Autonomic Response During Cystodistension in Patients Suspected of Having Interstitial Cystitis

Interstitial Cystitis Clinical Trial

Official title:

Autonomic Response During Cystodistension in Patients Suspected of Having Interstitial Cystitis

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT01301365
• Other study ID #: 178/10
• Status: Enrolling by invitation
• Phase: N/A
• First received: December 21, 2010
• Last updated: February 20, 2011
• Start date: November 2010
• Est. completion date: June 2011

Study information

• Verified date: November 2010
• Source: Assaf-Harofeh Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ethics Commission
• Study type: Observational

Clinical Trial Summary

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.

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

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 100
• Est. completion date: June 2011
• Est. primary completion date: April 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Cystitis
• Cystitis, Interstitial
• Interstitial Cystitis

Locations

Country	Name	City	State
Israel	Assaf-HarofehMC	Zerifin

Sponsors (1)

Lead Sponsor	Collaborator
Assaf-Harofeh Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	changes in blood pressure and pulse		measuring blood pressure and pulse at the beginning of the anasthesia and at the end of the cystodistension	No