TENS Used for Pain Management During Office Cystoscopy Botox Injections

Mayo Clinic42 enrolled

Overview

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 .

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Overactive Bladder

Interventions

Active TENSDEVICE

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.

Sham TENSDEVICE

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.

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Mayo Clinic in Rochester

Rochester, Minnesota, United States

Outcomes

Primary Outcomes

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

Secondary Outcomes

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

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.