TENS Used for Pain Management During Office Cystoscopy Botox Injections
Primary Purpose
Overactive Bladder
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Active TENS
Sham TENS
Sponsored by
About this trial
This is an interventional treatment trial for Overactive Bladder focused on measuring Overactive Bladder, Botox injection - bladder, TENS
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
Sites / Locations
- Mayo Clinic in RochesterRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Activated TENS Unit with standard pain control measures
Sham TENS Unit with standard pain control measures
Arm Description
Activated TENS Unit with standard pain control measures during Office Based Cystoscopic Intra-detrusor Onabotulinumtoxin A Injection
Sham TENS Unit with standard pain control measures during Office Based Cystoscopic Intra-detrusor Onabotulinumtoxin A Injection
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04448171
Brief Title
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
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 28, 2020 (Actual)
Primary Completion Date
May 2024 (Anticipated)
Study Completion Date
May 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overactive Bladder
Keywords
Overactive Bladder, Botox injection - bladder, TENS
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Masking Description
The participant, the physician administering the Botox, and the study coordinator (outcomes assessor) assigned to the study will be blinded to the randomization. Both groups of participants will receive the TENS unit electrode placement by the assigned clinical nurse who is not blinded.
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Activated TENS Unit with standard pain control measures
Arm Type
Active Comparator
Arm Description
Activated TENS Unit with standard pain control measures during Office Based Cystoscopic Intra-detrusor Onabotulinumtoxin A Injection
Arm Title
Sham TENS Unit with standard pain control measures
Arm Type
Placebo Comparator
Arm Description
Sham TENS Unit with standard pain control measures during Office Based Cystoscopic Intra-detrusor Onabotulinumtoxin A Injection
Intervention Type
Device
Intervention Name(s)
Active TENS
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Sham TENS
Intervention Description
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.
Primary Outcome Measure Information:
Title
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.
Description
Compare the change in participant-reported numerical pain score using a 0-10 numerical pain scale at baseline and intra-procedure.
Time Frame
Baseline to intra-procedure
Secondary Outcome Measure Information:
Title
Evaluate the effect of TENS units on participant satisfaction following cystoscopic intra-detrusor onabotulinumtoxin A injection in women with OAB.
Description
Evaluate participant satisfaction using a 10 point Likert scale (1=complete dissatisfaction and 10=complete satisfaction)
Time Frame
Postprocedure, 10 minutes following completion of cystoscopy
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Karen P Ishitani, MSN
Phone
507-538-5355
Email
ishitani.karen@mayo.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Maureen A Lemens, BSN
Phone
507-293-1487
Email
lemens.maureen@mayo.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John A Occhino, MD, MS
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic in Rochester
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Karen P Ishitani, MSN
Phone
507-538-5355
Email
ishitani.karen@mayo.edu
First Name & Middle Initial & Last Name & Degree
Maureen A Lemens, BSN
Phone
507-293-1487
Email
lemens.maureen@mayo.edu
First Name & Middle Initial & Last Name & Degree
John A Occhino, MD, MS
12. IPD Sharing Statement
Links:
URL
https://www.mayo.edu/research/clinical-trials
Description
Mayo Clinic Clinical Trials
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TENS Used for Pain Management During Office Cystoscopy Botox Injections
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