NCT04448171

TENS Used for Pain Management During Office Cystoscopy Botox Injections

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

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 42 (actual)
• Sponsor: Mayo Clinic · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Overactive Bladder

Interventions

Type	Name	Description
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.
DEVICE	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.

Timeline

• Start date: 2020-10-28
• Primary completion: 2023-10-31
• Completion: 2023-12-31
• First posted: 2020-06-25
• Last updated: 2025-08-20
• Results posted: 2025-08-20

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study