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

NCT02135341 | Completed Phase 2

• 1 other identifier: TCGHUROL010
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Conditions

Botulinum Toxins, Type A

Keywords

Detrusor Overactivity; Impaired Contractility; Botulinum Toxin A (BoNT-A)

Outcome Measures

Primary Outcomes (1)

• Net change of the Patients Perception of Bladder Condition (PPBC)

  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

  Baseline and 3 months

Secondary Outcomes (14)

• Net change of the International Prostate Symptom Score (IPSS)

  Baseline and 3 months

• Net change of the bladder capacity

  Baseline and 3 months

• Net change of the voiding frequency at daytime

  Baseline and 3 months

• Net change of the voiding frequency at night time

  Baseline and 3 months

• Net change of voiding urgency severity score

  Baseline and 3 months

Study Arms (2)

Group A: Botulinum toxin A

EXPERIMENTAL

BoNT-A 100 units in normal saline 10ml, suburothelial injection at 20 sites of bladder wall in single treatment

Drug: Botulinum toxin A

Group B: Botulinum toxin A

EXPERIMENTAL

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

Interventions

Botulinum toxin A DRUG

BoNT-A 100 units in normal saline 10ml, suburothelial injection at 20 sites of bladder wall in single treatment

Also known as: BoNT-A, BOTOX (Allergan, Irvine, CA, USA)

Group A: Botulinum toxin A

Eligibility Criteria

• Age: 20 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Buddhist Tzu Chi General Hospital: lead

Study Sites (1)

Buddhist Tzu Chi General Hospital

Hualien City, 970, Taiwan

Location

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MeSH Terms

Conditions

Urinary Bladder, Overactive

Interventions

Botulinum Toxins, Type A; incobotulinumtoxinA

Condition Hierarchy (Ancestors)

Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Botulinum Toxins; Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Bacterial Toxins; Toxins, Biological; Biological Factors

Study Officials

• Hann-Chorng Kuo, M.D.

  Department of Urology, Buddhist Tzu Chi General Hospital and Tzu Chi University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Masking Details: No masking was designed in this study
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Urology

Model Details: 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

Study Record Dates

• First Submitted: May 8, 2014
• First Posted: May 9, 2014
• Study Start: May 1, 2014
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: February 15, 2017

Record last verified: 2017-02

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)