Bladder Thermal Distention for Patients With Interstitial Cystitis / Painful Bladder Syndrome (IC)
Primary Purpose
Interstitial Cystitis, Painful Bladder Syndrome
Status
Unknown status
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Bladder Thermal Distention
Sponsored by
About this trial
This is an interventional treatment trial for Interstitial Cystitis focused on measuring Interstitial cystitis, painful bladder syndrome, bladder hydrodistention, hyperthermia
Eligibility Criteria
Inclusion Criteria:
-All patients with interstitial cystitis / painful bladder syndrome (IC/PBS) who had previous intravesical treatment with DMSO
Exclusion Criteria:
- Active infection
- Urethral stricture
Sites / Locations
- Assaf Harofe Medical CenterRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Bladder Thermal Distention (BTD)
Arm Description
Continuous irrigation of the bladder with warm saline (up to 45 Celsius) using the PelvixTT system
Outcomes
Primary Outcome Measures
o'leary sant questionnaire
o'leary sant questionnaire is a validated specific tool for evaluation of IC/PBS symptoms
Secondary Outcome Measures
Bladder diary
symptoms like urgency. frequency and functional voided volumes will be monitored
Full Information
NCT ID
NCT01838486
First Posted
April 19, 2013
Last Updated
April 23, 2013
Sponsor
Assaf-Harofeh Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT01838486
Brief Title
Bladder Thermal Distention for Patients With Interstitial Cystitis / Painful Bladder Syndrome
Acronym
IC
Official Title
Bladder Thermal Distention for Patients With Interstitial Cystitis / Painful Bladder Syndrome
Study Type
Interventional
2. Study Status
Record Verification Date
April 2013
Overall Recruitment Status
Unknown status
Study Start Date
June 2012 (undefined)
Primary Completion Date
April 2014 (Anticipated)
Study Completion Date
April 2014 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assaf-Harofeh Medical Center
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Patients with Interstitial Cystitis / PBS will be treated with bladder thermal distention (BTD).
Detailed Description
In this study we will evaluate the efficacy of bladder thermal distention (BTD) in patients with IC/PBS.
Patients with previous failed conventional treatment (intravesical DMSO) will be recruited.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Interstitial Cystitis, Painful Bladder Syndrome
Keywords
Interstitial cystitis, painful bladder syndrome, bladder hydrodistention, hyperthermia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Bladder Thermal Distention (BTD)
Arm Type
Experimental
Arm Description
Continuous irrigation of the bladder with warm saline (up to 45 Celsius) using the PelvixTT system
Intervention Type
Procedure
Intervention Name(s)
Bladder Thermal Distention
Other Intervention Name(s)
PelvixTT - Hyperthermia Elmedical LTD, Israel
Intervention Description
Bladder Thermal Distention (BTD) is an approved procedure in Europe and Israel. Continuous irrigation of the bladder with warm saline with the PelvixTT system. The procedure will be performed on an outpatients basis. The procedure lasts 1 hour.
Primary Outcome Measure Information:
Title
o'leary sant questionnaire
Description
o'leary sant questionnaire is a validated specific tool for evaluation of IC/PBS symptoms
Time Frame
up to 1 year
Secondary Outcome Measure Information:
Title
Bladder diary
Description
symptoms like urgency. frequency and functional voided volumes will be monitored
Time Frame
up to 1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
-All patients with interstitial cystitis / painful bladder syndrome (IC/PBS) who had previous intravesical treatment with DMSO
Exclusion Criteria:
Active infection
Urethral stricture
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kobi Stav, MD
Phone
972-8-9779409
Email
stavkobi@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kobi Stav, MD
Organizational Affiliation
Assaf Harofe Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Assaf Harofe Medical Center
City
Zerifin
ZIP/Postal Code
70300
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kobi Stav, MD
Email
stavkobi@gmail.com
First Name & Middle Initial & Last Name & Degree
Kobi Stav, MD
12. IPD Sharing Statement
Learn more about this trial
Bladder Thermal Distention for Patients With Interstitial Cystitis / Painful Bladder Syndrome
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