Overactive Bladder
Conditions
Keywords
OAB symptoms of urgency, frequency, and urge incontinence
Brief summary
The purpose of this study is to compare percutaneous tibial nerve stimulation (PTNS) to drug therapy for the treatment of symptoms of overactive bladder (OAB).
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).
DRUGTolterodine
Sponsors
Uroplasty, Inc
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Is at least 18 years of age * Experiences OAB with a voiding frequency of at least 8 times per day * Is ambulatory and able to use a toilet independently and without difficulty
Exclusion criteria
* On OAB pharmacotherapy within the previous month * Primary complaint is stress urinary incontinence * Has pacemaker or implantable defibrillator * Has history of heart problems * Has nerve damage or neuropathy * Has gastric or urinary retention * Has uncontrolled narrow-angle glaucoma * Has known sensitivity to drug ingredients * Is pregnant or planning to become pregnant during the trial
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Frequency of Voids at 12 Weeks | Baseline to 12 weeks | To demonstrate that the Urgent PC system is as effective as or more effective (noninferior) than tolterodine (Detrol LA) in changing the frequency of urinary voids per day after 12 weeks of therapy. The voiding diaries completed at 12 weeks were compared to the baseline voiding diaries. |
Secondary
| Measure | Time frame |
|---|---|
| Urge Incontinence Episodes at 12 Weeks | 12 weeks |
| Volume Voided at 12 Weeks | 12 weeks |
| OAB Quality of Life at 12 Weeks | 12 weeks |
| Known Side Effects Through 12 Weeks | 12 weeks |
Countries
United States
Participant flow
Recruitment details
Subjects were recruited by investigator sites with limited advertising
Pre-assignment details
After 12 weekly PTNS treatments, 35 patients were considered responders (reporting of Moderately or Markedly improved on the Global Response Assessment (GRA))and allowed to continue in the trial through 12 months.
Participants by arm
| Arm | Count |
|---|---|
| Urgent PC Treatment Arm 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). | 50 |
| 4mg Daily Tolterodine 90 day prescription for 4mg daily extended-release tolterodine tartrate (Detrol LA) | 50 |
| Total | 100 |
Baseline characteristics
| Characteristic | 4mg Daily Tolterodine | Urgent PC Treatment Arm | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 15 Participants | 17 Participants | 32 Participants |
| Age, Categorical Between 18 and 65 years | 35 Participants | 33 Participants | 68 Participants |
| Age Continuous | 58.2 years STANDARD_DEVIATION 11.3 | 57.5 years STANDARD_DEVIATION 15.2 | 57.85 years STANDARD_DEVIATION 13.25 |
| Region of Enrollment United States | 50 participants | 50 participants | 100 participants |
| Sex: Female, Male Female | 46 Participants | 48 Participants | 94 Participants |
| Sex: Female, Male Male | 4 Participants | 2 Participants | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 6 / 50 | 4 / 50 |
| serious Total, serious adverse events | 0 / 50 | 0 / 50 |
Outcome results
Primary
Frequency of Voids at 12 Weeks
To demonstrate that the Urgent PC system is as effective as or more effective (noninferior) than tolterodine (Detrol LA) in changing the frequency of urinary voids per day after 12 weeks of therapy. The voiding diaries completed at 12 weeks were compared to the baseline voiding diaries.
Time frame: Baseline to 12 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Urgent PC Treatment Arm | Frequency of Voids at 12 Weeks | -2.4 Voids/day | Standard Deviation 4 |
| 4mg Daily Tolterodine | Frequency of Voids at 12 Weeks | -2.5 Voids/day | Standard Deviation 3.9 |
Secondary
Known Side Effects Through 12 Weeks
Time frame: 12 weeks
Secondary
OAB Quality of Life at 12 Weeks
Time frame: 12 weeks
Secondary
Urge Incontinence Episodes at 12 Weeks
Time frame: 12 weeks
Secondary
Volume Voided at 12 Weeks
Time frame: 12 weeks