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Autonomic Response During Cystodistension in Patients Suspected of Having Interstitial Cystitis

This study is enrolling participants by invitation only.
Sponsor:
Information provided by:
Assaf-Harofeh Medical Center
ClinicalTrials.gov Identifier:
NCT01301365
First received: December 21, 2010
Last updated: February 20, 2011
Last verified: November 2010
History of Changes
  Purpose

The aim of this study is to check whether patients with cystoscopic findings supporting the diagnosis of Interstitial Cystitis (IC) have a higher autonomic response (change in blood pressure / pulse)than patients without cystoscopic findings.


Condition
Interstitial Cystitis

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Autonomic Response During Cystodistension in Patients Suspected of Having Interstitial Cystitis

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Assaf-Harofeh Medical Center:

Primary Outcome Measures:
  • changes in blood pressure and pulse [ Time Frame: measuring blood pressure and pulse at the beginning of the anasthesia and at the end of the cystodistension ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: November 2010
Estimated Study Completion Date: June 2011
Estimated Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Detailed Description:

checking the changes in blood pressure and pulse rate during the initiation of the anesthesia and at the completion of the cystodistension in patient with cystoscopic finding supporting IC

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

All patients having cystodistension suspected of painful bladder syndrome

Criteria

Inclusion Criteria:

  • All patients having cystodistension suspected of painful bladder syndrome
  • symptoms lasting for at least six months
  • symptoms suspect of the syndrome: super pubic pain, urinary urgency and frequency
  • lack of urinary infection or any other pathology of the urinary tract

Exclusion Criteria:

  • Refusal of the patient to participate
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01301365

Locations
Israel
Assaf-HarofehMC
Zerifin, Israel, 70300
Sponsors and Collaborators
Assaf-Harofeh Medical Center
Investigators
Study Director: kobi stav, MD Assaf-Harofeh Medical Center
  More Information

No publications provided

Responsible Party: Assaf-Harofeh Medical Center, Medical Center
ClinicalTrials.gov Identifier: NCT01301365     History of Changes
Other Study ID Numbers: 178/10
Study First Received: December 21, 2010
Last Updated: February 20, 2011
Health Authority: Israel: Ethics Commission

Keywords provided by Assaf-Harofeh Medical Center:
autonomic response

Additional relevant MeSH terms:
Cystitis
Cystitis, Interstitial
Urinary Bladder Diseases
Urologic Diseases

ClinicalTrials.gov processed this record on May 16, 2013