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Comparative Study Suburothelial and Trigonal Botulinum Toxin A Injection in Treatment of Interstitial Cystitis

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ClinicalTrials.gov Identifier: NCT03076762
Recruitment Status : Unknown
Verified April 2017 by Hann-Chorng Kuo, Buddhist Tzu Chi General Hospital.
Recruitment status was:  Recruiting
First Posted : March 10, 2017
Last Update Posted : April 7, 2017
Sponsor:
Information provided by (Responsible Party):
Hann-Chorng Kuo, Buddhist Tzu Chi General Hospital

Brief Summary:
There is no consensus of the therapeutic efficacy and safety between suburothelial injection and trigonal injection of botulinum toxin A (BoNT-A) in treatment of interstitial cystitis/bladder pain syndrome (IC/BPS) It is unmet to clarify which injection method is superior in clinical efficacy and patient safety. This study was designed in a randomized, double-blind trial to test the therapeutic effects and adverse events between intravesical BoNTA injection into suburothelium and trigone. The results of this study might provide clinical evidence for a better therapeutic regimen of BoNT-A in the treatment of IC/PBS.

Condition or disease Intervention/treatment Phase
Bladder Pain Syndrome Drug: intravesical onabotulinumtoxinA injection Phase 2

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Eligible patients will be randomly assigned to receive intravesical injection of 100U of BoNT-A (BOTOX, Allergan, Irvine, CA, USA) into the trigone (the treatment group) or suburothelium (the comparative group) immediately followed by cystoscopic hydrodistention under intravenous general anesthesia in the operation room.
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Masking Description: Participants, investigator and outcome assessor are blinded to the treatment arm.
Primary Purpose: Treatment
Official Title: Comparative Study of the Efficacy and Safety Between Suburothelial and Trigonal Intravesical Botulinum Toxin A Injection in Treatment of Interstitial Cystitis Refractory to Conventional Treatment - A Prospective, Randomized, Clinical Trial
Actual Study Start Date : March 2015
Estimated Primary Completion Date : August 2017
Estimated Study Completion Date : August 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Intravesical suburothelial injection
Patients assigned for suburothelial injections received 100 U of onabotulinumtoxinA in 20 sites injected in the bladder body on treatment day and follow-up
Drug: intravesical onabotulinumtoxinA injection
Each vial of onabotulinumtoxinA will be diluted with 10 ml of normal saline, resulting in 10U onabotulinumtoxinA per 1.0 ml. Patients assigned for suburothelial BoNT-A injections received 20 injections in the bladder body whereas those assigned trigonal injections will receive 10 sites injections at the trigonal area (5 injections behind interureteric ridge and 5 inside the trigone).
Other Name: BOTOX

Active Comparator: Intravesical trigonal injection
Patients assigned trigonal injections will receive 100U of onabotulinumtoxinA at 10 sites injected at the trigonal area (5 injections behind interureteric ridge and 5 inside the trigone) on treatment day and follow-up.
Drug: intravesical onabotulinumtoxinA injection
Each vial of onabotulinumtoxinA will be diluted with 10 ml of normal saline, resulting in 10U onabotulinumtoxinA per 1.0 ml. Patients assigned for suburothelial BoNT-A injections received 20 injections in the bladder body whereas those assigned trigonal injections will receive 10 sites injections at the trigonal area (5 injections behind interureteric ridge and 5 inside the trigone).
Other Name: BOTOX




Primary Outcome Measures :
  1. Reduction of bladder pain visual analog scale (VAS) [ Time Frame: baseline to 8 weeks ]
    Evaluation of the change of VAS from baseline to 8 weeks


Secondary Outcome Measures :
  1. Interstitial cystitis symptom index (ICSI) [ Time Frame: baseline to 8 weeks ]
    Evaluation of the change of ICSI froim baseline to 8 weeks

  2. Functional bladder capacity [ Time Frame: baseline to 8 weeks ]
    The change of maximal bladder capacity in voiding diary from baseline to 8 weeks

  3. Maximum flow rate (Qmax) [ Time Frame: baseline to 8 weeks ]
    The change of Qmax from baseline to 8 weeks

  4. Voided volume [ Time Frame: baseline to 8 weeks ]
    Thde change of voided volume from baseline to 8 weeks

  5. Postvoid residual volume [ Time Frame: baseline to 8 weeks ]
    The change of postvoid residual volume from baseline to 8 weeks

  6. Interstitial cystitis problem index (ICPI) [ Time Frame: baseline to 8 weeks ]
    Evaluation of the change of ICPI from baseline to 8 weeks



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients have been diagnosed as IC/BPS based on characteristic symptoms and cystoscopic findings of glomerulations, petechia, or mucosal fissures after hydrodistention
  2. Patients have been treated with at least two types of treatment modalities including non-steroid anti-inflammatory drugs, oral PPS, intravesical instillation of heparin, hyaluronic acid, or tricyclic antidepressant for at least 6 months but the symptoms remained unchanged or relapsed.
  3. Patients who have bladder pain VAS of 3 or greater

Exclusion Criteria:

  1. Patients conditions not meeting the inclusion criteria of NIDDK
  2. Patients with Hunner's ulcer
  3. Patients with active urinary tract infection
  4. Patients who cannot keep a 3-day voiding diary prior to treatment
  5. Patients who do not sign informed consent form

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03076762


Contacts
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Contact: Hann-Chorng HC Kuo, M.D. 886-3-8561825 ext 2113 hck@tzuchi.com.tw
Contact: Dong-Ling DL Tang, Miss 886-3-8561825 ext 2117 hck@tzuchi.com.tw

Locations
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Taiwan
Buddhist Tzu Chi General Hospital Recruiting
Hualien, Taiwan, 970
Contact: Hann-Chorng Kuo, M.D.    886-3-8561825 ext 2113    hck@tzuchi.com.tw   
Contact: Tang, Miss    886-3-8561825 ext 2117    don_lin86@yahoo.com.tw   
Sponsors and Collaborators
Buddhist Tzu Chi General Hospital
Investigators
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Principal Investigator: Hann-Chorng HC Kuo, M.D. Department of Urology, Buddhist Tzu Chi General Hospital, Hualien

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Responsible Party: Hann-Chorng Kuo, Chairman, Department of Urology, Buddhist Tzu Chi General Hospital
ClinicalTrials.gov Identifier: NCT03076762     History of Changes
Other Study ID Numbers: BuddhistTCGH2003-01
First Posted: March 10, 2017    Key Record Dates
Last Update Posted: April 7, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: No plan to share IPD

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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.: Yes

Keywords provided by Hann-Chorng Kuo, Buddhist Tzu Chi General Hospital:
interstitial cystitis
pain
intravesical injection
therapy
bladder

Additional relevant MeSH terms:
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Cystitis
Cystitis, Interstitial
Urinary Bladder Diseases
Urologic Diseases
Botulinum Toxins
Botulinum Toxins, Type A
abobotulinumtoxinA
Acetylcholine Release Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Neuromuscular Agents
Peripheral Nervous System Agents