Overactive Bladder
Conditions
Keywords
Frequency, urgency, incontinence
Brief summary
Demonstrate a response to stimulation of the posterior tibial nerve using the Biowave device and a microneedle patch electrode in patients with overactive bladder symptoms. The investigators hypothesize that after at least 6 weekly treatments there will be modest improvements in overactive bladder symptoms trending toward more improvement.
Detailed description
Women 18 years old and over with a score of equal to or greater than 4 on the OAB-q short form for urgency and average daily urinary frequency equal to or greater than 10 times based on a 3-day voiding diary plus other inclusion criteria will be reviewed for possible enrollment in this study. Outcomes measured include Global Response Assessment (GRA) for overall bladder symptoms, a change in the 3-day voiding diary parameters and adverse events.
Interventions
DEVICEBiowave Treatment
Twelve weekly treatments
Sponsors
Kenneth Peters, MD
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Women \>18 years of age * A score of \> 4 on the OAB-q short form for urgency (question 1) * Average daily urinary frequency \> 10 times based on a 3-day voiding diary * Self-reported bladder symptoms present \> 3 months * Self-reported failed conservative care (i.e., dietary restriction, fluid restriction, bladder training, behavioral modification, pelvic muscle training, biofeedback, etc.) * Off all antimuscarinics for at least 2 weeks prior to enrollment * Capable of giving informed consent * Ambulatory and able to use a toilet independently, without difficulty * Capable and willing to follow all study-related procedures
Exclusion criteria
* Pregnant as confirmed by urine pregnancy test, or plans to become pregnant during the study period * Neurogenic bladder * Botox® use in bladder or pelvic floor muscles in the past year * Pacemakers or implantable defibrillators * Primary complaint of stress urinary incontinence * Current urinary tract infection (UTI) * Current vaginal infection * Current use of InterStim® * Current use of Bion® * Previously been treated with Percutaneous Tibial Nerve Stimulation (PTNS) * Use of investigational drug/device therapy within the past 4 weeks. * Participating or have participated within the past 4 weeks in any clinical investigation involving or impacting gynecologic, urinary or renal function. * Deemed unsuitable for enrollment in study by the investigators based on subjects' history or physical examination (including skin disorders at the treatment site or peripheral neuropathy). * Subjects with nerve damage that would impact either percutaneous tibial nerve or pelvic floor function.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Global Response Assessment (GRA) | 3 months | The GRA will be used to assess for changes in urinary condition and symptoms after 12 weekly BIOWAVE treatments. The GRA asks the participant to indicate how their condition or symptoms have changed compared to when they started the study. Eight questions addressed bladder symptoms, urine leakage related to activity, urine leakage associated with urge, urinary frequency, Interstitial Cystitis/Painful Bladder Syndrome (IC/BPS), fecal incontinence, and irritable bowel syndrome. Responses range from 1=Markedly Worse to 7=Markedly Improved. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Biowave Treatment Twelve weekly treatments
Biowave Treatment: Twelve weekly treatments | 8 |
| Total | 8 |
Baseline characteristics
| Characteristic | Biowave Treatment |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 3 Participants |
| Age, Categorical Between 18 and 65 years | 5 Participants |
| Age, Continuous | 56.6 years |
| Region of Enrollment United States | 8 participants |
| Sex: Female, Male Female | 8 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 8 |
| serious Total, serious adverse events | 0 / 8 |
Outcome results
Primary
Global Response Assessment (GRA)
The GRA will be used to assess for changes in urinary condition and symptoms after 12 weekly BIOWAVE treatments. The GRA asks the participant to indicate how their condition or symptoms have changed compared to when they started the study. Eight questions addressed bladder symptoms, urine leakage related to activity, urine leakage associated with urge, urinary frequency, Interstitial Cystitis/Painful Bladder Syndrome (IC/BPS), fecal incontinence, and irritable bowel syndrome. Responses range from 1=Markedly Worse to 7=Markedly Improved.
Time frame: 3 months
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Biowave Treatment | Global Response Assessment (GRA) | Bladder Symptoms | 5.25 units on a scale |
| Biowave Treatment | Global Response Assessment (GRA) | Urine Leakage with Activity | 4 units on a scale |
| Biowave Treatment | Global Response Assessment (GRA) | Urge Incontinence | 4.6 units on a scale |
| Biowave Treatment | Global Response Assessment (GRA) | Urinary Frequency | 5.1 units on a scale |
| Biowave Treatment | Global Response Assessment (GRA) | Urinary Urge | 4.9 units on a scale |
| Biowave Treatment | Global Response Assessment (GRA) | IC/BPS | 4.3 units on a scale |
| Biowave Treatment | Global Response Assessment (GRA) | Fecal Incontinence | 4 units on a scale |
| Biowave Treatment | Global Response Assessment (GRA) | Irritable Bowel Symptoms | 4.25 units on a scale |