Overactive BladderNCT04448171
TENS Used for Pain Management During Office Cystoscopy Botox Injections
A study testing Active TENS in people with Overactive Bladder, run by Mayo Clinic at 1 site in United States.
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 . Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Overactive Bladder
- What is being tested?
- Active TENS
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 42 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Oct 2020to 31 Dec 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
About this study
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
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 .
Read the 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
- Being tested
- Active TENS, Sham TENS
- Keywords
- Overactive Bladder, Botox injection - bladder, TENS
- Medical subject headings
- Urinary Bladder, Overactive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Activated TENS Unit with standard pain control measures | Active comparator | Activated TENS Unit with standard pain control measures during Office Based Cystoscopic Intra-detrusor Onabotulinumtoxin A Injection Receives: Device: Active TENS |
| Sham TENS Unit with standard pain control measures | Placebo comparator | Sham TENS Unit with standard pain control measures during Office Based Cystoscopic Intra-detrusor Onabotulinumtoxin A Injection Receives: Device: Sham TENS |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline; intra-procedure
Secondary outcomes (1)
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.
Measured: Postprocedure, 10 minutes following completion of cystoscopy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2020
- Study start28 Oct 2020
- Primary completion31 Oct 2023
- Study completion31 Dec 2023
Why it stopped: Low Enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Overactive BladderStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, John A. Occhino, Mayo Clinic
- Investigators
- John A Occhino, MD, MS, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04448171
- Sponsor's protocol ID
- 20-003510
- Status last verified
- Aug 2025
- First submitted
- 23 Jun 2020
- Last updated
- 20 Aug 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04448171
- Acronym / sponsor ID
- 20-003510
- Conditions
- Overactive Bladder
- Keywords
- Overactive Bladder, Botox injection - bladder, TENS
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Low Enrollment
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 28 Oct 2020 (actual)
- Primary completion
- 31 Oct 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 25 Jun 2020 (actual)
- Results
- Posted 20 Aug 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Activated TENS Unit with standard pain control measures | Active comparator | Device: Active TENSActivated TENS Unit with standard pain control measures during Office Based Cystoscopic Intra-detrusor Onabotulinumtoxin A Injection |
| Sham TENS Unit with standard pain control measures | Placebo comparator | Device: Sham TENSSham TENS Unit with standard pain control measures during Office Based Cystoscopic Intra-detrusor Onabotulinumtoxin A Injection |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Active TENSStandard 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 | Activated TENS Unit with standard pain control measures |
| Sham TENSStandard 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. | Device | Sham TENS Unit with standard pain control measures |
Primary outcome
Change in Participant Reported Pain Score From Baseline to Intra-Procedure
Time frame: Baseline; 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.
1 secondary outcome
Change in Participant Satisfaction From Post Procedure to 10 Minutes Following Completion of Cystoscopy
Time frame: Postprocedure, 10 minutes following completion of cystoscopy
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Overactive Bladder
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Predictive Value of Inflammatory Biomarkers for Mirabegron Response in Women With Overactive Bladder
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APPROVE Trial: Evaluating a Prescription Digital Therapeutic for Treatment of OAB in Women
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Not yet recruitingPhase 4
Behavioral and/or Mirabegron to Treat Urinary Symptoms in Parkinson Disease
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John A Occhino, MD, MS principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active TENS in people with Overactive Bladder, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 20 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 20 Aug 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Participant Reported Pain Score From Baseline to Intra-Procedure (time frame: Baseline; intra-procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2025; AzTrials last refreshed its copy on 7 Nov 2026.