Botulinum Toxin Urethral Sphincter Injection for Dysfunctional Voiding

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 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: June 25, 2014
Last verified: June 2014
  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:


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: 100
Study Start Date: October 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
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
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: 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: June 25, 2014
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 July 24, 2014