Trial Outcomes & Findings for Sham Controlled Trial of Rapid Induction Percutaneous Tibial Nerve Stimulation (NCT NCT03547518)
NCT ID: NCT03547518
Last Updated: 2023-08-14
Results Overview
Number of subjects reporting "Moderately" or "Markedly Improved" responses on the GRA after 3 interventions
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
25 participants
Primary outcome timeframe
One week post induction (+/- 3 days)
Results posted on
2023-08-14
Participant Flow
Recruitment was primarily through physician referrals from private urology clinics. Recruitment began in March 2018 and concluded in May 2022.
Participant milestones
| Measure |
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
|
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
|
|---|---|---|
|
Overall Study
STARTED
|
13
|
12
|
|
Overall Study
COMPLETED
|
11
|
12
|
|
Overall Study
NOT COMPLETED
|
2
|
0
|
Reasons for withdrawal
| Measure |
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
|
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
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
2
|
0
|
Baseline Characteristics
Sham Controlled Trial of Rapid Induction Percutaneous Tibial Nerve Stimulation
Baseline characteristics by cohort
| Measure |
Active PTNS Treatment
n=13 Participants
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
|
Sham Treatment
n=12 Participants
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
|
Total
n=25 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
13 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
9 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Age, Continuous
|
63.77 years
STANDARD_DEVIATION 10.08 • n=5 Participants
|
60.75 years
STANDARD_DEVIATION 8.01 • n=7 Participants
|
62.32 years
STANDARD_DEVIATION 9.09 • n=5 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
13 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
13 participants
n=5 Participants
|
12 participants
n=7 Participants
|
25 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: One week post induction (+/- 3 days)Population: One active treatment subject did not complete primary outcome
Number of subjects reporting "Moderately" or "Markedly Improved" responses on the GRA after 3 interventions
Outcome measures
| Measure |
Active PTNS Treatment
n=12 Participants
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
|
Sham Treatment
n=12 Participants
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
|
|---|---|---|
|
Improvement in GRA for Overall Bladder Symptoms
|
3 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Baseline and 1 week post induction (+/- 3 days)Population: 1 active treatment subject did not complete the 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.
Outcome measures
| Measure |
Active PTNS Treatment
n=12 Participants
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
|
Sham Treatment
n=12 Participants
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
|
|---|---|---|
|
Change From Baseline Urinary Frequency on 3 Day Voiding Diary
|
5 number of voids
Standard Deviation 6.21
|
1.08 number of voids
Standard Deviation 5.38
|
SECONDARY outcome
Timeframe: Baseline and one week post induction (+/- 3 days)Population: 1 active subject did not complete the 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.
Outcome measures
| Measure |
Active PTNS Treatment
n=12 Participants
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
|
Sham Treatment
n=12 Participants
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
|
|---|---|---|
|
Change From Baseline Nocturia in 3 Day Voiding Diary
|
-0.64 number of night time voids
Standard Deviation 2.11
|
0.31 number of night time voids
Standard Deviation 4.05
|
SECONDARY outcome
Timeframe: Baseline and 1 week post induction (+/- 3 days)Population: 1 active subject did not complete the 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.
Outcome measures
| Measure |
Active PTNS Treatment
n=12 Participants
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
|
Sham Treatment
n=12 Participants
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
|
|---|---|---|
|
Change From Baseline in Degree of Urgency in 3 Day Voiding Diary
|
4.82 number of voids recorded as urgent
Standard Deviation 9.42
|
-4.38 number of voids recorded as urgent
Standard Deviation 10.9
|
SECONDARY outcome
Timeframe: Baseline and one week post induction (+/- 3 days)Population: 1 active subject did not complete a 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.
Outcome measures
| Measure |
Active PTNS Treatment
n=12 Participants
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
|
Sham Treatment
n=12 Participants
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
|
|---|---|---|
|
Change From Baseline in Number of Urge Incontinence Episodes in 3 Day Voiding Diary
|
5 number of urge incontinence episodes
Standard Deviation 5.66
|
2 number of urge incontinence episodes
Standard Deviation 6.43
|
SECONDARY outcome
Timeframe: Baseline and 1 week post induction (+/- 3 days)Population: 1 active subject did not complete OABq at one week visit.
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.
Outcome measures
| Measure |
Active PTNS Treatment
n=12 Participants
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
|
Sham Treatment
n=12 Participants
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
|
|---|---|---|
|
Change From Baseline in Overactive Bladder Questionnaire-short Form Symptom Bother (OABq-SF)
|
17.73 score on a scale
Standard Deviation 18.41
|
18.97 score on a scale
Standard Deviation 14.68
|
Adverse Events
Active PTNS Treatment
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Sham Treatment
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Open Label Active PTNS Treatment
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Active PTNS Treatment
n=13 participants at risk
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
|
Sham Treatment
n=12 participants at risk
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
|
Open Label Active PTNS Treatment
n=12 participants at risk
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.
|
|---|---|---|---|
|
Cardiac disorders
Atypical Chest Pain
|
7.7%
1/13 • Number of events 1 • 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.
|
0.00%
0/12 • 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.
|
0.00%
0/12 • 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.
|
|
Respiratory, thoracic and mediastinal disorders
Asthmatic bronchitis
|
7.7%
1/13 • Number of events 1 • 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.
|
0.00%
0/12 • 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.
|
0.00%
0/12 • 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.
|
|
Infections and infestations
Urinary Tract Infection (UTI)
|
7.7%
1/13 • Number of events 1 • 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.
|
8.3%
1/12 • Number of events 1 • 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.
|
8.3%
1/12 • Number of events 1 • 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.
|
|
Skin and subcutaneous tissue disorders
Right lower extremity cellulitis
|
7.7%
1/13 • Number of events 1 • 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.
|
0.00%
0/12 • 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.
|
0.00%
0/12 • 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.
|
|
Musculoskeletal and connective tissue disorders
Right foot fracture
|
7.7%
1/13 • Number of events 1 • 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.
|
0.00%
0/12 • 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.
|
0.00%
0/12 • 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.
|
|
Renal and urinary disorders
Right renal cyst
|
7.7%
1/13 • Number of events 1 • 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.
|
0.00%
0/12 • 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.
|
0.00%
0/12 • 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.
|
|
Infections and infestations
COVID infection
|
0.00%
0/13 • 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.
|
8.3%
1/12 • Number of events 1 • 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.
|
16.7%
2/12 • Number of events 2 • 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.
|
|
Nervous system disorders
Right lower extremity tingling
|
0.00%
0/13 • 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.
|
0.00%
0/12 • 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.
|
8.3%
1/12 • Number of events 1 • 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.
|
Additional Information
Jennifer Giordano, RN BSN Clinical Research Manager
William Beaumont Hosptial
Phone: 248-551-3517
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place