NCT00194636

Brief Summary

The purpose of this study is to investigate, by means of a temporary sympathetic nerve block, the involvement of the sympathetic nervous system in Chronic Pelvic Pain Syndrome (CPPS). This study may also result in a new therapeutic approach for male CPPS.

Trial Health

33
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Trial recruitment is currently suspended
Enrollment
20

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Nov 2003

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
suspended

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2003

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 19, 2005

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2006

Completed
Last Updated

April 7, 2017

Status Verified

October 1, 2007

First QC Date

September 13, 2005

Last Update Submit

April 5, 2017

Conditions

Chronic Male Pelvic Pain SyndromeProstatitis

Keywords

ProstatitisChronic Male Pelvic Pain Syndrome

Outcome Measures

Primary Outcomes (1)

  • change in symptom score; reflected in NIH-Symptom Index (CPSI) at Block Assessment Visit

Secondary Outcomes (1)

  • AUA score at Block Assessment Visit

Interventions

nerve blockPROCEDURE

Eligibility Criteria

Age18 Years - 65 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Men with Chronic Pelvic Pain Syndrome who, for the past year, have not responded to standard pain treatment modalities.

You may not qualify if:

  • Urinary tract infection with common pathogens
  • Treatment for prostate, bladder, renal, or other urinary malignancies.
  • Back pain or rectal pain only
  • Psychotic or suicidal men
  • Post-surgical pain
  • Pain from another source in genital the tract such as kidney stones or neoplasm
  • Having had radiation therapy
  • History of genitourinary tuberculosis
  • Neurological abnormalities such as stroke, brain tumors, spinal tumors, spinal cord injury and Parkinson's or Alzheimer's disease.
  • Drug allergies
  • Use of any drugs, such as antihypertensives, that would interfere with biochemical and electrodiagnostic tests.
  • Bleeding and clotting disorders such as factor deficiencies or anticoagulant drug use.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Washington - Urology Clinic

Seattle, Washington, 98195, United States

Location

MeSH Terms

Conditions

Prostatitis

Interventions

Nerve Block

Condition Hierarchy (Ancestors)

Prostatic DiseasesGenital Diseases, MaleGenital DiseasesUrogenital DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

Anesthesia, ConductionAnesthesiaAnesthesia and AnalgesiaDenervationNeurosurgical ProceduresSurgical Procedures, Operative

Study Officials

  • Richard E Berger, MD

    Professor of Urology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 19, 2005

Study Start

November 1, 2003

Study Completion

November 1, 2006

Last Updated

April 7, 2017

Record last verified: 2007-10

Locations

US(1)