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

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2013 by Buddhist Tzu Chi General Hospital
Sponsor:
Information provided by (Responsible Party):
Hann-Chorng Kuo, Buddhist Tzu Chi General Hospital
ClinicalTrials.gov Identifier:
NCT01969773
First received: October 22, 2013
Last updated: NA
Last verified: October 2013
History: No changes posted
  Purpose

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 Intervention Phase
Interstitial Cystitis
Drug: Botulinum toxin A
Drug: Normal saline instillation
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
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

Resource links provided by NLM:


Further study details as provided by Buddhist Tzu Chi General Hospital:

Primary Outcome Measures:
  • Net change of Patient Perception of Visual Analogue Scale (VAS) [ Time Frame: Baseline and 8 weeks ] [ Designated as safety issue: No ]

    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:
  • Net change of Patient Perception of global response assessment (GRA) [ Time Frame: Baseline and 8 weeks ] [ Designated as safety issue: No ]

    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


  • Net change of O'Leary-Sant symptom and problem indexes [ Time Frame: Baseline and 8 weeks ] [ Designated as safety issue: No ]

    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


  • Net change of the functional bladder capacity (FBC) [ Time Frame: Baseline and 8 weeks ] [ Designated as safety issue: No ]

    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


  • Net change of the number of urinary frequency [ Time Frame: Baseline and 8 weeks ] [ Designated as safety issue: No ]

    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


  • Net change of the number of nocturnal [ Time Frame: Baseline and 8 weeks ] [ Designated as safety issue: No ]

    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


  • Net change of the Quality of Life (QoL) [ Time Frame: Baseline and 8 weeks ] [ Designated as safety issue: No ]

    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


  • Net change of the maximal flow rate (Qmax) [ Time Frame: Baseline and 8 weeks ] [ Designated as safety issue: No ]

    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


  • Net change of the voided volume [ Time Frame: Baseline and 8 weeks ] [ Designated as safety issue: Yes ]

    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


  • Net change of the residual urine volume (PVR) [ Time Frame: Baseline and 8 weeks ] [ Designated as safety issue: Yes ]

    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



Estimated Enrollment: 90
Study Start Date: December 2012
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   20 Years to 85 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01969773

Contacts
Contact: Hann-Chorng Kuo, M.D. 886-3-8561825 ext 2113 hck@tzuchi.com.tw
Contact: Dong-Ling Tang, Miss 886-3-8561825 ext 2117 don_lin86@yahoo.com.tw

Locations
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
Principal Investigator: Hann-Chorng Kuo, M.D. Department of Urology, Buddhist Tzu Chi General Hospital and Tzu Chi University
  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
Study First Received: October 22, 2013
Last Updated: October 22, 2013
Health Authority: Taiwan: Department of Health
Taiwan: Research Ethics Committee

Keywords provided by 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, Type A
Botulinum Toxins
Neuromuscular Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Dyskinesia Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 22, 2014