NCT01301365

Brief 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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2010

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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, 2010

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

December 21, 2010

Completed
2 months until next milestone

First Posted

Study publicly available on registry

February 23, 2011

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2011

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2011

Completed
Last Updated

February 23, 2011

Status Verified

November 1, 2010

Enrollment Period

5 months

First QC Date

December 21, 2010

Last Update Submit

February 20, 2011

Conditions

Keywords

autonomic response

Outcome Measures

Primary Outcomes (1)

  • changes in blood pressure and pulse

    measuring blood pressure and pulse at the beginning of the anasthesia and at the end of the cystodistension

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All patients having cystodistension suspected of painful bladder syndrome

You may qualify if:

  • 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

You may not qualify if:

  • Refusal of the patient to participate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assaf-HarofehMC

Ẕerifin, 70300, Israel

Location

MeSH Terms

Conditions

Cystitis, Interstitial

Condition Hierarchy (Ancestors)

CystitisUrinary Bladder DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Study Officials

  • kobi stav, MD

    Assaf-Harofeh Medical Center

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

December 21, 2010

First Posted

February 23, 2011

Study Start

November 1, 2010

Primary Completion

April 1, 2011

Study Completion

June 1, 2011

Last Updated

February 23, 2011

Record last verified: 2010-11

Locations