Intravesical Liposomes for Ulcerative Cystitis

NCT ID: NCT01083979

Last Updated: 2017-02-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 1 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-08-31
• Study Completion Date: 2010-10-31

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.

Conditions

Interstitial Cystitis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Liposomes

Intravesical instillation of Liposomes in sterile water totally 40 cc at four weekly treatments.

Group Type: EXPERIMENTAL

Liposomes

Intervention Type: DRUG

Intravesical instillation

Interventions

Liposomes

Intravesical instillation

Intervention Type: DRUG

Other Intervention Names

Bladder instillation

Eligibility Criteria

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.

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Kenneth Peters, MD

OTHER

Sponsor Role: lead

Responsible Party

Kenneth Peters, MD

Principal Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Kenneth M Peters, MD

Role: PRINCIPAL_INVESTIGATOR

William Beaumont Hospitals

Locations

William Beaumont Hospital

Royal Oak, Michigan, United States

Countries

United States

Other Identifiers

2010-021

Identifier Type: -

Identifier Source: org_study_id