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Intravesical Botulinum Toxin A Injections in Treatment of Interstitial Cystitis Refractory to Conventional Treatment

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ClinicalTrials.gov Identifier: NCT01969773
Recruitment Status : Completed
First Posted : October 25, 2013
Last Update Posted : February 17, 2017
Sponsor:
Information provided by (Responsible Party):
Hann-Chorng Kuo, Buddhist Tzu Chi General Hospital

Study Description
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Brief Summary:
This study was designed in a multicenter, randomized, double-blind, placebo controlled trial to test the actual therapeutic effects of intravesical BoNTA injection. The results of this study might provide clinical evidence for a better therapeutic regimen in the treatment of IC/PBS.

Condition or disease Intervention/treatment Phase
Interstitial Cystitis Drug: Botulinum toxin A Drug: Normal saline instillation Phase 2

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Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Intervention Model Description: The patients were allocated to the treatment or control group by permuted block randomization code in a 2:1 ratio
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: The attending doctors, patients, and study nurses did not know which solution was injected to their bladders, to keep the study in a double-blind condition.
Primary Purpose: Treatment
Official Title: Intravesical Botulinum Toxin A Injection in Treatment of Interstitial Cystitis Refractory to Conventional Treatment - A Prospective, Multicenter, Randomized, Double-blind, Placebo-controlled Clinical Trial
Actual Study Start Date : December 2012
Actual Primary Completion Date : December 2014
Actual Study Completion Date : December 2014

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U.S. FDA Resources

Arms and Interventions
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Arm Intervention/treatment
Experimental: Botulinum toxin A
Patients will be randomly assigned to receive intravesical injection of 100U of BoNT-A (BOTOX, Allergan, Irvine, CA, USA)
 Drug: Botulinum toxin A
Patients will be randomly assigned to receive intravesical injection of 100U of BoNT-A (BOTOX, Allergan, Irvine, CA, USA)
Other Names:
  • BoNT-A
  • BOTOX
Placebo Comparator: Control arm-Normal saline instillation
Patients will be randomly assigned to receive intravesical injection of injection with normal saline.
 Drug: Normal saline instillation
Patients will be randomly assigned to receive intravesical injection of injection with normal saline.
Other Name: N/S


Outcome Measures
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Primary Outcome Measures :
  1. Net change of Patient Perception of Visual Analogue Scale (VAS) [ Time Frame: Baseline and 8 weeks ]

    Efficacy:

    The primary end-point of this study is the reduction of bladder pain at 8-week follow-up. If patient has a reduction of VAS pain score of 2 or more, they will be considered as successfully treated at baseline and 8 weeks after BoNT-A injection within and between the treatment group and control groups.

    Safety:

    Systemic adverse events



Secondary Outcome Measures :
  1. Net change of Patient Perception of global response assessment (GRA) [ Time Frame: Baseline and 8 weeks ]

    Efficacy:

    The treatment outcome will be assessed by the global response assessment (GRA) to evaluate the overall perception of treatment resultant at baseline and 8 weeks after BoNT-A injection within and between the treatment group and control groups.

    Safety:

    Systemic adverse events


  2. Net change of O'Leary-Sant symptom and problem indexes [ Time Frame: Baseline and 8 weeks ]

    Efficacy:

    The IC symptoms will be assessed by the O'Leary-Sant symptom and problem indexes at baseline and 8 weeks after BoNT-A injection within and between the treatment group and control groups.

    Safety:

    Systemic adverse events


  3. Net change of the functional bladder capacity (FBC) [ Time Frame: Baseline and 8 weeks ]

    Efficacy:

    Patients will be requested to keep a 3-day voiding diary prior to treatment to record the functional bladder capacity (FBC). Then the patients will be followed up at out-patient clinic at 8 weeks.

    Safety:

    Systemic adverse events


  4. Net change of the number of urinary frequency [ Time Frame: Baseline and 8 weeks ]

    Efficacy:

    Patients will be requested to keep a 3-day voiding diary prior to treatment to record the number of urinary frequency at baseline and 8 weeks after BoNT-A injection within and between the treatment group and control groups.

    Safety:

    Systemic adverse events


  5. Net change of the number of nocturnal [ Time Frame: Baseline and 8 weeks ]

    Efficacy:

    Patients will be requested to keep a 3-day voiding diary prior to treatment to record the number of nocturnal at baseline and 8 weeks after BoNT-A injection within and between the treatment group and control groups.

    Safety:

    Systemic adverse events


  6. Net change of the Quality of Life (QoL) [ Time Frame: Baseline and 8 weeks ]

    Efficacy:

    Efficacy measured the net change of the Quality of Life (QoL) at baseline and 8 weeks after BoNT-A injection within and between the treatment group and control groups.

    Safety:

    Systemic adverse events


  7. Net change of the maximal flow rate (Qmax) [ Time Frame: Baseline and 8 weeks ]

    Efficacy:

    Efficacy measured the net change of the maximal flow rate (Qmax) at baseline and 8 weeks after BoNT-A injection within and between the treatment group and control groups.

    Safety:

    Systemic adverse events


  8. Net change of the voided volume [ Time Frame: Baseline and 8 weeks ]

    Efficacy:

    Efficacy measured the net change of the voided volume at baseline and 8 weeks after BoNT-A injection within and between the treatment group and control groups.

    Safety:

    Systemic adverse events


  9. Net change of the residual urine volume (PVR) [ Time Frame: Baseline and 8 weeks ]

    Efficacy:

    Efficacy measured the net change of the residual urine volume (PVR) at baseline and 8 weeks after BoNT-A injection within and between the treatment group and control groups.

    Safety:

    Systemic adverse events



Eligibility Criteria
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Ages Eligible for Study:   20 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with IC/PBS who have failed conventional treatments for at least 6 months will be enrolled.
  • A diagnosis of IC/PBS has been established based on characteristic symptoms and cystoscopic findings of glomerulations, petechia, or mucosal fissures after hydrodistention.
  • All patients have been treated with at least two types of treatment modalities including non-steroid anti-inflammatory drugs, oral pentosan polysulfate sodium (PPS), intravesical instillation of heparin, hyaluronic acid, or tricyclic antidepressant for at least 6 months but the symptoms remained unchanged or relapsed.

Exclusion Criteria:

  • Exclusion criteria proposed by NIDDK

  • Automatic exclusions:

    1. Age <18 years old
    2. Benign or malignant bladder tumors
    3. Radiation cystitis Tuberculous cystitis
    4. Bacterial cystitis
    5. Vaginitis
    6. Cyclophosphamide cystitis
    7. Symptomatic urethral diverticulum
    8. Uterine, cervical, vaginal, or urethral cancer
    9. Active herpes
    10. Bladder or lower ureteral calculi
    11. Waking frequency <5 times in 12 hours
    12. Nocturia <2 times
    13. Symptoms relieved by antibiotics, urinary antiseptics, urinary analgesics (for example phenazopyridine hydrochloride)
    14. Duration < 12 months
    15. Involuntary bladder contractions (urodynamics)
    16. Capacity > 400ml, absence of sensory urgency

  • Automatic inclusions:

    1.Hunner's ulcer

  • Positive factors: (two positive factors are necessary for inclusion)

    1. Pain on bladder filling relieved by emptying
    2. Pain (suprapubic, pelvic, urethral, vaginal or peripheral)
    3. Glomerulations on endoscopy
    4. Decreased compliance on cystometrogram
    5. Bladder distention is defined arbitrarily as 80 cm water pressure for 1 minute
  • Use of Anticholinergic drugs, for the treatment of lower urinary tract symptoms who have an effect.
  • Patients with severe cardiopulmonary disease and such as congestive heart failure, arrhythmia, poorly controlled hypertension, not able to receive regular follow-up.
  • Patients with bladder outlet obstruction on enrollment.
  • Patients with urinary retention, PVR≥150 ml.
  • Patients with uncontrolled confirmed diagnosis of acute urinary tract infection.

  • Patients have laboratory abnormalities at screening including:

    1. Alanine aminotransferase (ALT) > 3 x upper limit of normal range
    2. Aspartate aminotransferase (AST) > 3 x upper limit of normal range.
    3. Patients have abnormal serum creatinine level > 2 x upper limit of normal range.
  • Can not be used in the treatment of patients with transurethral catheter treatment.
  • Pregnant and lactating women or women who intend to become pregnant during the study or have myasthenia gravis, Eaton Lambert syndrome.
  • Patients with any other serious disease or condition considered by the investigator not suitable for entry into the trial.
  • Patients participated investigational drug trial within 1 month before entering this study.
  • Written informed consent has been obtained.
  • Patient who did not complete the 3-day micturition diary according to the instruction.
  • Intestinal bladder augmentation patients receive angioplasty for the treatment of overactive bladder.
Contacts and Locations
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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): NCT01969773


Locations
Taiwan
Buddhist Tzu Chi General Hospital
Hualien, Taiwan, 970
Sponsors and Collaborators
Buddhist Tzu Chi General Hospital
Investigators
Principal Investigator: Hann-Chorng Kuo, M.D. Department of Urology, Buddhist Tzu Chi General Hospital and Tzu Chi University
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications:

Responsible Party: Hann-Chorng Kuo, Director of Urology, Buddhist Tzu Chi General Hospital
ClinicalTrials.gov Identifier: NCT01969773     History of Changes
Other Study ID Numbers: TCGHUROL009
First Posted: October 25, 2013    Key Record Dates
Last Update Posted: February 17, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: IPD was not planned to share

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:
Botulinum Toxin A (BoNT-A)
Interstitial Cystitis

Additional relevant MeSH terms:
Cystitis
Cystitis, Interstitial
Urinary Bladder Diseases
Urologic Diseases
Botulinum Toxins
Botulinum Toxins, Type A
onabotulinumtoxinA
abobotulinumtoxinA
incobotulinumtoxinA
 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