Effects and Safety of Liposome Encapsulated Botulinum Toxin A for Overactive Bladder Syndrome

NCT01167257 | Completed Phase 2 Results

• 1 other identifier: TCGHUROL001
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

Brief Summary

Overactive bladder (OAB) is a bothered symptom syndrome. Traditional medication for OAB is antimuscarinic agent. However, adverse events such as dry mouth, constipation, blurred vision, and dizziness may prohibit patient to take this drug for OAB. Intravesical botulinum toxin A (BoNT-A) is a novel treatment however, BoNT-A can cause acute urinary retention and large postvoid residual. In this grant we will evaluate liquid liposome delivery of BoNT-A (Liposome encapsulated BoNT-A) into the bladder without the need for cystoscopic-guided needle injection for refractory OAB.

Conditions

Overactive Bladder

Keywords

Overactive bladder; Detrusor overactivity; Liposome; Botulinum toxin A

Outcome Measures

Primary Outcomes (1)

• Mean Change of the Total Frequency Per 3 Days

  Efficacy: Mean change of the total frequency per 3 days from baseline to 4 weeks after the treatment day based on the 3-day voiding diary. Change = Week 4 minus Baseline value

  Baseline to 4 weeks after initial treatment

Secondary Outcomes (8)

• Mean Change of the Urgency Episodes Per 3 Days

  Baseline to 4 weeks after initial treatment

• Mean Change of the Urgency Urinary Incontinence (UUI) Per 3 Days

  Baseline to 4 weeks after initial treatment

• Net Change of the Overactive Bladder Symptom Score (OABSS)

  Baseline to 4 weeks after initial treatment

• Net Change of the Functional Bladder Capacity (FBC)

  Baseline to 4 weeks after initial treatment

• Net Change of the Maximum Flow Rate (Qmax)

  Baseline to 4 weeks after initial treatment

Study Arms (2)

Experimental arm

EXPERIMENTAL

Liposome encapsulated BoNT-A ( mixed BOTOX 200 U/10 mL in Liposome 80 mg/40 mL) in single intravesical instillation Liposome encapsulated botulinum toxin A'

Drug: Liposome encapsulated botulinum toxin A

Control arm

PLACEBO COMPARATOR

Normal saline 50 mL in single intravesical instillation Normal saline instillation'

Drug: Normal saline instillation

Interventions

Liposome encapsulated botulinum toxin A DRUG

Liposome encapsulated BoNT-A ( mixed BOTOX 200 U/10 mL water in Liposome 80 mg/40 mL water) in single intravesical instillation, one time treatment at the treatment day

Also known as: Lipotoxin

Experimental arm

Normal saline instillation DRUG

Normal saline (BoNT-A/NS) 50 mL in single intravesical instillation

Also known as: N/S

Control arm

Eligibility Criteria

• Age: 18 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 a urgency severity scale (USS) of at least 2, with or without urodynamically proven detrusor overactivity (DO) (defined by the International Continence Society (ICS) recommendation as: spontaneous detrusor contraction occurring during bladder filling phase or occurring before uninhibited detrusor contraction voiding at bladder capacity in the urodynamic study)
• 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 4 weeks without effect or with intolerable adverse effects
• Patient has not been treated with bladder surgery for OAB, such as enterocystoplasty, that might affect the therapeutic effect of test drug
• Patient can record voiding diary for the urinary frequency and urgency
• 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 \>150 mL
• 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.
• Myasthenia gravis, Eaton Lambert syndrome.
• 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

Sponsors & Collaborators

• Buddhist Tzu Chi General Hospital: lead

Study Sites (1)

Buddhist Tzu Chi General Hospital

Hualien City, 970, Taiwan

Location

MeSH Terms

Conditions

Urinary Bladder, Overactive

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

Results Point of Contact

• Title: Dr. Hann-Chorng Kuo
• Organization: Department of Urology, Buddhist Tzu Chi General Hospital and Tzu Chi University

hck@tzuchi.com.tw

886-3-8561825

Study Officials

• Hann-Chorng Kuo, M.D.

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

  PRINCIPAL INVESTIGATOR

• Yao-Chi Chuang, M.D.

  Department of Urology, Chang Gung Memorial Hospital, Kaohsiung, Taiwan

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

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: Department of Urology

Study Record Dates

• First Submitted: July 20, 2010
• First Posted: July 22, 2010
• Study Start: May 1, 2010
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: September 22, 2014
• Results First Posted: September 22, 2014

Record last verified: 2014-09

Locations

TW (1)