Intravesical Instillation of Liposome Encapsulated Botulinum Toxin A (Lipotoxin) in Treatment of Interstitial Cystitis

March 7, 2017 updated by: Hann-Chorng Kuo, Buddhist Tzu Chi General Hospital

Intravesical Instillation of Liposome Encapsulated Botulinum Toxin A (Lipotoxin) in Treatment of Interstitial Cystitis - a Randomized, Double-blind, Placebo-controlled, Prospective Study

To evaluate the efficacy and safety of intravesical instillation of Lipotoxin for the treatment of IC/BPS

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Liposome has been proven able to carry botulinum toxin protein across the cell membrane and effect on urothelial receptors in human overactive bladder. However, the therapeutic duration is limited to 1 month. Intravesical BOTOX injection in patients with interstitial cystitis (IC) can effectively decrease pain, improve bladder capacity and decrease frequency. However, the need of cystoscopic injection limits its wide application.

A total of 100 eligible women with non-ulcer IC will be enrolled to receive intravesical instillation of Lipotoxin containing 80mg liposomes and 200U BOTOX (treatment group), 200U BOTOX in normal saline (N/S) (active control group) or normal saline (placebo control group) single treatment. At least 90 evaluable patients will be included for the final analysis.

All patients should have IC symptoms for at least 6 months, and proven to have grade 2 diffused glomerulations after cystoscopic hydrodistention (HD) within recent 1 year without Hunner's lesion. Patients should not have UTI in recent 12 months, no urinary tract stone. Patients should have been proven free of detrusor overactivity or bladder outlet obstruction. Patients should not receive intravesical hyaluronic acid treatment in recent 6 months, or intravesical Botox injection in recent 12 months. Intravesical instillation of Lipotoxin at OPD and the patient should hold the solution for 2 hours to allow bladder distention. Retreatment with Lipotoxin at 3 months if patient reports ineffective.

Primary end-point is the change of the O'Leary-Sant symptom score (including ICSI and ICPI) from baseline to 1 month after treatment. Secondary endpoints include VAS, daily frequency, nocturia and FBC as record in 3-day voiding diary, Qmax, voided volume, PVR and global response assessment (GRA). Four visits are required at baseline screening (before first treatment), treatment (V1), 2 weeks (V2), 4 weeks (V3, primary end-point) and 12 weeks (V4).

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
90

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Hualien, Taiwan, 970
        • Buddhist Tzu Chi General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

20 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Adults with age of 20 years old or above
  2. Patients with symptoms of frequency, urgency, nocturia, and/or bladder pain.
  3. Proven to have glomerulations (at least grade 2) by cystoscopic hydrodistention under anesthesia in recent 1 year
  4. Free of active urinary tract infection
  5. Free of bladder outlet obstruction on enrollment
  6. Free of overt neurogenic bladder dysfunction and limitation of ambulation
  7. Patient or his/her legally acceptable representative has signed the written informed consent form

Exclusion Criteria:

  1. Hunner's lesion proven by cystoscopy
  2. Patients with severe cardiopulmonary disease and such as congestive heart failure, arrhythmia, poorly controlled hypertension, not able to receive regular follow-up
  3. Patients with bladder outlet obstruction on enrollment
  4. Patients with postvoid residual >250ml
  5. Patients with uncontrolled confirmed diagnosis of acute urinary tract infection
  6. Patients have laboratory abnormalities at screening including: ALT> 3 x upper limit of normal range, AST> 3 x upper limit of normal range; Patients have abnormal serum creatinine level > 2 x upper limit of normal range
  7. Patients with any contraindication to be urethral catheterization during treatment
  8. Female patients who is pregnant, lactating, or with child-bearing potential without contraception.
  9. Myasthenia gravis, Eaton Lambert syndrome.
  10. Patients with any other serious disease considered by the investigator not in the condition to enter the trial
  11. Patient had received intravesical treatment for IC within recent 1 month
  12. Patients participated investigational drug trial within 1 month before entering this study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Group A: Liposome encapsulated BoNT-A
Liposome encapsulated BoNT-A ( mixed BOTOX 200U/10ml in Liposome 80mg/40ml) in single intravesical instillation
Drug: Liposome encapsulated BoNT-A
Liposome encapsulated BoNT-A ( mixed BOTOX 200U/10ml in Liposome 80mg/40ml) in single intravesical instillation
Other Names:
  • Liposome
  • onabotulinumtoxinA 200U
Experimental: Group B: BoNT-A 200 U in Normal saline
BOTOX 200U in normal saline (BoNT-A/NS) 50ml in single intravesical instillation
Drug: BOTOX 200U in normal saline
BOTOX 200U in normal saline (BoNT-A/NS) 50ml in single intravesical instillation
Other Names:
  • onabotulinumtoxinA 200U
Placebo Comparator: Group C: Normal saline
Normal saline (N/S) 50ml in single intravesical instillation
Drug: Normal saline
Normal saline (N/S) 50ml in single intravesical instillation
Other Names:
  • Saline

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change of the O'Leary-Sant symptom score
Time Frame: Baseline and 1 month
Change of the O'Leary-Sant symptom score from baseline to 1 month after the treatment day
Baseline and 1 month

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Net changes of the Visual Analog Scale (VAS)
Time Frame: Baseline and 1 month

Net changes of the Visual Analog Scale from baseline to 1 month after the treatment day

Safety

(1) Local adverse event incidences (hematuria, miction pain, UTI, urinary retention).
Baseline and 1 month
Net changes of the functional bladder capacity (FBC)
Time Frame: Baseline and 1 month

Net changes of the functional bladder capacity from baseline to 1 month after the treatment day

Safety

(1) Local adverse event incidences (hematuria, miction pain, UTI, urinary retention).
Baseline and 1 month
Net changes of the voiding frequency at daytime as recorded in 3-day voiding diary
Time Frame: Baseline and 1 month

Net changes of the voiding frequency at daytime from baseline to 1 month after the treatment day

Safety

(1) Local adverse event incidences (hematuria, miction pain, UTI, urinary retention).
Baseline and 1 month
Net changes of the voiding frequency at night time as recorded in 3-day voiding diary
Time Frame: Baseline and 1 month

Net changes of the voiding night time from baseline to 1 month after the treatment day

Safety

(1) Local adverse event incidences (hematuria, miction pain, UTI, urinary retention).
Baseline and 1 month
Net Change of the Global response assessment (GRA)
Time Frame: Baseline and 1 month

Global response assessment (GRA) of therapeutic result by the patient (categorized from -3 to +3, indicating markedly worse to markedly improved) at 3 months after the treatment day.

Safety

(1) Local adverse event incidences (hematuria, miction pain, UTI, urinary retention).
Baseline and 1 month
Net Change of the maximum flow rate
Time Frame: Baseline and 1 month

Net changes of the maximum flow rate from baseline to 1 month after the treatment day.

Safety

(1) Local adverse event incidences (hematuria, miction pain, UTI, urinary retention).
Baseline and 1 month
Net Change of the voided volume
Time Frame: Baseline and 1 month

Net changes of the voided volume from baseline to 1 month after the treatment day.

Safety

(1) Local adverse event incidences (hematuria, miction pain, UTI, urinary retention).
Baseline and 1 month
Net Change of the PVR
Time Frame: Baseline and 1 month

Net changes of the PVR from baseline to 1 month after the treatment day.

Safety

(1) Local adverse event incidences (hematuria, miction pain, UTI, urinary retention).
Baseline and 1 month
Net Change of the urinary nerve growth factor
Time Frame: Baseline and 1 month

Changes of urinary nerve growth factor from baseline to 1 month after treatment day.

Safety

(1) Local adverse event incidences (hematuria, miction pain, UTI, urinary retention).
Baseline and 1 month
Net Change of the cytokines level
Time Frame: Baseline and 1 month

Changes of cytokines level from baseline to 1 month after treatment day.

Safety

(1) Local adverse event incidences (hematuria, miction pain, UTI, urinary retention).
Baseline and 1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Buddhist Tzu Chi General Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Hann-Chorng Kuo, M.D., Department of Urology, Buddihisst Tzu Chi General Hospital and Tzu Chi University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2014

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 1, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 1, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 15, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 23, 2014

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 25, 2014

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 9, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 7, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • TCGHUROL011

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

IPD cannot be released unless researchers obtain the approval from the Ethics Committee of the Buddhist Tzu Chi General Hospital, Hualien, Taiwan

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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