Overactive Bladder
Conditions
Keywords
Overactive Bladder
Brief summary
The purpose of this study is to demonstrate superiority of percutaneous posterior tibial nerve stimulation (PTNS) therapy compared to sham therapy for the treatment of patients with overall bladder (OAB) symptoms.
Interventions
The Urgent PC Neuromodulation System is a minimally invasive neuromodulation system designed to deliver retrograde access to the sacral nerve through percutaneous electrical stimulation of the tibial nerve. The method of treatment is referred to as Percutaneous Tibial Nerve Stimulation (PTNS).
Sponsors
Uroplasty, Inc
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Women and men \>18 years of age * A score of \> 4 on the OAB-q short form for urgency (question 1) * Average urinary frequency \> 10 times in one 24 hour day 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 * Current use of TENS in the pelvic region, back or legs * Previously been treated with 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 bleeding disorders or anticoagulant medications, and peripheral neuropathy) * Subjects with nerve damage that would impact either percutaneous tibial nerve or pelvic floor function
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Global Response Assessment (GRA) for Overall Bladder Symptoms to Compare the Proportion of Subjects Reporting Moderately or Markedly Improved Responses on the GRA After 12 Interventions of Randomized Therapy, in an Intent to Treat Analysis. | 13 weeks | A responder was defined as reporting bladder symptoms as moderately or markedly improved on a 7-level GRA at week 13 after completing 12, 30-minute, consecutive weekly intervention sessions. |
Countries
United States
Participant flow
Recruitment details
Subjects were recruited by investigator sites with limited advertising
Participants by arm
| Arm | Count |
|---|---|
| Urgent PC | 110 |
| Sham / Placebo | 110 |
| Total | 220 |
Baseline characteristics
| Characteristic | Sham / Placebo | Urgent PC | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 46 Participants | 56 Participants | 102 Participants |
| Age, Categorical Between 18 and 65 years | 64 Participants | 54 Participants | 118 Participants |
| Age Continuous | 60.2 years STANDARD_DEVIATION 15.2 | 62.5 years STANDARD_DEVIATION 14.6 | 61.3 years STANDARD_DEVIATION 14.9 |
| Region of Enrollment United States | 110 participants | 110 participants | 220 participants |
| Sex: Female, Male Female | 88 Participants | 86 Participants | 174 Participants |
| Sex: Female, Male Male | 22 Participants | 24 Participants | 46 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 6 / 110 | 0 / 110 |
| serious Total, serious adverse events | 0 / 110 | 0 / 110 |
Outcome results
Primary
The Global Response Assessment (GRA) for Overall Bladder Symptoms to Compare the Proportion of Subjects Reporting Moderately or Markedly Improved Responses on the GRA After 12 Interventions of Randomized Therapy, in an Intent to Treat Analysis.
A responder was defined as reporting bladder symptoms as moderately or markedly improved on a 7-level GRA at week 13 after completing 12, 30-minute, consecutive weekly intervention sessions.
Time frame: 13 weeks
Population: Intent to treat
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Urgent PC | The Global Response Assessment (GRA) for Overall Bladder Symptoms to Compare the Proportion of Subjects Reporting Moderately or Markedly Improved Responses on the GRA After 12 Interventions of Randomized Therapy, in an Intent to Treat Analysis. | 60 participants |
| Sham / Placebo | The Global Response Assessment (GRA) for Overall Bladder Symptoms to Compare the Proportion of Subjects Reporting Moderately or Markedly Improved Responses on the GRA After 12 Interventions of Randomized Therapy, in an Intent to Treat Analysis. | 23 participants |
Comparison: Mean values were analyzed for significant change using a 2-sided paired t test and proportions were analyzed using chi-square methodology. Median values were analyzed using a Wilcoxon signed rank test with p\<0.05 considered statistically significant. A sample size estimate of 214 subjects, 107 per arm, was calculated using a 2-sided Fisher's exact binomial test based on an estimated 60% responder rate in the PTNS group and a 40% in the sham group with a 5% significance level and 80% power.p-value: 0.05t-test, 2 sided