Urinary Incontinence
Conditions
Brief summary
A multi-center, open-label, prospective, feasibility study evaluating the ParaPatch System for the treatment of urinary incontinence and overactive bladder.
Detailed description
* Baseline Period o The baseline period will allow for washout of any medication affecting bladder function and to allow subject to begin her voiding diary. * Prospective data collection will take place in the form voiding diary. Leak frequency, and other relevant parameters will be collected. * Inclusion/exclusion criteria will be rechecked at end of baseline. * Qol questionnaires will be completed in the office at the end of baseline period. * Evaluation Period o During the evaluation period, the subjects will use the ParaPatch System. * No medications affecting bladder function will be allowed during the evaluation period. * Subjects will complete voiding diaries, during the evaluation period. Data capture to include: adverse events, medication use, leak frequency and other relevant parameters. * Qol questionnaires will be completed in the office at the end of evaluation period. * Follow-up Period o Subjects will be followed for after the evaluation period to check for residual Adverse Events. * No medications affecting bladder function will be allowed during the follow-up period. * Subjects will be called by the clinical coordinator at the end of the Follow-up period and asked about potential Adverse Events.
Interventions
DEVICEParaPatch
A device for the treatment of urinary incontinence
Sponsors
ParaPatch, Inc
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 75 Years
Healthy volunteers
Yes
Inclusion criteria
* Women aged from \>18 to \< 75 years old. * Subject has the ability to read and comprehend English, and to reliably record information as required by the Protocol, including the proper completion of the questionnaires. * Subject is able to provide written informed consent prior to participation in the study. * Diagnosed with either of the following: a) overactive bladder, or b) urinary stress incontinence.
Exclusion criteria
* Are currently participating or have participated within the past 30 days in any clinical investigation involving or impacting urinary or renal function. * Subject has demonstrated or is believed to be at risk of non-compliance with study procedures (e.g., for completing the diary or returning for required follow-up visits). * Subject has undergone onabotulinumtoxin-A injections of the bladder in the last twelve (12) months. * Subject is not suitable for the study for any reason (including overall health, pre-existing conditions or medications) in the judgment of the investigator. * Have an untreated recurrent urinary tract infection (\> 2 times within the past 6 months). * Have neurogenic disorders such as Multiple Sclerosis, ALS, or Parkinson s Disease. * Patients with a diagnosis of painful bladder syndrome, other pelvic pain or interstitial cystitis.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Who Used the ParaPatch System With Adverse Events Through the Completion of the Study | up to 3 weeks | Documentation, follow-up and characterization of all adverse events in all subjects who use the ParaPatch System, through the completion of the study. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Stress Incontinence Arm | up to 3 weeks | Percentage of participants with less daily leaks from baseline to 3 weeks. |
| Overactive Bladder Arm | up to 3 weeks | Percentage of participants with less daily voids from baseline to 3 weeks. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 1) Stress Urinary Incontinence Stress urinary incontinence. Diagnosed with urinary stress incontinence and treated with the ParaPatch System
ParaPatch: A device for the treatment of urinary incontinence | 6 |
| 2) Overactive Bladder Overactive bladder. Diagnosed with overactive bladder syndrome and treated with the ParaPatch System
ParaPatch: A device for the treatment of urinary incontinence | 10 |
| Total | 16 |
Baseline characteristics
| Characteristic | 1) Stress Urinary Incontinence | 2) Overactive Bladder | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 2 Participants | 3 Participants | 5 Participants |
| Age, Categorical Between 18 and 65 years | 4 Participants | 7 Participants | 11 Participants |
| Sex/Gender, Customized Female | 6 participants | 10 participants | 16 participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 6 | 0 / 8 |
| serious Total, serious adverse events | 0 / 6 | 0 / 8 |
Outcome results
Primary
Number of Participants Who Used the ParaPatch System With Adverse Events Through the Completion of the Study
Documentation, follow-up and characterization of all adverse events in all subjects who use the ParaPatch System, through the completion of the study.
Time frame: up to 3 weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 1) Stress Urinary Incontinence | Number of Participants Who Used the ParaPatch System With Adverse Events Through the Completion of the Study | 8 participants |
| 2) Overactive Bladder | Number of Participants Who Used the ParaPatch System With Adverse Events Through the Completion of the Study | 6 participants |
Secondary
Overactive Bladder Arm
Percentage of participants with less daily voids from baseline to 3 weeks.
Time frame: up to 3 weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 1) Stress Urinary Incontinence | Overactive Bladder Arm | 83 percentage of participants |
| 2) Overactive Bladder | Overactive Bladder Arm | 75 percentage of participants |
Secondary
Stress Incontinence Arm
Percentage of participants with less daily leaks from baseline to 3 weeks.
Time frame: up to 3 weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 1) Stress Urinary Incontinence | Stress Incontinence Arm | 83 percentage of subjects |
| 2) Overactive Bladder | Stress Incontinence Arm | 75 percentage of subjects |