Interstitial CystitisNCT01301365
Autonomic Response During Cystodistension in Patients Suspected of Having Interstitial Cystitis
An observational study of Interstitial Cystitis, run by Assaf-Harofeh Medical Center at 1 site in Israel.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Interstitial Cystitis
- How many people
- 100 participants
- Where
- 1 siteIsrael
- Study dates
- Nov 2010to Jun 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients having cystodistension suspected of painful bladder syndrome
Who may be able to join
- 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
Who cannot join
- Refusal of the patient to participate
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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
- Conditions
- Interstitial Cystitis
- Keywords
- autonomic response
- Medical subject headings
- Cystitis, Interstitial
What is being measured
The primary outcome is the main question the study is designed to answer.
changes in blood pressure and pulse
Measured: measuring blood pressure and pulse at the beginning of the anasthesia and at the end of the cystodistension
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2011 (estimated)
- Study startNov 2010
- Primary completionApr 2011 (estimated)
- Study completionJun 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Interstitial CystitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assaf-Harofeh Medical Center
- Sponsor type
- Other government
- Investigators
- kobi stav, MD, Study director, Assaf-Harofeh Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01301365
- Sponsor's protocol ID
- 178/10
- Status last verified
- Nov 2010
- First submitted
- 21 Dec 2010
- Last updated
- 23 Feb 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Autonomic Response During Cystodistension in Patients Suspected of Having Interstitial Cystitis
- ClinicalTrials.gov ID
- NCT01301365
- Acronym / sponsor ID
- 178/10
- Conditions
- Interstitial Cystitis
- Keywords
- autonomic response
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Assaf-Harofeh Medical CenterOther government
- Study start
- Nov 2010
- Primary completion
- Apr 2011 (estimated)
- Study completion
- Jun 2011 (estimated)
- First posted
- 23 Feb 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients having cystodistension suspected of painful bladder syndrome
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- Refusal of the patient to participate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2011.
Related trials for Interstitial Cystitis
Active, not recruiting
Medtronic Hugo™ Robotic Assisted Surgery (RAS) System in Urologic Surgery (Expand URO)
Bladder Cancer, Prostate Cancer
Enrolling by invitationObservational study
Migraine Medication Effects on Urinary Symptoms
Overactive Bladder, Bladder Pain Syndrome
Recruiting
EPPIC: Easing Pelvic Pain Interventions Clinical Research Program
Urologic Chronic Pelvic Pain Syndrome (UCPPS), Interstitial Cystitis
Recruiting
Investigation of PEMF Therapy for Female Patients With IC/BPS
Interstitial Cystitis, Chronic Interstitial Cystitis
Recruiting
Aerobic Exercise and Connective Tissue Massage in Painful Bladder Syndrome
Bladder Pain Syndrome, Painful Bladder Syndrome
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
kobi stav, MD study director
Assaf-Harofeh Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Interstitial Cystitis, run by Assaf-Harofeh Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Feb 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2011.