Urinary Bladder, Overactive
Conditions
Keywords
Urgent PC, Overactive Bladder, SUmiT Trial, Overactive Urinary Bladder
Brief summary
This is a modified extension study to the SUmiT protocol UPC082008 (NCT00534521) to observe and evaluate long term therapy with PTNS on overactive bladder symptoms. Subjects must have completed the 12 weekly treatments of the original protocol, the 13 week follow up assessment, be randomized to the PTNS arm, and be considered a positive responder with moderate or marked improvement in the SUmiT Trial to be enrolled in this study. All consenting responders will continue with active PTNS therapy at an initially prescribed protocol for approximately 3 months followed by individualized symptom-based frequency of visits as determined by the subject along with their treating clinician, for up to a total of 33 months post initial 12-week therapy for a total of 3 years.
Interventions
DEVICEUrgent PC
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
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Subjects who signed the informed consent and were eligible to participate in the original SUmiT Trial * Subjects who were randomized and treated with the active PTNS therapy during their participation in the original SUmiT Trial * Subject must be a positive responder from initial 12 weekly treatments as prescribed in original SUmiT Trial - 13 week GRA questionnaire must indicate moderately or markedly improved on question #1 of GRA * Subjects must not have started any antimuscarinics treatment since completion of original SUmiT Trial * Subjects must not have started any urologic Botox treatment since completion of original SUmiT Trial * Subjects must remain off all antimuscarinics throughout participation in trial * Subjects must initiate PTNS maintenance therapy within 2 weeks of their last PTNS treatment as part of SUmiT protocol UPC082008 * Capable of giving informed consent * Capable and willing to follow all study-related procedures for up to 33 months for a total participation of 3 years
Exclusion criteria
* Pregnant as confirmed by urine pregnancy test, or plans to become pregnant during the study period * Subjects who were not able or willing to follow original SUmiT Trial study schedule
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Patients Reporting Moderately or Markedly Improved on the Global Response Assessment (GRA) at 36 Months as Compared to Baseline | 36 months total | The GRA asked patients, Compared to the last time you completed this questionnaire, how would you rate your bladder symptoms now? and was a 7-level Assessment (markedly improved, moderately improved, slightly improved, no change, slightly worse, moderately worse, markedly worse). |
Secondary
| Measure | Time frame |
|---|---|
| GRA Subset of Individual Bladder Symptom Components to Include Urgency, Frequency and Urge Incontinence. | every three months for 36 months |
| Change in OAB-q and SF-36 Questionnaires. | every three months for 36 months |
| Change in Voiding Diary Parameters. | every three months for 36 months |
Countries
United States
Participant flow
Recruitment details
Subjects were recruited by investigator sites.
Participants by arm
| Arm | Count |
|---|---|
| Urgent PC 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 |
| Total | 50 |
Baseline characteristics
| Characteristic | Urgent PC |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 24 Participants |
| Age, Categorical Between 18 and 65 years | 26 Participants |
| Age Continuous | 60.5 years STANDARD_DEVIATION 15.5 |
| Region of Enrollment United States | 50 participants |
| Sex: Female, Male Female | 39 Participants |
| Sex: Female, Male Male | 11 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 1 / 50 |
| serious Total, serious adverse events | 0 / 50 |
Outcome results
Primary
Proportion of Patients Reporting Moderately or Markedly Improved on the Global Response Assessment (GRA) at 36 Months as Compared to Baseline
The GRA asked patients, Compared to the last time you completed this questionnaire, how would you rate your bladder symptoms now? and was a 7-level Assessment (markedly improved, moderately improved, slightly improved, no change, slightly worse, moderately worse, markedly worse).
Time frame: 36 months total
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Urgent PC | Proportion of Patients Reporting Moderately or Markedly Improved on the Global Response Assessment (GRA) at 36 Months as Compared to Baseline | .77 Proportion of Patients |
Secondary
Change in OAB-q and SF-36 Questionnaires.
Time frame: every three months for 36 months
Secondary
Change in Voiding Diary Parameters.
Time frame: every three months for 36 months
Secondary
GRA Subset of Individual Bladder Symptom Components to Include Urgency, Frequency and Urge Incontinence.
Time frame: every three months for 36 months