Overactive Bladder
Conditions
Keywords
Overactive Bladder, Botox injection - bladder, TENS
Brief summary
The purpose of this study is to determine how Transcutaneous Electric Nerve Stimulation (TENS) units affects pain management during office cystoscopic Botox injections and patient satisfaction with the procedure .
Detailed description
Overactive bladder (OAB) is a symptom complex pronounced by urinary urgency, affecting up to 12% of the adult population, with a significant negative impact quality on the life. Cystoscopic intra-detrusor onabotulinumtoxin A is used for the treatment of OAB in participants who do not tolerate or adequately respond to oral anticholinergic medications. The response to the onabotulinumtoxin A injection is transient and requires repeat injections roughly every 6-7 months. Adequate pain control during this procedure is essential for success in the office setting. Options for adequate pain control during office-based cystoscopy procedures are limited. Currently, varying pain control strategies are being used including local anesthesia (intra-urethral lidocaine, intra-vesicular lidocaine solution), distraction techniques (conversation/music/'squeeze balls'), aromatherapy, intramuscular analgesia, sedation and a combination of these techniques. Despite this, participants often experience pain during the procedure. Trans-cutaneous Electrical Nerve Stimulation (TENS) is a non-pharmacologic, non-invasive and safe method of pain control that involves delivery of electrical impulses to the skin, resulting in a reduction in perceived pain. TENS units have been successfully used for procedural pain management during office hysteroscopy and office colonoscopy. TENS may also help reduce pain during office cystoscopy. The study is a two arm phase III double-blind, randomized, placebo-controlled trial looking at the effect of TENS unit on pain in participants receiving office based cystoscopic onabotulinum toxin A injection for overactive bladder at the Mayo Clinic in Rochester, Minnesota.
Interventions
DEVICEActive TENS
Standard TENS unit with four pads affixed to the lower back area, will be used in this arm. The TENS device will be set to an active setting.
DEVICESham TENS
Standard TENS unit with four pads affixed to the lower back area, will be used in this arm. The TENS device will be set to an inactive setting.
Sponsors
Mayo Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Masking description
The participant, the physician administering the Botox, and the study coordinator (outcomes assessor) assigned to the study will be blinded to the randomization. Both groups of participants will receive the TENS unit electrode placement by the assigned clinical nurse who is not blinded.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Females age 18 years or older * Scheduled to receive intra-detrusor Onabotulinumtoxin-A injection for Overactive Bladder in the outpatient clinic * Reads, speaks, and understands the English language * Able to understand the requirements of the study, including randomization * Willing and able to provide written informed consent
Exclusion criteria
* Previous use of TENS therapy within one year prior to study enrollment * Allergy to adhesives * Currently has an implanted pacemaker or automatic cardiac defibrillator * History of epilepsy * Currently pregnant or within 12 weeks postpartum * Unwilling to be randomized
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Participant Reported Pain Score From Baseline to Intra-Procedure | Baseline; intra-procedure | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Participant Satisfaction From Post Procedure to 10 Minutes Following Completion of Cystoscopy | Postprocedure, 10 minutes following completion of cystoscopy | Using 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. |
Countries
United States
Participant flow
Pre-assignment details
Two participants were not randomized as they screen failed prior to randomization taking place.
Participants by arm
| Arm | Count |
|---|---|
| Active TENS Receive TENS therapy | 20 |
| Sham TENS No TENS therapy received | 20 |
| Total | 40 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Procedure Cancelled | 1 | 0 |
| Overall Study | Protocol Violation | 1 | 0 |
Baseline characteristics
| Characteristic | Active TENS | Total | Sham TENS |
|---|---|---|---|
| Age, Continuous | 72 years | 72 years | 72 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 20 Participants | 40 Participants | 20 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 20 Participants | 40 Participants | 20 Participants |
| Region of Enrollment United States | 20 participants | 40 participants | 20 participants |
| Sex: Female, Male Female | 20 Participants | 40 Participants | 20 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 20 | 0 / 20 |
| other Total, other adverse events | 2 / 20 | 1 / 20 |
| serious Total, serious adverse events | 0 / 20 | 0 / 20 |
Outcome results
Primary
Change in Participant Reported Pain Score From Baseline to Intra-Procedure
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.
Time frame: Baseline; intra-procedure
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Activated TENS Unit With Standard Pain Control Measures | Change in Participant Reported Pain Score From Baseline to Intra-Procedure | 27.9 score on a scale | Standard Deviation 26.4 |
| Sham TENS Unit With Standard Pain Control Measures | Change in Participant Reported Pain Score From Baseline to Intra-Procedure | 37.5 score on a scale | Standard Deviation 38.2 |
Secondary
Change in Participant Satisfaction From Post Procedure to 10 Minutes Following Completion of Cystoscopy
Using 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.
Time frame: Postprocedure, 10 minutes following completion of cystoscopy
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Activated TENS Unit With Standard Pain Control Measures | Change in Participant Satisfaction From Post Procedure to 10 Minutes Following Completion of Cystoscopy | 9.2 score on a scale | Standard Deviation 2 |
| Sham TENS Unit With Standard Pain Control Measures | Change in Participant Satisfaction From Post Procedure to 10 Minutes Following Completion of Cystoscopy | 8.5 score on a scale | Standard Deviation 2.4 |