Transcutaneous Electric Nerve Stimulation For Pain Control During Office Intra-detrusor Onabotulinumtoxin A Cystoscopy Injection for Overactive Bladder: A Phase III Randomized Controlled Trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Overactive Bladder
- Sponsor
- Mayo Clinic
- Enrollment
- 42
- Locations
- 1
- Primary Endpoint
- Change in Participant Reported Pain Score From Baseline to Intra-Procedure
- Status
- Terminated
- Last Updated
- 8 months ago
Overview
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.
Investigators
John A. Occhino
Associate Professor of Obstetrics and Gynecology
Mayo Clinic
Eligibility Criteria
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
Outcomes
Primary Outcomes
Change in Participant Reported Pain Score From Baseline to Intra-Procedure
Time Frame: 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 Outcomes
- Change in Participant Satisfaction From Post Procedure to 10 Minutes Following Completion of Cystoscopy(Postprocedure, 10 minutes following completion of cystoscopy)