Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The aim of this study is to determine the efficacy of an accelerated course for percutaneous tibial nerve stimulation (PTNS) induction to treat overactive bladder symptoms. The standard 12 weekly induction treatments may be a patient burden and a more rapid induction may speed up symptomatic improvement.
Overactive bladder (OAB) is a common condition with a prevalence ranging from 5.9% to 16.9% in the United States and has been found to increase with age. OAB has a negative impact on health related quality of life (QoL), Per American Urological Association (AUA) / Society of Urodynamics, Female Pelvic Medicine and Urogenital Reconstruction (SUFU) guidelines, PTNS is a third line recommendation for OAB along with onabotulinumtoxinA (BTX) injection and sacral neuromodulation. In the single sham-controlled trial (SUmiT: n=220), Peters et al reported that 54.5% of PTNS subjects had moderately or markedly improved bladder symptoms on global response assessments (GRA) compared to 20.9% of sham subjects (p <0.001). PTNS subjects also had statistically significant improvements in frequency, nighttime voids, voids with moderate to severe urgency and urge urinary incontinence (UUI) episodes compared to sham. There is also early data from an implanted chronic tibial nerve stimulation lead study that shows a minimum of 8 hours of tibial nerve stimulation a day results in significant improvement in incontinence episodes per day at one week. Our study will test the concept of whether the PTNS effect is dose (total time of treatment) sensitive, and whether expanding the dosage of each treatment, i.e. from 30 minutes to 2 hours, will provide significant clinical improvement after a one week induction course.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active PTNS treatment | Experimental | One-week induction consisting of three active PTNS treatments, each 2 hours long |
|
| Sham treatment | Sham Comparator | One-week induction consisting of three sham treatments, each 2 hours long |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PTNS treatment | Device | One-week induction consisting of three active PTNS treatments, each 2 hours long |
|
| Measure | Description | Time Frame |
|---|---|---|
| Improvement in GRA for Overall Bladder Symptoms | Number of subjects reporting "Moderately" or "Markedly Improved" responses on the GRA after 3 interventions | One week post induction (+/- 3 days) |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline Urinary Frequency on 3 Day Voiding Diary | Change in number of total voids as measured by 3-day voiding diary, between pre-induction (baseline) and post-induction (post-treatment). Positive change means reduction in urinary frequency from baseline, negative change means increase in urinary frequency from baseline. | Baseline and 1 week post induction (+/- 3 days) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Note: For the sake of preserving scientific integrity, one or more of the eligibility criteria have been left off the list posted while the trial is ongoing. A full list of eligibility criteria will be posted upon completion of the trial.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Kenneth Peters, MD | Corewell Health East | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| William Beaumont Hospitals | Royal Oak | Michigan | 48073 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Recruitment was primarily through physician referrals from private urology clinics. Recruitment began in March 2018 and concluded in May 2022.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Active PTNS Treatment | One-week induction consisting of three active PTNS treatments, each 2 hours long PTNS treatment: One-week induction consisting of three active PTNS treatments, each 2 hours long |
| FG001 | Sham Treatment | One-week induction consisting of three sham treatments, each 2 hours long Sham treatment: One-week induction consisting of three active PTNS treatments, each 2 hours long |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Active PTNS Treatment | One-week induction consisting of three active PTNS treatments, each 2 hours long PTNS treatment: One-week induction consisting of three active PTNS treatments, each 2 hours long |
| BG001 | Sham Treatment |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Improvement in GRA for Overall Bladder Symptoms | Number of subjects reporting "Moderately" or "Markedly Improved" responses on the GRA after 3 interventions | One active treatment subject did not complete primary outcome | Posted | Count of Participants | Participants | One week post induction (+/- 3 days) |
|
Adverse events were collected for 12 weeks in active treatment group and sham treatment groups. Sham patients that continued to the open label active PTNS treatment phase were monitored for 12 weeks.
Adverse events were collected at each visit by asking the participant if there were any changes to their medical history, hospitalizations, or new acute conditions.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Active PTNS Treatment | One-week induction consisting of three active PTNS treatments, each 2 hours long PTNS treatment: One-week induction consisting of three active PTNS treatments, each 2 hours long |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Atypical Chest Pain | Cardiac disorders | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jennifer Giordano, RN BSN Clinical Research Manager | William Beaumont Hosptial | 248-551-3517 | jennifer.giordano@corewellhealth.org |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 21, 2020 | May 16, 2023 | Prot_SAP_000.pdf |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D053201 | Urinary Bladder, Overactive |
| D053202 | Urinary Incontinence, Urge |
| ID | Term |
|---|---|
| D001745 | Urinary Bladder Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
Not provided
Not provided
Randomized, single blind parallel assignment
Not provided
Not provided
Participant blinded to interventional or sham treatment
| Sham treatment | Device | One-week induction consisting of three active PTNS treatments, each 2 hours long |
|
|
| Change From Baseline Nocturia in 3 Day Voiding Diary | Change in number of total night time urinary voids over three days as measured by 3-day voiding diary, between pre-induction (baseline) and post-induction (post-treatment). Positive change means reduction in number of night time voids. Negative change means increase in number of night time voids. | Baseline and one week post induction (+/- 3 days) |
| Change From Baseline in Degree of Urgency in 3 Day Voiding Diary | Change in number of urinary voids recorded as urgent over three days as measured by 3-day voiding diary, between pre-induction (baseline) and post-induction (end of treatment). Positive change means reduction in urge incontinence episodes. Negative change means increase in urge incontinence episodes. | Baseline and 1 week post induction (+/- 3 days) |
| Change From Baseline in Number of Urge Incontinence Episodes in 3 Day Voiding Diary | Change in number of urge incontinence episodes over three days as measured by 3-day voiding diary, between pre-induction (baseline) and post-induction (post-treatment). Positive change means reduction in urge incontinence episodes. Negative change means increase in urge incontinence episodes. | Baseline and one week post induction (+/- 3 days) |
| Change From Baseline in Overactive Bladder Questionnaire-short Form Symptom Bother (OABq-SF) | Change from baseline in total score on a 6 question survey of extent of how much patients were bothered by bladder symptoms, with each question rated on a 6 point likert scale with 1= Not at all and 6= a very great deal. Score range 0-100. Higher score equals worse overactive bladder symptoms. Positive change means improvement in OAB symptoms. Negative change means worsening of OAB symptoms. | Baseline and 1 week post induction (+/- 3 days) |
One-week induction consisting of three sham treatments, each 2 hours long
Sham treatment: One-week induction consisting of three active PTNS treatments, each 2 hours long
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Secondary | Change From Baseline Urinary Frequency on 3 Day Voiding Diary | Change in number of total voids as measured by 3-day voiding diary, between pre-induction (baseline) and post-induction (post-treatment). Positive change means reduction in urinary frequency from baseline, negative change means increase in urinary frequency from baseline. | 1 active treatment subject did not complete the diary. | Posted | Mean | Standard Deviation | number of voids | Baseline and 1 week post induction (+/- 3 days) |
|
|
|
|
| Secondary | Change From Baseline Nocturia in 3 Day Voiding Diary | Change in number of total night time urinary voids over three days as measured by 3-day voiding diary, between pre-induction (baseline) and post-induction (post-treatment). Positive change means reduction in number of night time voids. Negative change means increase in number of night time voids. | 1 active subject did not complete the diary | Posted | Mean | Standard Deviation | number of night time voids | Baseline and one week post induction (+/- 3 days) |
|
|
|
|
| Secondary | Change From Baseline in Degree of Urgency in 3 Day Voiding Diary | Change in number of urinary voids recorded as urgent over three days as measured by 3-day voiding diary, between pre-induction (baseline) and post-induction (end of treatment). Positive change means reduction in urge incontinence episodes. Negative change means increase in urge incontinence episodes. | 1 active subject did not complete the diary | Posted | Mean | Standard Deviation | number of voids recorded as urgent | Baseline and 1 week post induction (+/- 3 days) |
|
|
|
|
| Secondary | Change From Baseline in Number of Urge Incontinence Episodes in 3 Day Voiding Diary | Change in number of urge incontinence episodes over three days as measured by 3-day voiding diary, between pre-induction (baseline) and post-induction (post-treatment). Positive change means reduction in urge incontinence episodes. Negative change means increase in urge incontinence episodes. | 1 active subject did not complete a diary | Posted | Mean | Standard Deviation | number of urge incontinence episodes | Baseline and one week post induction (+/- 3 days) |
|
|
|
|
| Secondary | Change From Baseline in Overactive Bladder Questionnaire-short Form Symptom Bother (OABq-SF) | Change from baseline in total score on a 6 question survey of extent of how much patients were bothered by bladder symptoms, with each question rated on a 6 point likert scale with 1= Not at all and 6= a very great deal. Score range 0-100. Higher score equals worse overactive bladder symptoms. Positive change means improvement in OAB symptoms. Negative change means worsening of OAB symptoms. | 1 active subject did not complete OABq at one week visit. | Posted | Mean | Standard Deviation | score on a scale | Baseline and 1 week post induction (+/- 3 days) |
|
|
|
|
| 0 |
| 13 |
| 0 |
| 13 |
| 6 |
| 13 |
| EG001 | Sham Treatment | One-week induction consisting of three sham treatments, each 2 hours long Sham treatment: One-week induction consisting of three active PTNS treatments, each 2 hours long | 0 | 12 | 0 | 12 | 2 | 12 |
| EG002 | Open Label Active PTNS Treatment | Sham participants that continued to the open label active PTNS treatment phase. One- week induction consisting of three active PTNS treatments, each 2 hours long. | 0 | 12 | 0 | 12 | 3 | 12 |
| Asthmatic bronchitis | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Urinary Tract Infection (UTI) | Infections and infestations | Systematic Assessment |
|
| Right lower extremity cellulitis | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Right foot fracture | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Right renal cyst | Renal and urinary disorders | Systematic Assessment |
|
| COVID infection | Infections and infestations | Systematic Assessment |
|
| Right lower extremity tingling | Nervous system disorders | Systematic Assessment |
|
Not provided
Not provided
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D059411 | Lower Urinary Tract Symptoms |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D014549 | Urinary Incontinence |
| D014555 | Urination Disorders |