Urinary Incontinence
Conditions
Brief summary
The purpose of the study is to determine how effective Botox is in reducing the amount of urine leaked and which dose of Botox is more effective and safe in those who have urinary urge incontinence.
Detailed description
A multi-center clinical trial of Botulinum-A Toxin (Botox) for refractory urge incontinence.
Interventions
DRUGBotox
Injected
DRUGPlacebo
Injected
Sponsors
University of Rochester
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
21 Years to 90 Years
Healthy volunteers
Yes
Inclusion criteria
* Female subjects 21-90 years of age * subjects has urinary incontinence on 3 day bladder diary * subject has severe incontinence * urine dipstick or urine culture negative for urinary tract infection * cystometrogram without stress urinary leakage * must have failed at least one anti-cholinergic medication * negative urine pregnancy test on day of administration of study medication
Exclusion criteria
* history of carcinoma of the bladder * presence of foreign body in the bladder, cystitis or other correctable etiology for Urge Urinary Incontinance * gross fecal incontinence * known allergy to sulfa or ciprofloxacin or to lidocaine * any medical condition that may put the subject at increased risk with exposure to Botox * females who are pregnant, breast-feeding, or planning a pregnancy during the study or who are of child-bearing potential * known allergy to any of the components in the study medication * prior documented resistance to Botox * evidence of recent alcohol or drug abuse * concurrent participation in another investigational drug or device study within 30 days
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incontinent Episodes Per Day | week 13 | The number of incontinence episodes per day was recorded by each participant in a diary. All incontinence episodes were counted when calculating episodes per day at each time point. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Incontinence Pads Used Per Day | week 13 | The number of incontinence pads used per day per day was recorded by each participant in a diary. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Placebo Group 6 cc of saline was administered into the detrusor along the bladder base. We injected 0.5 ccs at each injection site. | 11 |
| Botox Group BTX was administered into the detrusor along the bladder base. BTX was reconstituted in 6 ccs of preservative free saline according to manufacturers instructions. We injected 0.5 ccs at each injection site. | 20 |
| Total | 31 |
Baseline characteristics
| Characteristic | Placebo Group | Botox Group | Total |
|---|---|---|---|
| Age, Continuous | 67.45 years STANDARD_DEVIATION 12.85 | 65.15 years STANDARD_DEVIATION 10.83 | 65.97 years STANDARD_DEVIATION 11.55 |
| Region of Enrollment United States | 11 participants | 20 participants | 31 participants |
| Sex: Female, Male Female | 11 Participants | 20 Participants | 31 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 3 / 11 | 11 / 20 |
| serious Total, serious adverse events | 0 / 11 | 0 / 20 |
Outcome results
Primary
Incontinent Episodes Per Day
The number of incontinence episodes per day was recorded by each participant in a diary. All incontinence episodes were counted when calculating episodes per day at each time point.
Time frame: week 13
| Arm | Measure | Value (GEOMETRIC_LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo Group | Incontinent Episodes Per Day | 7.34 incontinence episodes per day | Standard Error 1.07 |
| Botox Group | Incontinent Episodes Per Day | 3.90 incontinence episodes per day | Standard Error 0.75 |
p-value: <0.01ANOVA
Secondary
Number of Incontinence Pads Used Per Day
The number of incontinence pads used per day per day was recorded by each participant in a diary.
Time frame: week 13
| Arm | Measure | Value (GEOMETRIC_LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo Group | Number of Incontinence Pads Used Per Day | 5.18 pads per day | Standard Error 0.92 |
| Botox Group | Number of Incontinence Pads Used Per Day | 3.13 pads per day | Standard Error 0.66 |
p-value: <0.01ANOVA