search
Back to results

Trial Comparing Intravesical Cocktail With Intravesical Dimethyl Sulfoxide (DMSO) in Painful Bladder Syndrome/Interstitial Cystitis (PBS/IC)

Primary Purpose

Interstitial Cystitis, Bladder Diseases

Status
Terminated
Phase
Phase 2
Locations
Canada
Study Type
Interventional
Intervention
dimethyl sulfoxide
IC Cocktail
Sponsored by
Nova Scotia Health Authority
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Interstitial Cystitis focused on measuring PBS/IC, Painful bladder syndrome including Interstitial cystitis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Participants should be of age eighteen years or older Participant has painful bladder syndrome and a score of 8 or greater on the painful bladder syndrome symptom index (O'Leary-Sant) Participant should have frequency and urgency of micturition and bladder pain for at least 6 months Participant should have voids at least 8 times during a 24 hour period and at least once during the night as documented in the voiding diary and questionnaire. Urine culture should not show any evidence of urinary tract infection. Participant should be able to understand, speak, and read English. Participant should be willing to take part in the study, including signing this form after carefully reading it. Participant consents to use a medically acceptable method of birth control throughout the entire study period and for four weeks after the study is completed. Medically acceptable methods of contraception that may be used by the study participants and/or their partners include abstinence, birth control pills or patches, diaphragm with spermicide, intrauterine device (IUD), condom and vaginal spermicide, surgical sterilization, vasectomy, or progestin implants or injections. Failure of other treatments for PBS/IC like pentosan polysulfate (failure is defined as a score of +1 [slightly improved] or less on a global assessment response [GRA] 23 question to previous therapy) Exclusion Criteria: Participants who have undergone cystoscopy within 4 weeks of screening visit Participants had other treatment given into the bladder in the past 4 weeks Participants have used a new drug in the past 4 weeks which could affect bladder symptoms (some antidepressants, anticholinergics, antihistamines) Past history of treatment with cyclophosphamide A positive pregnancy test at the time of screening Currently breast feeding History of uterine, cervical, or vaginal cancer during the past 3 years History of significant vaginitis History of major surgery in the last 6 months Positive tests for HIV, hepatitis B virus (HBV), and hepatitis C virus (HCV) History of immune deficiency diseases History of bleeding disorders History of serious social, mental, or medical conditions that would stop patient from taking part in the study History of alcohol or drug abuse within the last 5 years Participants who have history of prostate cancer or are being treated for chronic bacterial prostatitis History of liver disease or significant medical problem which the investigator considers a risk for patient to be a part of the study History of any of the following: neurogenic bladder radiation to pelvic area, inflammation of the bladder wall because of tuberculosis, schistosomiasis, bladder or ureteric calculi, or active genital herpes within 3 months of screening Known hypersensitivity to one of the agents used in the intravesical instillation Use of any investigational drug or device in the last 6 months Participants who are unwilling or unable to abide by the requirements of the study

Sites / Locations

  • Dept. of Urology, Queen Elizabeth II Health Sciences Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

DMSO

Cocktail

Arm Description

Intravesical installation

Outcomes

Primary Outcome Measures

reduction of frequency of micturition

Secondary Outcome Measures

reduction in pain
overall improvement of symptoms

Full Information

First Posted
April 20, 2006
Last Updated
May 8, 2009
Sponsor
Nova Scotia Health Authority
search

1. Study Identification

Unique Protocol Identification Number
NCT00317070
Brief Title
Trial Comparing Intravesical Cocktail With Intravesical Dimethyl Sulfoxide (DMSO) in Painful Bladder Syndrome/Interstitial Cystitis (PBS/IC)
Official Title
A Randomized Controlled Trial to Evaluate the Efficacy and Tolerability of Intravesical Cocktail and Comparison With Intravesical Dimethyl Sulfoxide (DMSO) for the Treatment of Painful Bladder Syndrome Including Interstitial Cystitis (PBS/IC)
Study Type
Interventional

2. Study Status

Record Verification Date
May 2008
Overall Recruitment Status
Terminated
Why Stopped
Poor recruitment, poor patient compliance, lack of funding
Study Start Date
April 2006 (undefined)
Primary Completion Date
February 2009 (Actual)
Study Completion Date
February 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Nova Scotia Health Authority

4. Oversight

5. Study Description

Brief Summary
The primary objective of this study is to evaluate the efficacy and tolerability of the intravesical cocktail and its comparison with intravesical DMSO in a controlled trial for the treatment of painful bladder syndrome including interstitial cystitis.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Interstitial Cystitis, Bladder Diseases
Keywords
PBS/IC, Painful bladder syndrome including Interstitial cystitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
DMSO
Arm Type
Active Comparator
Arm Description
Intravesical installation
Arm Title
Cocktail
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
dimethyl sulfoxide
Intervention Description
intravesical installation 50 ml
Intervention Type
Drug
Intervention Name(s)
IC Cocktail
Intervention Description
Heparin 10,000 units Gentamicin 80 mg Hydrocortisone sodium succinate (Solucortef) 100 mg Lidocaine hydrochloride 1% 10 ml Sodium Bicarbonate 8.4% 5 ml
Primary Outcome Measure Information:
Title
reduction of frequency of micturition
Time Frame
16 weeks
Secondary Outcome Measure Information:
Title
reduction in pain
Time Frame
16 weeks
Title
overall improvement of symptoms
Time Frame
16 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Participants should be of age eighteen years or older Participant has painful bladder syndrome and a score of 8 or greater on the painful bladder syndrome symptom index (O'Leary-Sant) Participant should have frequency and urgency of micturition and bladder pain for at least 6 months Participant should have voids at least 8 times during a 24 hour period and at least once during the night as documented in the voiding diary and questionnaire. Urine culture should not show any evidence of urinary tract infection. Participant should be able to understand, speak, and read English. Participant should be willing to take part in the study, including signing this form after carefully reading it. Participant consents to use a medically acceptable method of birth control throughout the entire study period and for four weeks after the study is completed. Medically acceptable methods of contraception that may be used by the study participants and/or their partners include abstinence, birth control pills or patches, diaphragm with spermicide, intrauterine device (IUD), condom and vaginal spermicide, surgical sterilization, vasectomy, or progestin implants or injections. Failure of other treatments for PBS/IC like pentosan polysulfate (failure is defined as a score of +1 [slightly improved] or less on a global assessment response [GRA] 23 question to previous therapy) Exclusion Criteria: Participants who have undergone cystoscopy within 4 weeks of screening visit Participants had other treatment given into the bladder in the past 4 weeks Participants have used a new drug in the past 4 weeks which could affect bladder symptoms (some antidepressants, anticholinergics, antihistamines) Past history of treatment with cyclophosphamide A positive pregnancy test at the time of screening Currently breast feeding History of uterine, cervical, or vaginal cancer during the past 3 years History of significant vaginitis History of major surgery in the last 6 months Positive tests for HIV, hepatitis B virus (HBV), and hepatitis C virus (HCV) History of immune deficiency diseases History of bleeding disorders History of serious social, mental, or medical conditions that would stop patient from taking part in the study History of alcohol or drug abuse within the last 5 years Participants who have history of prostate cancer or are being treated for chronic bacterial prostatitis History of liver disease or significant medical problem which the investigator considers a risk for patient to be a part of the study History of any of the following: neurogenic bladder radiation to pelvic area, inflammation of the bladder wall because of tuberculosis, schistosomiasis, bladder or ureteric calculi, or active genital herpes within 3 months of screening Known hypersensitivity to one of the agents used in the intravesical instillation Use of any investigational drug or device in the last 6 months Participants who are unwilling or unable to abide by the requirements of the study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jerzy Gajewski, MD, FRCSC
Organizational Affiliation
Nova Scotia Health Authority
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dept. of Urology, Queen Elizabeth II Health Sciences Center
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3H 3A7
Country
Canada

12. IPD Sharing Statement

Learn more about this trial

Trial Comparing Intravesical Cocktail With Intravesical Dimethyl Sulfoxide (DMSO) in Painful Bladder Syndrome/Interstitial Cystitis (PBS/IC)

We'll reach out to this number within 24 hrs