  • prostatitis
  • prostate
  • pain
  • pelvic
  • pelvis
  • inflamation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by The Krongrad Institute on 2011-05-02.