Trial Outcomes & Findings for TENS Used for Pain Management During Office Cystoscopy Botox Injections (NCT NCT04448171)
NCT ID: NCT04448171
Last Updated: 2025-08-20
Results Overview
Using the participant-reported numerical pain scale, the change in participant reported pain was measured. This change was measured between two time points, baseline and intra-procedure. The participant-reported pain scale ranges from 0 (no pain) to 10 (worst pain) with higher scores indicating worse pain. When analyzing the data, the scale was multiplied by a factor of 10 to get a 100-point scale. Final results are reported using the 100-point scale ranging from 0 (no pain) to 100 (worst pain) with higher scores indicating worse pain.
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
42 participants
Primary outcome timeframe
Baseline; intra-procedure
Results posted on
2025-08-20
Participant Flow
Two participants were not randomized as they screen failed prior to randomization taking place.
Participant milestones
| Measure |
Activated TENS Unit With Standard Pain Control Measures
Activated TENS Unit with standard pain control measures during Office Based Cystoscopic Intra-detrusor Onabotulinumtoxin A Injection
Active TENS: Standard TENS unit with four pads affixed to the lower back area, were used in this arm. The TENS device was set to an active setting.
|
Sham TENS Unit With Standard Pain Control Measures
Sham TENS Unit with standard pain control measures during Office Based Cystoscopic Intra-detrusor Onabotulinumtoxin A Injection
Sham TENS: Standard TENS unit with four pads affixed to the lower back area, were used in this arm. The TENS device was set to an inactive setting.
|
|---|---|---|
|
Overall Study
STARTED
|
20
|
20
|
|
Overall Study
COMPLETED
|
18
|
20
|
|
Overall Study
NOT COMPLETED
|
2
|
0
|
Reasons for withdrawal
| Measure |
Activated TENS Unit With Standard Pain Control Measures
Activated TENS Unit with standard pain control measures during Office Based Cystoscopic Intra-detrusor Onabotulinumtoxin A Injection
Active TENS: Standard TENS unit with four pads affixed to the lower back area, were used in this arm. The TENS device was set to an active setting.
|
Sham TENS Unit With Standard Pain Control Measures
Sham TENS Unit with standard pain control measures during Office Based Cystoscopic Intra-detrusor Onabotulinumtoxin A Injection
Sham TENS: Standard TENS unit with four pads affixed to the lower back area, were used in this arm. The TENS device was set to an inactive setting.
|
|---|---|---|
|
Overall Study
Procedure Cancelled
|
1
|
0
|
|
Overall Study
Protocol Violation
|
1
|
0
|
Baseline Characteristics
TENS Used for Pain Management During Office Cystoscopy Botox Injections
Baseline characteristics by cohort
| Measure |
Active TENS
n=20 Participants
Receive TENS therapy
|
Sham TENS
n=20 Participants
No TENS therapy received
|
Total
n=40 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
72 years
n=5 Participants
|
72 years
n=7 Participants
|
72 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
20 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
40 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 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)
Not Hispanic or Latino
|
20 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
40 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
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
20 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
40 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
|
20 participants
n=5 Participants
|
20 participants
n=7 Participants
|
40 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline; intra-procedureUsing the participant-reported numerical pain scale, the change in participant reported pain was measured. This change was measured between two time points, baseline and intra-procedure. The participant-reported pain scale ranges from 0 (no pain) to 10 (worst pain) with higher scores indicating worse pain. When analyzing the data, the scale was multiplied by a factor of 10 to get a 100-point scale. Final results are reported using the 100-point scale ranging from 0 (no pain) to 100 (worst pain) with higher scores indicating worse pain.
Outcome measures
| Measure |
Activated TENS Unit With Standard Pain Control Measures
n=14 Participants
Activated TENS Unit with standard pain control measures during Office Based Cystoscopic Intra-detrusor Onabotulinumtoxin A Injection
Active TENS: Standard TENS unit with four pads affixed to the lower back area, were used in this arm. The TENS device was set to an active setting.
|
Sham TENS Unit With Standard Pain Control Measures
n=17 Participants
Sham TENS Unit with standard pain control measures during Office Based Cystoscopic Intra-detrusor Onabotulinumtoxin A Injection
Sham TENS: Standard TENS unit with four pads affixed to the lower back area, were used in this arm. The TENS device was set to an inactive setting.
|
|---|---|---|
|
Change in Participant Reported Pain Score From Baseline to Intra-Procedure
|
27.9 score on a scale
Standard Deviation 26.4
|
37.5 score on a scale
Standard Deviation 38.2
|
SECONDARY outcome
Timeframe: Postprocedure, 10 minutes following completion of cystoscopyUsing the 10-point Likert scale, the change in participant satisfaction was measured. This change was measured between two time points, post procedure and 10 minutes following completion of cystoscopy. Scores on the Likert scale range from 1 (complete dissatisfaction) to 10 (complete satisfaction), with higher scores indicating higher satisfaction.
Outcome measures
| Measure |
Activated TENS Unit With Standard Pain Control Measures
n=14 Participants
Activated TENS Unit with standard pain control measures during Office Based Cystoscopic Intra-detrusor Onabotulinumtoxin A Injection
Active TENS: Standard TENS unit with four pads affixed to the lower back area, were used in this arm. The TENS device was set to an active setting.
|
Sham TENS Unit With Standard Pain Control Measures
n=17 Participants
Sham TENS Unit with standard pain control measures during Office Based Cystoscopic Intra-detrusor Onabotulinumtoxin A Injection
Sham TENS: Standard TENS unit with four pads affixed to the lower back area, were used in this arm. The TENS device was set to an inactive setting.
|
|---|---|---|
|
Change in Participant Satisfaction From Post Procedure to 10 Minutes Following Completion of Cystoscopy
|
9.2 score on a scale
Standard Deviation 2.0
|
8.5 score on a scale
Standard Deviation 2.4
|
Adverse Events
Activated TENS Unit With Standard Pain Control Measures
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Sham TENS Unit With Standard Pain Control Measures
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Activated TENS Unit With Standard Pain Control Measures
n=20 participants at risk
Activated TENS Unit with standard pain control measures during Office Based Cystoscopic Intra-detrusor Onabotulinumtoxin A Injection
Active TENS: Standard TENS unit with four pads affixed to the lower back area, were used in this arm. The TENS device was set to an active setting.
|
Sham TENS Unit With Standard Pain Control Measures
n=20 participants at risk
Sham TENS Unit with standard pain control measures during Office Based Cystoscopic Intra-detrusor Onabotulinumtoxin A Injection
Sham TENS: Standard TENS unit with four pads affixed to the lower back area, were used in this arm. The TENS device was set to an inactive setting.
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
Minor Skin Reaction
|
10.0%
2/20 • Adverse events were collected from the time of informed consent through study completion, approximately 2 weeks.
|
5.0%
1/20 • Adverse events were collected from the time of informed consent through study completion, approximately 2 weeks.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place