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CompletedNCT01731470Updated Jan 10, 2017Results posted

Intravesical Liposomes for Interstitial Cystitis/Painful Bladder Syndrome (IC/PBS)

An interventional study of Liposomes in Interstitial Cystitis and Pelvic Pain, sponsored by Kenneth Peters, MD. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-01-10.

Sponsored by Kenneth Peters, MD · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
14
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

Read the detailed description

Liposomes (LP), the treatment article in this proposal, were discovered in the process of exploring a "control" compound when measuring the efficacy of liposomally encapsulated capsaicin for the intravesical treatment of interstitial cystitis. Liposomes are lipid vesicles composed of concentric phospholipid bilayers, which enclose an aqueous interior. Liposomes have the ability to form a molecular film on cell and tissue surfaces and are currently being tested as possible therapeutic agents to promote wound healing. Application of liposomes at the wound surface provides a moist protective film over the wound and augments wound healing without chronic inflammatory reactions in the neodermal layer.

02

Conditions studied

  • Interstitial Cystitis
  • Pelvic Pain
03

In context

Cystitis, Interstitial

227 studies on the registry are indexed under Cystitis, Interstitial; 32 are open to participants now.

This study's enrollment of 14 is below the median of 50 across 152 interventional studies indexed under Cystitis, Interstitial.

Browse Cystitis, Interstitial studies →

Lead sponsor

Kenneth Peters, MD is the lead sponsor of 16 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
14 participants (actual)

Study arms

  • Experimental
    Liposomes

    Liposomes

    Biological: Liposomes

Interventions

  • BiologicalLiposomes

    Intravesical instillation of liposomes.

06

What researchers measure

Primary outcomes

  1. 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

    The O'Leary-Sant IC Symptom Index (ICS-I) total score ranges from 0 to 20 and the Problem Index (ICP-I) total score ranges from 0 to 16. Each index has 4 questions and lower scores represent a better outcome. A total ICSI/ICPI score is obtained by adding the total scores from both indices. The combined ICSI/ICPI total score ranges from 0 to 36.

    Time frame: 4 and 8 weeks post-treatment

Secondary outcomes

  1. Change in Pain Scores at 4 and 8 Weeks Post-Treatment as Measured by the Visual Analog Scale (VAS)

    Patients utilized the Visual Analog Scale (VAS) to describe their pain. The scale ranges from 0:No pain to 10: Pain as bad as it could possibly be.

    Time frame: 4 and 8 weeks post-treatment

07

Results

Posted Jan 10, 2017
Limitations and caveats
This was an open-label trial without evaluation of placebo effects.

Participant flow

Participant flow — Overall Study
MilestoneLiposomes
Started16
Completed14
Not completed2
Withdrew: Withdrawal by subject1
Withdrew: Did not meet study criteria1

Outcome measures

PrimaryChange 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

The O'Leary-Sant IC Symptom Index (ICS-I) total score ranges from 0 to 20 and the Problem Index (ICP-I) total score ranges from 0 to 16. Each index has 4 questions and lower scores represent a better outcome. A total ICSI/ICPI score is obtained by adding the total scores from both indices. The combined ICSI/ICPI total score ranges from 0 to 36.

Time frame:
4 and 8 weeks post-treatment
Reported as:
Median · units on a scale
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
units on a scaleLiposomes
Baseline to 4 Weeks Post Treatment-4 (-7 to -1)
Baseline to 8 Weeks Post Treatment-4 (-8 to -1)
SecondaryChange in Pain Scores at 4 and 8 Weeks Post-Treatment as Measured by the Visual Analog Scale (VAS)

Patients utilized the Visual Analog Scale (VAS) to describe their pain. The scale ranges from 0:No pain to 10: Pain as bad as it could possibly be.

Time frame:
4 and 8 weeks post-treatment
Reported as:
Mean · units on a scale
Change in Pain Scores at 4 and 8 Weeks Post-Treatment as Measured by the Visual Analog Scale (VAS)
units on a scaleLiposomes
Baseline to 4 Weeks Post-2 (-3.82 to 0.00)
Baseline to 8 Weeks Post-Treatment-1.14 (-3.90 to -0.90)

Adverse events

Collected over Adverse event data were collected for approximately 12 weeks, from the first treatment visit through 8 weeks post-treatment.. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Liposomes—0/14 (0%)4/14 (28.6%)
Most frequent other events
Most frequent other events
EventLiposomes
HematuriaRenal and urinary disorders1/14
Irritable BowelGastrointestinal disorders1/14
Muscle PullMusculoskeletal and connective tissue disorders1/14
InfectionRenal and urinary disorders1/14
NauseaGastrointestinal disorders1/14
Pinched NerveMusculoskeletal and connective tissue disorders1/14
FractureMusculoskeletal and connective tissue disorders1/14
PneumoniaRespiratory, thoracic and mediastinal disorders1/14

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)Liposomes
<=18 years0
Between 18 and 65 years12
>=65 years4
Gender
Gender(Participants)Liposomes
Female13
Male3
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Liposomes
American Indian or Alaska Native0
Asian0
Native Hawaiian or Other Pacific Islander0
Black or African American1
White15
More than one race0
Unknown or Not Reported0
Region of Enrollment
Region of Enrollment(participants)Liposomes
United States16
08

Study locations

1 site
  • William Beaumont Hospital
    Royal Oak, Michigan 48073, United States
09

References and documents

Publications

  • Peters KM, Hasenau D, Killinger KA, Chancellor MB, Anthony M, Kaufman J. Liposomal bladder instillations for IC/BPS: an open-label clinical evaluation. Int Urol Nephrol. 2014 Dec;46(12):2291-5. doi: 10.1007/s11255-014-0828-5. Epub 2014 Sep 11. PubMed 25209396 ↗

Individual participant data

Plan to share: No — No plan to share data

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 10, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT01731470
Lead sponsor
Kenneth Peters, MD
Collaborators
Corewell Health East
Responsible party
Kenneth Peters, MD (Principal Investigator, Corewell Health East) — Sponsor-investigator
First posted
Nov 21, 2012
Start date
Jul 2012
Primary completion
Aug 2013
Completion
Aug 2013
Results posted
Jan 10, 2017
Last update
Jan 10, 2017

Study contacts

Kenneth M Peters, MD
principal investigator · Corewell Health East

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2016. You cannot join it, but the record below documents what was studied.

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