N/A
N=16
Intravesical Liposomes for Interstitial Cystitis/Painful Bladder Syndrome (IC/PBS)
Interstitial Cystitis · Pelvic Pain
Bottom Line
View on ClinicalTrials.gov: NCT01731470 ↗Enrolled (actual)
16
Serious AEs
0.0%
Results posted
Jan 2017
Primary outcome: Primary: Change in Symptom Severity at 4 and 8 Weeks Post-Treatment as Measured by the Total O'Leary-Sant IC Symptom and Problem Index (ICSI/ICPI) Score — -4; -4 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Liposomes (Biological)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Kenneth Peters, MD
- Primary completion
- Aug 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Symptom Severity at 4 and 8 Weeks Post-Treatment as Measured by the Total O'Leary-Sant IC Symptom and Problem Index (ICSI/ICPI) Score |
-4; -4 | — |
| SECONDARY Change in Pain Scores at 4 and 8 Weeks Post-Treatment as Measured by the Visual Analog Scale (VAS) |
-2; -1.14 | — |
Summary
Interstitial cystitis/painful bladder syndrome (IC/PBS) is a poorly understood chronic disorder of unknown etiology consisting of irritative bladder symptoms and pelvic pain that dramatically affects quality of life.
Preclinical study data (obtained by using an IC/PBS model in Sprague-Dawley female rats) have demonstrated normalization of urinary frequency indicating that LP may be a potent protectant of the bladder mucosa against inflammation and irritation. Intravesical LP has so far demonstrated an excellent safety profile and minimal toxicity at concentrations of 2 mg/ml. Thus, we hypothesize that intravesical instillation of LP may form a molecular film on bladder ulcer surfaces in patients with IC and provide a safe, effective, and minimally invasive treatment option to alleviating symptoms.
Eligibility Criteria
Inclusion Criteria
- • Written informed consent has been obtained
- Males and females, at least 18 years of age
- History of IC/PBS for at least 6 months documented in the medical record
- Recurring IC/PBS symptoms
- An average of 8 or more urine voids over a 3-day period, confirmed by the baseline voiding diary
- Bladder pain score > 4 in the last 24 hours (assessed at screening visit)
- Previous use of medications and/or treatment(s) for symptom relief
- Females of child-bearing capability agree to use a reliable form of birth control (condoms and/or oral contraceptives (birth control pills)) during the 4 week course of therapy and 1 week thereafter
- Willing and capable of understanding and complying with all requirements of the protocol, including proper completion of the voiding diaries and self-administered questionnaires
Exclusion Criteria
- • Subjects currently taking prescribed medications for IC/PBS will be able to continue the medications throughout the course of the study. If the patient cannot be maintained on a stable dose of the medication(s) throughout the treatment and follow-up period they will be excluded.
- Subjects must not have had intravesical treatment(s)/bladder installations of the following medications: dimethylsulfoxide (DMSO), lidocaine and/or heparin within 1 month prior to study visit 1
- Pregnant or lactating
- History of bleeding diathesis
- Currently on anticoagulant therapy (e.g. warfarin, clopidogrel)
- Active bleeding peptic ulcer disease
- Obvious neurological impairment which may be affecting bladder function
- Known allergy to liposomes and/or egg yolk
- Current or previous participation in another therapeutic or device study within 6 months of the screening visit
- The presence of any clinically significant systemic disease or condition that in the opinion of the investigator would make the patient unsuitable for the study
Data sourced from ClinicalTrials.gov (NCT01731470). 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.