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Injections of Botulinum Toxin A in Treatment of Patients With Detrusor Overactivity and Impaired Contractility

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ClinicalTrials.gov Identifier: NCT02135341
Recruitment Status : Completed
First Posted : May 9, 2014
Last Update Posted : February 15, 2017
Sponsor:
Information provided by (Responsible Party):
Hann-Chorng Kuo, Buddhist Tzu Chi General Hospital

Brief Summary:
The objectives of this study is to evaluate and compare the efficacy and safety between 100 U of botulinum toxin A (BoNT-A) suburothelial injections and combined 50 U of BoNT-A suburothelial injections and 50 U urethral injection for the treatment of detrusor overactivity and inadequate contractility (DHIC) refractory to antimuscarinic agents

Condition or disease Intervention/treatment Phase
Botulinum Toxins, Type A Drug: Botulinum toxin A Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Patients with urodynamically proven DHIC and age-matched controlled OAB patients with urodynamic DO selected from our previous clinical trials were compared for the treatment outcome of onabotulinumtoxinA injection
Masking: None (Open Label)
Masking Description: No masking was designed in this study
Primary Purpose: Treatment
Official Title: Comparative Study of Safety and Efficacy Between 100 U Suburothelial Injection and 50 U Suburothelial Plus 50 U Urethral Injections of Botulinum Toxin A in Treatment of Patients With Detrusor Overactivity and Impaired Contractility
Actual Study Start Date : May 2014
Actual Primary Completion Date : December 2016
Actual Study Completion Date : December 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Botox

Arm Intervention/treatment
Experimental: Group A: Botulinum toxin A
BoNT-A 100 units in normal saline 10ml, suburothelial injection at 20 sites of bladder wall in single treatment
Drug: Botulinum toxin A
BoNT-A 100 units in normal saline 10ml, suburothelial injection at 20 sites of bladder wall in single treatment
Other Names:
  • BoNT-A
  • BOTOX (Allergan, Irvine, CA, USA)

Experimental: Group B: Botulinum toxin A
BoNT-A 100 units in normal saline 10ml, suburothelial injection 50 U in 10 sites and 50 U urethral injections in 5 sites
Drug: Botulinum toxin A
BoNT-A 100 units in normal saline 10ml, suburothelial injection 50 U in 10 sites and 50 U urethral injections in 5 sites
Other Names:
  • BoNT-A
  • BOTOX (Allergan, Irvine, CA, USA)




Primary Outcome Measures :
  1. Net change of the Patients Perception of Bladder Condition (PPBC) [ Time Frame: Baseline and 3 months ]

    Net change of the Patients Perception of Bladder Condition (PPBC, scored from 1 to 6) from baseline to 3 months after the treatment day.

    Safety:

    1. Local adverse event incidences (hematuria, micturition pain, urinary tract infection (UTI), urinary retention)
    2. Systemic adverse events.

    Safety:

    Systemic adverse events



Secondary Outcome Measures :
  1. Net change of the International Prostate Symptom Score (IPSS) [ Time Frame: Baseline and 3 months ]
    Net change of the following parameters from baseline to 3 month after the treatment day: lower urinary tract symptom score (including empty and storage IPSS)

  2. Net change of the bladder capacity [ Time Frame: Baseline and 3 months ]

    Efficacy:

    Net change of the following parameters from baseline to 3 month after the treatment day: bladder capacity

    Safety:

    Local adverse event incidences (hematuria, micturition pain, UTI, urinary retention) Systemic adverse events.


  3. Net change of the voiding frequency at daytime [ Time Frame: Baseline and 3 months ]

    Efficacy:

    Net change of the following parameters from baseline to 3 month after the treatment day: voiding frequency at daytime.

    Safety:

    Local adverse event incidences (hematuria, micturition pain, UTI, urinary retention) Systemic adverse events.


  4. Net change of the voiding frequency at night time [ Time Frame: Baseline and 3 months ]

    Efficacy:

    Net change of the following parameters from baseline to 3 month after the treatment day: voiding frequency at night time.

    Safety:

    Local adverse event incidences (hematuria, micturition pain, UTI, urinary retention) Systemic adverse events.


  5. Net change of voiding urgency severity score [ Time Frame: Baseline and 3 months ]

    Efficacy:

    Net change of the following parameters from baseline to 3 month after the treatment day: urgency severity score

    Safety:

    Local adverse event incidences (hematuria, micturition pain, UTI, urinary retention) Systemic adverse events.


  6. Net change of the first sensation of bladder filling [ Time Frame: Baseline and 3 months ]

    Efficacy:

    Net change of the urodynamic parameters: first sensation of bladder filling from baseline to 3 months after the treatment day.

    Safety:

    Local adverse event incidences (hematuria, micturition pain, UTI, urinary retention) Systemic adverse events.


  7. Net change of the urge sensation [ Time Frame: Baseline and 3 months ]

    Efficacy:

    Net change of the urodynamic parameters: urge sensation from baseline to 3 months after the treatment day.

    Safety:

    Local adverse event incidences (hematuria, micturition pain, UTI, urinary retention) Systemic adverse events.


  8. Net change of the presence of detrusor overactivity [ Time Frame: Baseline and 3 months ]

    Efficacy:

    Net change of the urodynamic parameters: presence of detrusor overactivity from baseline to 3 months after the treatment day.

    Safety:

    Local adverse event incidences (hematuria, micturition pain, UTI, urinary retention) Systemic adverse events.


  9. Net change of the cystometric bladder capacity [ Time Frame: Baseline and 3 months ]

    Efficacy:

    Net change of the urodynamic parameters: cystometric bladder capacity from baseline to 3 months after the treatment day.

    Safety:

    Local adverse event incidences (hematuria, micturition pain, UTI, urinary retention) Systemic adverse events.


  10. Net change of the first sensation of detrusor pressure [ Time Frame: Baseline and 3 months ]

    Efficacy:

    Net change of the urodynamic parameters: detrusor pressure from baseline to 3 months after the treatment day.

    Safety:

    Local adverse event incidences (hematuria, micturition pain, UTI, urinary retention) Systemic adverse events.


  11. Net change of the first sensation of bladder compliance [ Time Frame: Baseline and 3 months ]

    Efficacy:

    Net change of the urodynamic parameters: bladder compliance from baseline to 3 months after the treatment day.

    Safety:

    Local adverse event incidences (hematuria, micturition pain, UTI, urinary retention) Systemic adverse events.


  12. Net change of the maximum flow rate [ Time Frame: Baseline and 3 months ]

    Efficacy:

    Net change of the urodynamic parameters: maximum flow rate from baseline to 3 months after the treatment day.

    Safety:

    Local adverse event incidences (hematuria, micturition pain, UTI, urinary retention) Systemic adverse events.


  13. Net change of the first sensation of voided volume [ Time Frame: Baseline and 3 months ]

    Efficacy:

    Net change of the urodynamic parameters: voided volume from baseline to 3 months after the treatment day.

    Safety:

    Local adverse event incidences (hematuria, micturition pain, UTI, urinary retention) Systemic adverse events.


  14. Net change of the postvoid residual volume [ Time Frame: Baseline and 3 months ]

    Efficacy:

    Net change of the urodynamic parameters: postvoid residual volume from baseline to 3 months after the treatment day.

    Safety:

    Local adverse event incidences (hematuria, micturition pain, UTI, urinary retention) Systemic adverse events.




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

Inclusion Criteria:

  • Adults with age of 20 years old or above
  • Patients with symptoms of urgency frequency and/or urge incontinence and urodynamically proven DHIC (defined by the ICS recommendation as: spontaneous detrusor contraction occurring during bladder filling phase or occurring before uninhibited detrusor contraction voiding at bladder capacity of less than 350ml in the urodynamic study, and has postvoid residual of more than 100ml but less than 250ml)
  • Free of active urinary tract infection
  • Free of bladder outlet obstruction on enrollment
  • Free of overt neurogenic bladder dysfunction
  • Having been treated with antimuscarinic agents for at least 1 months without effect or with intolerable adverse effects
  • Patient or his/her legally acceptable representative has signed the written informed consent form

Exclusion Criteria:

  • Use of antimuscarinic agent and effective in treatment of lower urinary tract symptoms
  • 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 postvoid residual > 250ml
  • Patients with uncontrolled confirmed diagnosis of acute urinary tract infection
  • 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

  • Patients with any contraindication to be urethral catheterization during treatment
  • Patients with any other serious disease considered by the investigator not in the condition to enter the trial
  • Patients participated investigational drug trial within 1 month before entering this study

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): NCT02135341


Locations
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Taiwan
Buddhist Tzu Chi General Hospital
Hualien, Taiwan, 970
Sponsors and Collaborators
Buddhist Tzu Chi General Hospital
Investigators
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Principal Investigator: Hann-Chorng Kuo, M.D. Department of Urology, Buddhist Tzu Chi General Hospital and Tzu Chi University
Publications:

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Responsible Party: Hann-Chorng Kuo, Director of Urology, Buddhist Tzu Chi General Hospital
ClinicalTrials.gov Identifier: NCT02135341    
Other Study ID Numbers: TCGHUROL010
First Posted: May 9, 2014    Key Record Dates
Last Update Posted: February 15, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: No IPD is planned to share
Keywords provided by Hann-Chorng Kuo, Buddhist Tzu Chi General Hospital:
Detrusor Overactivity
Impaired Contractility
Botulinum Toxin A (BoNT-A)
Additional relevant MeSH terms:
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Urinary Bladder, Overactive
Urinary Bladder Diseases
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Botulinum Toxins
Botulinum Toxins, Type A
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