Trial Outcomes & Findings for Effectiveness of Bilateral PTNS Compared to Unilateral PTNS for the Treatment of Overactive Bladder/Urge Incontinence (NCT NCT03535857)
NCT ID: NCT03535857
Last Updated: 2025-04-15
Results Overview
Overactive Bladder questionnaire short form (OABqSF) symptom severity questionnaire was administered at baseline, 4 weeks, 8 weeks then 12 weeks. The OABqSF score ranges from 0 to 100. Those with more bothersome symptoms have higher scores. The investigators expected more improvement in symptoms from participants receiving bilateral stimulation compared to those with unilateral stimulation.
TERMINATED
NA
36 participants
12 weeks or last measurement
2025-04-15
Participant Flow
Participant milestones
| Measure |
Unilateral PTNS
34 gauge needle inserted 3cm above the medial ankle on the ankle, and cables are connected to the PTNS stimulator device. Stimulation is provided, per manufacturer directions, over a 30-minute treatment period
PTNS: Use of PTNS on the ankle for 30 minutes
|
Bilateral PTNS
34 gauge needle inserted 3cm above the medial ankle on both ankles, and cables are connected to the PTNS stimulator device. Stimulation is provided, per manufacturer directions, over a 30-minute treatment period
PTNS: Use of PTNS on the ankle for 30 minutes
|
|---|---|---|
|
Overall Study
STARTED
|
18
|
18
|
|
Overall Study
COMPLETED
|
13
|
16
|
|
Overall Study
NOT COMPLETED
|
5
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Unilateral PTNS
n=18 Participants
PTNS: Use of PTNS on the ankle for 30 minutes
|
Bilateral PTNS
n=18 Participants
PTNS: Use of PTNS on both ankles for 30 minutes
|
Total
n=36 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
Age
|
68.1 years
STANDARD_DEVIATION 13.8 • n=18 Participants
|
69.4 years
STANDARD_DEVIATION 11.4 • n=18 Participants
|
68.7 years
STANDARD_DEVIATION 12.5 • n=36 Participants
|
|
Sex: Female, Male
Female
|
18 Participants
n=18 Participants
|
18 Participants
n=18 Participants
|
36 Participants
n=36 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=18 Participants
|
0 Participants
n=18 Participants
|
0 Participants
n=36 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
On Overactive bladder (OAB) Medications
|
6 participants
n=18 Participants
|
4 participants
n=18 Participants
|
10 participants
n=36 Participants
|
|
History of Diabetes mellitus
|
2 participants
n=18 Participants
|
7 participants
n=18 Participants
|
9 participants
n=36 Participants
|
|
Overactive bladder questionnaire short form (OABq SF) Score
|
64.6 units on a scale
STANDARD_DEVIATION 21.6 • n=17 Participants • Missing data
|
56.1 units on a scale
STANDARD_DEVIATION 26.2 • n=18 Participants • Missing data
|
60.4 units on a scale
STANDARD_DEVIATION 24.1 • n=35 Participants • Missing data
|
|
Incontinence Impact Questionnaire (IIQ) Score
|
49.5 units on a scale
STANDARD_DEVIATION 29.7 • n=17 Participants • Missing data
|
59.8 units on a scale
STANDARD_DEVIATION 23.6 • n=18 Participants • Missing data
|
54.8 units on a scale
STANDARD_DEVIATION 26.9 • n=35 Participants • Missing data
|
|
Daily Incontinence Episodes
|
2.3 Incontinence episodes
STANDARD_DEVIATION 2.4 • n=16 Participants • Missing data
|
2.6 Incontinence episodes
STANDARD_DEVIATION 2.0 • n=17 Participants • Missing data
|
2.5 Incontinence episodes
STANDARD_DEVIATION 2.2 • n=33 Participants • Missing data
|
|
Nocturia Episodes
|
1.7 Nocturia episodes
STANDARD_DEVIATION 1.4 • n=8 Participants • Missing data
|
1.7 Nocturia episodes
STANDARD_DEVIATION 1.9 • n=9 Participants • Missing data
|
1.7 Nocturia episodes
STANDARD_DEVIATION 1.6 • n=17 Participants • Missing data
|
|
Daily voids
|
9.8 Daily voids
STANDARD_DEVIATION 3.2 • n=16 Participants • Missing data
|
9.6 Daily voids
STANDARD_DEVIATION 4.1 • n=17 Participants • Missing data
|
9.7 Daily voids
STANDARD_DEVIATION 3.7 • n=33 Participants • Missing data
|
PRIMARY outcome
Timeframe: 12 weeks or last measurementPopulation: Analysis was performed on all enrolled participants data available even if the participant withdrew from study prior to completion of study.
Overactive Bladder questionnaire short form (OABqSF) symptom severity questionnaire was administered at baseline, 4 weeks, 8 weeks then 12 weeks. The OABqSF score ranges from 0 to 100. Those with more bothersome symptoms have higher scores. The investigators expected more improvement in symptoms from participants receiving bilateral stimulation compared to those with unilateral stimulation.
Outcome measures
| Measure |
Unilateral PTNS Change in Overactive Bladder Questionnaire Short Form Score
n=17 Participants
Change in overactive bladder symptom severity was measured by comparing last overactive bladder questionnaire score to overactive bladder questionnaire score at baseline for one ankle stimulation
|
Bilateral PTNS Change in Overactive Bladder Questionnaire Short Form Score
n=17 Participants
Change in overactive bladder symptom severity was measured by comparing last overactive bladder questionnaire score to overactive bladder questionnaire score at baseline for two ankle stimulation
|
|---|---|---|
|
Change in Overactive Bladder Questionnaire Score From Baseline to 12 Weeks or Last Measurement
|
-17.8 score on a scale
Standard Deviation 24.7
|
-23.5 score on a scale
Standard Deviation 29.3
|
SECONDARY outcome
Timeframe: 12 weeks or last measurementPopulation: Analysis was performed on all enrolled participants data available even if the participant withdrew from study prior to completion of study.
The change in number of voids was obtained by comparing number of voids at 12 weeks or last measurement compared to baseline number of voids.
Outcome measures
| Measure |
Unilateral PTNS Change in Overactive Bladder Questionnaire Short Form Score
n=16 Participants
Change in overactive bladder symptom severity was measured by comparing last overactive bladder questionnaire score to overactive bladder questionnaire score at baseline for one ankle stimulation
|
Bilateral PTNS Change in Overactive Bladder Questionnaire Short Form Score
n=17 Participants
Change in overactive bladder symptom severity was measured by comparing last overactive bladder questionnaire score to overactive bladder questionnaire score at baseline for two ankle stimulation
|
|---|---|---|
|
Change in Daily Number of Voids From Baseline to 12 Weeks or Last Measurement
|
-0.2 Number of daytime voids
Standard Deviation 3.3
|
-1.3 Number of daytime voids
Standard Deviation 2.6
|
SECONDARY outcome
Timeframe: 12 weeks or last measurementPopulation: Analysis was performed on all enrolled participants data available even if the participant withdrew from study prior to completion of study.
Change in number of incontinence episodes defined as number of incontinence episodes at completion of PTNS (12 weeks or last measurement) compared to baseline number of incontinence episodes.
Outcome measures
| Measure |
Unilateral PTNS Change in Overactive Bladder Questionnaire Short Form Score
n=16 Participants
Change in overactive bladder symptom severity was measured by comparing last overactive bladder questionnaire score to overactive bladder questionnaire score at baseline for one ankle stimulation
|
Bilateral PTNS Change in Overactive Bladder Questionnaire Short Form Score
n=17 Participants
Change in overactive bladder symptom severity was measured by comparing last overactive bladder questionnaire score to overactive bladder questionnaire score at baseline for two ankle stimulation
|
|---|---|---|
|
Change in Number of Incontinence Episodes Per 24 Hours From Baseline to 12 Weeks or Last Measurement
|
-0.3 Number of incontinence episodes
Standard Deviation 3.6
|
-1.2 Number of incontinence episodes
Standard Deviation 1.3
|
SECONDARY outcome
Timeframe: 12 weeks or last measurementPopulation: Analysis was performed on all enrolled participants data available even if the participant withdrew from study prior to completion of study.
Change in number of nocturia episodes defined as number of nighttime voids at completion of PTNS (12 weeks or last measurement) compared to baseline number of nighttime voids.
Outcome measures
| Measure |
Unilateral PTNS Change in Overactive Bladder Questionnaire Short Form Score
n=10 Participants
Change in overactive bladder symptom severity was measured by comparing last overactive bladder questionnaire score to overactive bladder questionnaire score at baseline for one ankle stimulation
|
Bilateral PTNS Change in Overactive Bladder Questionnaire Short Form Score
n=9 Participants
Change in overactive bladder symptom severity was measured by comparing last overactive bladder questionnaire score to overactive bladder questionnaire score at baseline for two ankle stimulation
|
|---|---|---|
|
Change in Nocturia Episodes From Baseline to 12 Weeks or Last Measurement
|
-0.1 Number of nighttime voids
Standard Deviation 1.1
|
-0.8 Number of nighttime voids
Standard Deviation 1.4
|
SECONDARY outcome
Timeframe: 12 weeks or last measurementPopulation: Analysis was performed on all enrolled participants data available even if the participant withdrew from study prior to completion of study.
The incontinence impact questionnaire was used to measure the impact on quality of life. The questionnaire score ranges from 0 to 100 with higher scores indicating worse quality of life.
Outcome measures
| Measure |
Unilateral PTNS Change in Overactive Bladder Questionnaire Short Form Score
n=16 Participants
Change in overactive bladder symptom severity was measured by comparing last overactive bladder questionnaire score to overactive bladder questionnaire score at baseline for one ankle stimulation
|
Bilateral PTNS Change in Overactive Bladder Questionnaire Short Form Score
n=17 Participants
Change in overactive bladder symptom severity was measured by comparing last overactive bladder questionnaire score to overactive bladder questionnaire score at baseline for two ankle stimulation
|
|---|---|---|
|
Impact of Treatment on Quality of Life From Baseline to 12 Weeks or Last Measurement
|
-12.8 score on a scale
Standard Deviation 24.7
|
-19.3 score on a scale
Standard Deviation 18.9
|
Adverse Events
Unilateral PTNS
Bilateral PTNS
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place