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Intravesical Liposomes for Ulcerative Cystitis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01083979
Recruitment Status : Completed
First Posted : March 10, 2010
Results First Posted : February 8, 2017
Last Update Posted : February 8, 2017
Sponsor:
Information provided by (Responsible Party):
Kenneth Peters, MD, William Beaumont Hospitals

Tracking Information
First Submitted Date  ICMJE March 8, 2010
First Posted Date  ICMJE March 10, 2010
Results First Submitted Date  ICMJE December 24, 2013
Results First Posted Date  ICMJE February 8, 2017
Last Update Posted Date February 8, 2017
Study Start Date  ICMJE August 2010
Actual Primary Completion Date October 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 14, 2016)
Change in Symptom and Problem Severity [ Time Frame: Baseline to 12 weeks ]
The primary objective is to determine the impact of 4 weekly bladder instillations of liposomes on symptoms in one patient with ulcerative interstitial cystitis (IC). The primary endpoint will be assessed at the end of the study, 8 weeks after the last bladder instillation, and will be measured by the O'Leary-Sant IC Symptom and Problem Indices (ICSI-PI) questionnaire. The ICSI is composed of 4 questions that address the occurrence of IC symptoms, specifically urinary urgency, frequency, nocturia, and bladder pain. Scores range from 0 (Not at All) to 5 (Almost Always). The IC Problem Indices questionnaire is also composed of 4 questions. Each question asks the patient to indicate how big a problem each of the 4 symptoms are to them. Scores range from 0 (No Problem) to 4 (Big Problem). Responses to all 8 questions are added together to create a total ICSI-PI score. The total ICSI-PI scores ranges from 0 to 36. A lower score indicates less IC symptoms and/or related problem
Original Primary Outcome Measures  ICMJE
 (submitted: March 9, 2010)
Change in symptom severity [ Time Frame: 4 and 8 weeks ]
The primary objective is to determine the impact of 4 weekly bladder instillations of liposomes on symptoms in one patient with ulcerative IC. The primary endpoint will be changes in symptom severity from baseline to the end of weeks 4 and 8 as measured by the O'Leary-Sant IC Symptom and Problem Indices (ICSI-PI) questionnaire.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 14, 2016)
Bladder Appearance [ Time Frame: Baseline to 12 Weeks ]
The secondary objective to assess treatment efficacy will compare the number of bladder ulcers pre-treatment to the number of ulcers visualized at 12 weeks, the end of the study.
Original Secondary Outcome Measures  ICMJE
 (submitted: March 9, 2010)
Safety and Tolerability [ Time Frame: 4 and 8 weeks ]
The secondary objective is to determine the safety and tolerability of liposomes instilled into the bladder as a compassionate use treatment in one patient with ulcerative IC. Secondary endpoints will include: Assessment of adverse events; changes in urinary frequency, urgency, and pelvic pain as recorded on voiding diaries at baseline, and at 4 and 8 weeks; cystoscopic changes in bladder inflammation/ulcers.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Intravesical Liposomes for Ulcerative Cystitis
Official Title  ICMJE Intravesical Liposomes for Ulcerative Cystitis
Brief Summary The objective is to instill liposomes reconstituted with sterile water into the bladder as a compassionate use treatment in one patient with ulcerative interstitial cystitis (IC).
Detailed Description

A physician sponsored Investigation New Drug (IN) has been acquired from the FDA for compassionate use of this non-approved treatment in one patient from Dr. Peters' private practice. Since this treatment has not been used previously in the US, we propose to evaluate the safety and efficacy of the treatment in this one patient by comparing pre and post treatment symptom changes.

Prior to treatment (visit 1) baseline measures will be assessed: vital signs,pelvic/bladder pain on a visual analog scale (VAS; "0" being none and "10" being severe), concomitant medications, Serum pregnancy test and Antiphospholipid Antibody Panel, Urine cytology, urinalysis (dipstick), and culture.

At visits 2-5 (4 treatment visits) questionnaires will be completed and vital signs, pain VAS, post void residual (measured by bladder scan or catheter), unanticipated events, and voiding history (voiding diary) will also be assessed. Additionally, cystoscopy will be done prior to the first treatment to view the bladder lining. At each treatment visit, the patients will have a solution of liposomes instilled in the bladder with a catheter, retained for 30 minutes, and be carefully monitored for at least 1 hour after the liposomes are drained.

After treatment, visits 6 and 7 (follow up) will include vital signs with VAS pain assessment, post void residual (PVR), urinalysis (dipstick), unanticipated events assessment, questionnaire completion and review of voiding diary. Visit 8 (study exit) will include the same parameters measured at follow up visits 6 and 7 with the addition of cystoscopy and Antiphospholipid Antibody Panel testing.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Interstitial Cystitis
Intervention  ICMJE Drug: Liposomes
Intravesical instillation
Other Name: Bladder instillation
Study Arms  ICMJE Experimental: Liposomes
Intravesical instillation of Liposomes in sterile water totally 40 cc at four weekly treatments.
Intervention: Drug: Liposomes
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 9, 2010)
1
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE October 2010
Actual Primary Completion Date October 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Ulcerative IC for at least 6 months documented,
  • Negative urine cytology,
  • Able to independently complete self administered questionnaires and voiding diaries.

Exclusion Criteria:

  • Pregnant or lactating,
  • History of bleeding diathesis,
  • On anticoagulant therapy,
  • Active peptic ulcer disease,
  • Obvious neurological impairment,
  • Known allergy to liposomes.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01083979
Other Study ID Numbers  ICMJE 2010-021
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Plan Description: No plan to make individual participant data available
Responsible Party Kenneth Peters, MD, William Beaumont Hospitals
Study Sponsor  ICMJE Kenneth Peters, MD
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Kenneth M Peters, MD William Beaumont Hospitals
PRS Account William Beaumont Hospitals
Verification Date December 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP