N/A
N=1
Intravesical Liposomes for Ulcerative Cystitis
Interstitial Cystitis
Bottom Line
View on ClinicalTrials.gov: NCT01083979 ↗Enrolled (actual)
1
Serious AEs
0.0%
Results posted
Feb 2017
Primary outcome: Primary: Change in Symptom and Problem Severity — 22; 13 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Liposomes (Drug)
- Age
- Adult, Older Adult · 20+ yrs
- Sex
- All
- Sponsor
- Kenneth Peters, MD
- Primary completion
- Oct 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Symptom and Problem Severity |
22; 13 | — |
| SECONDARY Bladder Appearance |
3; 0 | — |
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).
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.
Data sourced from ClinicalTrials.gov (NCT01083979). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.