Recruitment

Recruitment Status
Completed
Estimated Enrollment
18

Inclusion Criterias

Have screening laboratory values and electrocardiogram that are within the normal range
Detrusor overactivity with ≥1 uncontrolled phasic contraction(s) of the detrusor of at least 5 centimeters/H20 pressure documented on cystometry at Screening Visit 1A
Urinary urgency or nocturia
...
Have screening laboratory values and electrocardiogram that are within the normal range
Detrusor overactivity with ≥1 uncontrolled phasic contraction(s) of the detrusor of at least 5 centimeters/H20 pressure documented on cystometry at Screening Visit 1A
Urinary urgency or nocturia
Urge urinary incontinence five or more incontinence episodes per week
Able to understand study requirements (i.e., literate in English), give written informed consent, and comply with all study procedures and requirements.
Residual urine volume of ≤200 milliliters (ml)
Non-response or poor tolerance to previous treatment for symptoms of OAB/urinary incontinence and do not wish to continue these treatments
Frequent micturition ≥8 times per 24 hours
Healthy women of ≥18 years of age and non-childbearing potential

Exclusion Criterias

Latex allergy
Stress urinary incontinence as determined by observation of the participant coughing while standing with a full bladder and/or response of 2 or 3 on the following Stress Urinary Incontinence question: Do you experience leakage when laughing, coughing, lifting heavy objects or other types of discreet, moderately intense activities? 0=NONE: No leakage. 1=MILD: Minimal leakage on rare occasions during these types of activities; easily tolerated; do not use pads for this. 2=MODERATE: Enough leakage that it requires occasional use of pads and may interfere with usual activity and tasks. 3=SEVERE: Extreme leakage and discomfort that stops all activity and tasks and requires the use of pads on all occasions
Uncontrolled diabetes
...
Latex allergy
Stress urinary incontinence as determined by observation of the participant coughing while standing with a full bladder and/or response of 2 or 3 on the following Stress Urinary Incontinence question: Do you experience leakage when laughing, coughing, lifting heavy objects or other types of discreet, moderately intense activities? 0=NONE: No leakage. 1=MILD: Minimal leakage on rare occasions during these types of activities; easily tolerated; do not use pads for this. 2=MODERATE: Enough leakage that it requires occasional use of pads and may interfere with usual activity and tasks. 3=SEVERE: Extreme leakage and discomfort that stops all activity and tasks and requires the use of pads on all occasions
Uncontrolled diabetes
History of three or more culture-documented recurrent urinary tract infections per year
An indwelling urethral catheter or need for clean intermittent self-catheterization
Recent heart attack
Current history of Grade 2 or greater cystocele
Current history or previous diagnosis of painful bladder syndrome (interstitial cystitis) with pain in the region of the pelvis, perineum, or lower abdomen relieved by voiding
A life expectancy of less than 12 months
Current history of neurological bladder dysfunction
A woman with a positive serum (HCG) pregnancy test or who is lactating

Summary

Conditions
Overactive Bladder
Type
Interventional
Phase
Phase 1
Design
  • Allocation: Randomized
  • Intervention Model: Sequential Assignment
  • Intervention Model Description: sequential, dose escalationMasking: Triple (Participant, Investigator, Outcomes Assessor)
  • Primary Purpose: Other

Participation Requirements

Age
Between 18 years and 125 years
Gender
Only females

Description

This is a Phase 1 double-blind, placebo-controlled study assessing the safety and activity of 2 escalating doses of hMaxi-K gene transfer by direct injection into the bladder wall in female participants with OAB/DO. The safety parameters to be monitored include: adverse events, clinical laboratory t...

This is a Phase 1 double-blind, placebo-controlled study assessing the safety and activity of 2 escalating doses of hMaxi-K gene transfer by direct injection into the bladder wall in female participants with OAB/DO. The safety parameters to be monitored include: adverse events, clinical laboratory tests, electrocardiograms, and physical examinations. The secondary objective is to evaluate the efficacy of multiple intramuscular injections of hMaxi-K compared to the control group. Efficacy parameters that will be evaluated are: number of micturitions per 24 hours, volume per micturition, incontinence episodes, pad weight measurement of accidental bladder leaks, uninhibited contractions during cystoscopy and other cystoscopic evaluations, and general and bladder-specific quality of life assessments (Kings Health Questionnaire, SF-12 Health Survey, and International Consultation on Incontinence Questionnaire [ICIQ-SF]).

Inclusion Criterias

Have screening laboratory values and electrocardiogram that are within the normal range
Detrusor overactivity with ≥1 uncontrolled phasic contraction(s) of the detrusor of at least 5 centimeters/H20 pressure documented on cystometry at Screening Visit 1A
Urinary urgency or nocturia
...
Have screening laboratory values and electrocardiogram that are within the normal range
Detrusor overactivity with ≥1 uncontrolled phasic contraction(s) of the detrusor of at least 5 centimeters/H20 pressure documented on cystometry at Screening Visit 1A
Urinary urgency or nocturia
Urge urinary incontinence five or more incontinence episodes per week
Able to understand study requirements (i.e., literate in English), give written informed consent, and comply with all study procedures and requirements.
Residual urine volume of ≤200 milliliters (ml)
Non-response or poor tolerance to previous treatment for symptoms of OAB/urinary incontinence and do not wish to continue these treatments
Frequent micturition ≥8 times per 24 hours
Healthy women of ≥18 years of age and non-childbearing potential

Exclusion Criterias

Latex allergy
Stress urinary incontinence as determined by observation of the participant coughing while standing with a full bladder and/or response of 2 or 3 on the following Stress Urinary Incontinence question: Do you experience leakage when laughing, coughing, lifting heavy objects or other types of discreet, moderately intense activities? 0=NONE: No leakage. 1=MILD: Minimal leakage on rare occasions during these types of activities; easily tolerated; do not use pads for this. 2=MODERATE: Enough leakage that it requires occasional use of pads and may interfere with usual activity and tasks. 3=SEVERE: Extreme leakage and discomfort that stops all activity and tasks and requires the use of pads on all occasions
Uncontrolled diabetes
...
Latex allergy
Stress urinary incontinence as determined by observation of the participant coughing while standing with a full bladder and/or response of 2 or 3 on the following Stress Urinary Incontinence question: Do you experience leakage when laughing, coughing, lifting heavy objects or other types of discreet, moderately intense activities? 0=NONE: No leakage. 1=MILD: Minimal leakage on rare occasions during these types of activities; easily tolerated; do not use pads for this. 2=MODERATE: Enough leakage that it requires occasional use of pads and may interfere with usual activity and tasks. 3=SEVERE: Extreme leakage and discomfort that stops all activity and tasks and requires the use of pads on all occasions
Uncontrolled diabetes
History of three or more culture-documented recurrent urinary tract infections per year
An indwelling urethral catheter or need for clean intermittent self-catheterization
Recent heart attack
Current history of Grade 2 or greater cystocele
Current history or previous diagnosis of painful bladder syndrome (interstitial cystitis) with pain in the region of the pelvis, perineum, or lower abdomen relieved by voiding
A life expectancy of less than 12 months
Current history of neurological bladder dysfunction
A woman with a positive serum (HCG) pregnancy test or who is lactating

Locations

New York, New York, 10016
Garden City, New York, 11530
Poughkeepsie, New York, 12601
New York, New York, 10016
Garden City, New York, 11530
Poughkeepsie, New York, 12601

Tracking Information

NCT #
NCT01870037
Collaborators
Ion Channel Innovations
Investigators
Not Provided