Clinical Trials Logo
  1. Home
  2. Urinary Incontinence
  3. NCT02601287
  4. Details
NCT02601287 Clinical Trial

A Safety and Efficacy Study of Botulinum Toxin Type A (BOTOX®) to Treat Urinary Incontinence Due to Neurogenic Detrusor Overactivity or Overactive Bladder in Korean Patients

Urinary Incontinence Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02601287
Other study ID # 191622-151
Secondary ID
Status Completed
Phase Phase 4
First received November 6, 2015
Last updated July 19, 2016
Start date November 2015
Est. completion date July 2016

Study information
Verified date July 2016
Source Allergan
Contact n/a
Is FDA regulated No
Health authority Korea: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

This is a safety and efficacy study of BOTOX® (Botulinum Toxin Type A) in the Treatment of Adult Korean Patients with Urinary Incontinence due to Neurogenic Detrusor Overactivity or Overactive Bladder.

Recruitment information / eligibility
Status Completed
Enrollment 168
Est. completion date July 2016
Est. primary completion date July 2016
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Urinary incontinence as a result of neurogenic overactive bladder due to spinal cord injury or multiple sclerosis

- Symptoms of urge urinary incontinence, urgency, and frequency due to overactive bladder

Exclusion Criteria:

- Myasthenia gravis, Eaton-Lambert syndrome, or amyotrophic lateral sclerosis

- Use of botulinum toxin therapy of any serotype in the 3 months prior to screening

- Has acute urinary retention who do not routinely perform clean intermittent self-catheterization (CIC)

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Biological:
• Botulinum Toxin Type A
Botulinum Toxin Type A into detrusor muscle on Day 1

Locations
Country Name City State
Korea, Republic of Pusan National University Hospital Busan Korea
Korea, Republic of The Catholic University of Korea Bucheion St. Mary Hospital Gyeonggi-do Korea
Korea, Republic of Asan Medical Center Seoul Korea
Korea, Republic of Samsung Medical Center Seoul Korea
Korea, Republic of Seoul National University Hospital Seoul Korea

Sponsors (1)
Lead Sponsor Collaborator
Allergan

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary Change from the baseline in the International Consultation on Incontinence Questionnaire Short Form (ICIQ-SF) total score Baseline, Day 28 No
See also
  Status Clinical Trial Phase
Recruiting NCT05534412 - A Practice-Based Intervention To Improve Care for a Diverse Population Of Women With Urinary Incontinence N/A
Recruiting NCT05515198 - Improving Care for Women With Urinary Incontinence (EMPOWER) N/A
Completed NCT04071301 - Collection of Real-life Measurement Data for TENA SmartCare Change Indicator in Subjects With Urinary Incontinence N/A
Completed NCT03623880 - Enhancing Behavioral Treatment for Women With Pelvic Floor Disorders N/A
Recruiting NCT05880862 - Comparative Effectiveness of Initial OAB Treatment Options Among Older Women at High Risk of Falls Early Phase 1
Recruiting NCT04159467 - Effect of Pelvic Floor Muscle Training on Urinary Incontinence Reports in Obese Women Undergoing a Low Calorie Diet N/A
Completed NCT05485922 - Performance of a Single-use Intermittent Micro-hole Zone Catheter N/A
Completed NCT06268782 - The Effectiveness of an Online Exercise Program on Well-being of Postpartum Women N/A
Not yet recruiting NCT03027986 - Evaluation of a Postural Rehabilitation Program Based on Sensory-motor Control in Men With Urinary Incontinence After Prostatectomy N/A
Recruiting NCT02490917 - ACT™ Balloons Versus Artificial Urinary Sphincter (AMS800™) for the Treatment of Female Stress Urinary Incontinence N/A
Enrolling by invitation NCT02529371 - Pre-Marketing Feasibility Evaluation of the UriCap-RM - Urine Collection in Hospitalized Male Patients N/A
Enrolling by invitation NCT02530372 - Feasibility of the UriCap-F for Urine Collection in Hospitalized Women N/A
Completed NCT02338726 - Pelvic Floor Symptoms and Quality of Life in Elderly Women - a Population-based Pilot Study N/A
Completed NCT02600676 - Transcutaneous Electric Nerve Stimulation (TENS) in Children With Enuresis N/A
Completed NCT02549729 - Effect of the Pelvic Floor Training in Postmenopausal Women With or Without Hormonal Therapy N/A
Completed NCT02239796 - Feasibility Controlled Trial of Tibial Nerve Stimulation for Stroke Related Urinary Incontinence N/A
Completed NCT02368262 - Prevalence of Incontinence and Risk Factors in Children With Cerebral Palsy N/A
Completed NCT01942681 - Female Patients With Signs of uRgE and Stress Urinary Incontinence Study of Propiverine Hydrochloride N/A
Recruiting NCT01804153 - Stem Cells Tratment for the Local Feminine Stress Urinary Incontinence Treatment (HULPURO) Phase 1/Phase 2
Completed NCT01520948 - Behavioral Therapy to Treat Urinary Symptoms in Parkinson Disease Phase 3