TENS Used for Pain Management During Office Cystoscopy Botox Injections

Overactive Bladder Clinical Trial

Official title:

Transcutaneous Electric Nerve Stimulation For Pain Control During Office Intra-detrusor Onabotulinumtoxin A Cystoscopy Injection for Overactive Bladder: A Phase III Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04448171
• Other study ID #: 20-003510
• Status: Recruiting
• Phase: N/A
• Start date: October 28, 2020
• Est. completion date: December 2025

Study information

• Verified date: June 2024
• Source: Mayo Clinic
• Contact: Karen P Ishitani, MSN
• Phone: 507-538-5355
• Email: ishitani.karen[@]mayo.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 .

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 2025
• Est. primary completion date: June 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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
• Has a spouse or first degree relative who has previously used TENS therapy within one year prior to study enrollment
• Currently has an implanted pacemaker or automatic cardiac defibrillator
• History of epilepsy
• Currently pregnant or within 12 weeks postpartum
• Unwilling to be randomized

Related Conditions & MeSH terms

• Overactive Bladder
• Urinary Bladder, Overactive

Intervention

Device:
• Active 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.
• Sham 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.

Locations

Country	Name	City	State
United States	Mayo Clinic in Rochester	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assess whether the TENS units is effective over standard pain control measures for intra-procedure pain management during office cystoscopic Intra-detrusor Onabotulinumtoxin A in women with OAB.	Compare the change in participant-reported numerical pain score using a 0-10 numerical pain scale at baseline and intra-procedure.	Baseline to intra-procedure
Secondary	Evaluate the effect of TENS units on participant satisfaction following cystoscopic intra-detrusor onabotulinumtoxin A injection in women with OAB.	Evaluate participant satisfaction using a 10 point Likert scale (1=complete dissatisfaction and 10=complete satisfaction)	Postprocedure, 10 minutes following completion of cystoscopy