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NCT01731470 · ClinicalTrials.gov registry record · NA

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

A NA study of Interstitial Cystitis and Pelvic Pain, sponsored by Kenneth Peters, MD.

Completed
Registry status
NA
Development phase
14
Enrollment target
1
Study location

NCT01731470: Completed NA study of Interstitial Cystitis and Pelvic Pain, sponsored by Kenneth Peters, MD.

NCT01731470 is a NA study of Interstitial Cystitis and Pelvic Pain that has completed, run by Kenneth Peters, MD. The registered enrollment target is 14 participants, below the 362-participant average among 26 other Interstitial Cystitis trials with a reported enrollment target (96% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01731470, a NA study of Interstitial Cystitis and Pelvic Pain, has completed, sponsored by Kenneth Peters, MD.

COMPLETED
Registry status
NA
Development phase
14 participants
Enrollment target
1
Study location

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.

Primary Outcome

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.

Interventions

  • BIOLOGICAL Liposomes

Study Locations (1)

Michigan

  • William Beaumont Hospital - Royal Oak

Trial Details

FieldValue
Enrollment Target 14 participants
Start Date 2012-07
Est. Completion 2013-08
Phase NA
Kenneth Peters, MD

14 total trials

What the finished NCT01731470 record still lists

NCT01731470 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 14 participants, a relatively small participant target, below the 362-participant average among 26 other Interstitial Cystitis trials with a reported enrollment target (96% lower).

The record links to 2 conditions, with Interstitial Cystitis appearing as the primary indexed condition, and to 1 intervention - of which Liposomes is the first listed.

NCT01731470 reports a single indexed study location in Michigan.

Frequently Asked Questions

What is clinical trial NCT01731470 about?

NCT01731470 is a clinical study titled "Intravesical Liposomes for Interstitial Cystitis/Painful Bladder Syndrome (IC/PBS)". 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...

What is the current status of trial NCT01731470?

This trial is currently completed. It is a NA study. The enrollment target is 14 participants. The study started on 2012-07. Estimated completion is 2013-08.

What conditions does trial NCT01731470 study?

This clinical trial studies the following conditions: Interstitial Cystitis, Pelvic Pain.

What interventions are being tested in trial NCT01731470?

The interventions under investigation include: Liposomes (BIOLOGICAL).

Who is sponsoring clinical trial NCT01731470?

This trial is sponsored by Kenneth Peters, MD, which has 14 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01731470 being conducted?

This trial has 1 study location across Michigan. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Similar trials for Interstitial Cystitis

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT01731470's enrollment target sits among peer trials

14 24th of 26 higher than 2 of 26 other Interstitial Cystitis trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Interstitial Cystitis trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT01731470, the US trial registry maintained by the National Library of Medicine. NCT01731470 (small enrollment · single site footprint · completed) retrieved and formatted by PlainTrial, see methodology.