Botulinum Toxin Urethral Sphincter Injection for Dysfunctional Voiding

NCT01733290 | Completed Phase 2

• 1 other identifier: TCGHUROL006
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Dysfunctional Voiding

Keywords

Botulinum Toxin A (BoNT-A); Dysfunctional voiding

Outcome Measures

Primary Outcomes (1)

• Net change of Patient Perception of Bladder Condition (PPBC)

  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

  Baseline and 4 weeks

Secondary Outcomes (9)

• Net change of the quality of life score

  Baseline and 4 weeks

• Net change of the maximal urethral closure pressure (MUCP)

  Baseline and 4 weeks

• Net change of the functional profile length (FPL)

  Baseline and 4 weeks

• Net change of the cystometric bladder capacity (CBC)

  Baseline and 4 weeks

• Net change of the bladder compliance

  Baseline and 4 weeks

Study Arms (2)

Botulinum toxin A

EXPERIMENTAL

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

Control arm-Normal saline instillation

PLACEBO COMPARATOR

Normal saline instillation

Drug: Normal saline instillation

Interventions

Botulinum toxin A DRUG

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.

Also known as: Botulinum Toxin A (BoNT-A)

Botulinum toxin A

Normal saline instillation DRUG

Normal saline instillation

Also known as: N/S

Control arm-Normal saline instillation

Eligibility Criteria

• Age: 20 Years - 65 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.
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Buddhist Tzu Chi General Hospital: lead

Study Sites (1)

Buddhist Tzu Chi General Hospital

Hualien City, 970, Taiwan

Location

Related Publications (28)

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MeSH Terms

Interventions

Botulinum Toxins, Type A; incobotulinumtoxinA

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: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Urology

Study Record Dates

• First Submitted: November 8, 2012
• First Posted: November 27, 2012
• Study Start: October 1, 2012
• Primary Completion: February 1, 2017
• Study Completion: February 1, 2017
• Last Updated: March 8, 2017

Record last verified: 2017-03

Locations

TW (1)