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Autonomic Response During Cystodistension in Patients Suspected of Having Interstitial Cystitis

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified November 2010 by Assaf-Harofeh Medical Center.
Recruitment status was:  Enrolling by invitation
Sponsor:
ClinicalTrials.gov Identifier:
NCT01301365
First Posted: February 23, 2011
Last Update Posted: February 23, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Assaf-Harofeh Medical Center
  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:


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 ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Assaf-Harofeh Medical Center, Medical Center
ClinicalTrials.gov Identifier: NCT01301365     History of Changes
Other Study ID Numbers: 178/10
First Submitted: December 21, 2010
First Posted: February 23, 2011
Last Update Posted: February 23, 2011
Last Verified: November 2010

Keywords provided by Assaf-Harofeh Medical Center:
autonomic response

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