Clinical trial NCT04448171: TENS Used for Pain Management During Office Cystoscopy Botox Injections
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Overactive Bladder
Keywords: Overactive Bladder
Botox injection - bladder
TENS
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2020-06-25
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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
* 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

Primary outcomes:
measure: 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.
timeFrame: Baseline to intra-procedure
Secondary outcomes:
measure: Evaluate the effect of TENS units on participant satisfaction following cystoscopic intra-detrusor onabotulinumtoxin A injection in women with OAB.
timeFrame: Postprocedure, 10 minutes following completion of cystoscopy
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: John A Occhino, MD, MS
role: PRINCIPAL_INVESTIGATOR
References: