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Botulinum Toxin Urethral Sphincter Injection for Dysfunctional Voiding

This study is currently recruiting participants.
Verified November 2012 by Buddhist Tzu Chi General Hospital
Sponsor:
Information provided by (Responsible Party):
Hann-Chorng Kuo, Buddhist Tzu Chi General Hospital
ClinicalTrials.gov Identifier:
NCT01733290
First received: November 8, 2012
Last updated: November 20, 2012
Last verified: November 2012
History of Changes
  Purpose

This study is designed and aimed at determine the clinical efficacy of BoNT-A on patients with dysfunctional voiding. The results of this study can provide further information for patient selection and therapeutic duration.


Condition Intervention Phase
Dysfunctional Voiding
 Drug: Botulinum toxin A
Drug: Normal saline instillation
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Botulinum Toxin Urethral Sphincter Injection for Dysfunctional Voiding - A Multicenter Study, Randomized, Double-Blind, Placebo Control

Resource links provided by NLM:

U.S. FDA Resources

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

Primary Outcome Measures:
  • Net change of Patient Perception of Bladder Condition (PPBC) [ Time Frame: Baseline and 4 weeks ] [ Designated as safety issue: Yes ]

    Efficacy:

    Efficacy measured the net change of Patient Perception of Bladder Condition (PPBC) at baseline and 4 weeks after the initial injection. If patients have a PPBC improved by two scales, they are considered as successfully treated, otherwise failed treatment.

    Safety:

    Systemic adverse events



Secondary Outcome Measures:
  • Net change of the quality of life score [ Time Frame: Baseline and 4 weeks ] [ Designated as safety issue: Yes ]

    Efficacy:

    Efficacy measured the net change of the quality of life score at baseline and 4 weeks after BoNT-A injection within and between the treatment group and control groups. Quality of life score which are adopted from the International Prostate Symptom Score (IPSS) system.

    Safety:

    Systemic adverse events


  • Net change of the maximal urethral closure pressure (MUCP) [ Time Frame: Baseline and 4 weeks ] [ Designated as safety issue: Yes ]

    Efficacy:

    Efficacy measured the net change of the maximal urethral closure pressure (MUCP) at baseline and 4 weeks after BoNT-A injection within and between the treatment group and control groups.

    Safety:

    Systemic adverse events


  • Net change of the functional profile length (FPL) [ Time Frame: Baseline and 4 weeks ] [ Designated as safety issue: Yes ]

    Efficacy:

    Efficacy measured the net change of the functional profile length (FPL) at baseline and 4 weeks after BoNT-A injection within and between the treatment group and control groups.

    Safety:

    Systemic adverse events


  • Net change of the cystometric bladder capacity (CBC) [ Time Frame: Baseline and 4 weeks ] [ Designated as safety issue: Yes ]

    Efficacy:

    Efficacy measured the net change of cystometric bladder capacity (CBC) at baseline and 4 weeks after BoNT-A injection within and between the treatment group and control groups.

    Safety:

    Systemic adverse events


  • Net change of the bladder compliance [ Time Frame: Baseline and 4 weeks ] [ Designated as safety issue: Yes ]

    Efficacy:

    Efficacy measured the net change of the bladder compliance at baseline and 4 weeks after BoNT-A injection within and between the treatment group and control groups.

    Safety:

    Systemic adverse events


  • Net change of the voiding detrusor pressure (Pdet) [ Time Frame: Baseline and 4 weeks ] [ Designated as safety issue: Yes ]

    Efficacy:

    Efficacy measured the net change of the voiding detrusor pressure (Pdet) at baseline and 4 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 4 weeks ] [ Designated as safety issue: Yes ]

    Efficacy:

    Efficacy measured the net change of the maximal flow rate (Qmax) at baseline and 4 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 4 weeks ] [ Designated as safety issue: Yes ]

    Efficacy:

    Efficacy measured the net change of the voided volume at baseline and 4 weeks after BoNT-A injection within and between the treatment group and control groups.

    Safety:

    Systemic adverse events


  • Net change of the postvoid residual urine volume (PVR) [ Time Frame: Baseline and 4 weeks ] [ Designated as safety issue: Yes ]

    Efficacy:

    Efficacy measured the net change of the residual urine volume (PVR) at baseline and 4 weeks after BoNT-A injection within and between the treatment group and control groups.

    Safety:

    Systemic adverse events



Estimated Enrollment: 60
Study Start Date: October 2012
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Botulinum toxin A
A total of 100 units of BoNT-A will be injected deeply into the external sphincter at the 3, 6, 9 and 12 o'clock positions in approximate equal aliquot.
 Drug: Botulinum toxin A
A total of 100 units of BoNT-A will be injected deeply into the external sphincter at the 3, 6, 9 and 12 o'clock positions in approximate equal aliquot.
Other Name: Botulinum Toxin A (BoNT-A)
Placebo Comparator: Control arm-Normal saline instillation
Normal saline instillation
 Drug: Normal saline instillation
Normal saline instillation
Other Name: N/S

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   20 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adults with age of 20 years old or above.
  • Free of active urinary tract infection.
  • Free of bladder outlet obstruction on enrollment.
  • Patients should have severe dysuria or urinary retention, large residual urine and have been treated with medication or other therapeutic modality for over 3 months.

Exclusion Criteria:

  • 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 uncontrolled confirmed diagnosis of acute urinary tract infection.
  • Patients have laboratory abnormalities at screening including: Alanine aminotransferase (ALT) > 3 x upper limit of normal range aspartate aminotransferase (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.
  • Female patients who is pregnant, lactating, or with child-bearing potential without contraception.
  • Patients with any other serious disease considered by the investigator not suitable for general anesthesia or in the condition to enter the trial.
  • Patients participated investigational drug trial within 1 month before entering this study.
  • Written informed consent has been obtained.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01733290

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: Dong-Ling 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:
Nitti VW, Fiske J. Cystometrogram versus cystometrogram plus voiding pressure-flow studies in women with lower urinary tract symptoms. J Urol 161(Suppl):201,1999.
Kuo HC. Videourodynamic evaluation of the pathophysiology of lower urinary tract symptoms in neurologically intact women. Tzu Chi Med J 11:203-213,1999.

Responsible Party: Hann-Chorng Kuo, Director of Urology, Buddhist Tzu Chi General Hospital
ClinicalTrials.gov Identifier: NCT01733290     History of Changes
Other Study ID Numbers: TCGHUROL006
Study First Received: November 8, 2012
Last Updated: November 20, 2012
Health Authority: Taiwan: Department of Health
Taiwan: Research Ethics Committee

Keywords provided by Buddhist Tzu Chi General Hospital:
Botulinum Toxin A (BoNT-A)
Dysfunctional voiding

Additional relevant MeSH terms:
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 May 16, 2013