AzTrials
AzTrials

Urinary IncontinenceTENSOBNCT05330117

Nerve Stimulation Using a TENS to Provide Pain Relief During Surgery for Overactive Bladder

A study testing TENS in people with Urinary Incontinence and Overactive Bladder, run by University of Rochester at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

This will be a double blind randomized control trial in men and women with urinary urge incontinence that are undergoing outpatient operative cystoscopy for Onabotulinumtoxin A chemo denervation as third line therapy for overactive bladder (OAB) or urinary urge incontinence (UUI). Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
TENS
Type of treatment
Surgery or procedure
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
100 participants
Where
1 siteUnited States
Study dates
14 Dec 2020to 3 Mar 2022
Phase
Interventional
Are there results?
None posted in the registry

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
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Men and Women, Age ≥18 years
  • Diagnosis of OAB/UUI,
  • Scheduled to undergo intravesical Botox injections in the office
  • Able to read/write English

Who cannot join

  • Currently undergoing Sacral Neuromodulation
  • Cutaneous damage such as ulcers or broken skin on target treatment area
  • Currently implanted cardiac pacemaker or defibrillator
  • Pre-procedural use of opioids for pain management, less than 8 hours from last dose
  • Participants with altered sensation below the umbilicus

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of Rochester Medical Center

    Rochester, New York, 14642

Other trials in United States

About this study

Official title: Transcutaneous Electrical Nerve Stimulation Analgesia During Outpatient Operative Cystoscopy for Overactive Bladder: A Randomized Control Trial (TENSOB Study)

This will be a double blind randomized control trial in men and women with urinary urge incontinence that are undergoing outpatient operative cystoscopy for Onabotulinumtoxin A chemo denervation as third line therapy for overactive bladder (OAB) or urinary urge incontinence (UUI). Subjects will be identified by the University of Rochester Urologists and Urogynecologists participating in the study who currently oversee urinary urge incontinence care. Subjects will be randomized into two groups. One group will be undergoing the cystoscopy with transcutaneous electrical nerve stimulation (TENS) for analgesia and the second group will have cystoscopy with placebo TENS.

Being tested
TENS, Control TENS
Medical subject headings
Urinary Incontinence, Urinary Bladder, Overactive, Acute Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TENSProcedure or surgery

    This device will then be used for deep transcutaneous nerve stimulation at the T10-L1 and S2-S4 levels. The device will be placed and activated 5 minutes before the procedure. and the device will remain active during the procedure and will be turned off as soon as the procedure is complete (procedure typically will take from 5-15 minutes). The TENS units have pre-program settings improving convenience, reproducibility and reliability. Study staff will be instructed to perform TENS using an "Acupuncture" mode on the provided TENS units. The amplitude will be adjusted to a comfortable sensation that does not cause pain using adhesive electrodes. One TENS unit is able to support 4 TENS electrodes. The TENS electrodes (8 cm x 5 cm) will be placed on bilateral paraspinal muscles. The intensity of the stimulation (Hz) will be adjusted to the subjective comfort of the subject.

  • Control TENSProcedure or surgery

    This device will then be used for deep transcutaneous nerve stimulation at the T10-L1 and S2-S4 levels. The device will be placed and activated 5 minutes before the procedure. and the device will remain active during the procedure and will be turned off as soon as the procedure is complete (procedure typically will take from 5-15 minutes). The TENS units have pre-program settings improving convenience, reproducibility and reliability. Study staff will be instructed to perform TENS using an "Acupuncture" mode on the provided TENS units. The amplitude will be adjusted to a comfortable sensation that does not cause pain using adhesive electrodes. One TENS unit is able to support 4 TENS electrodes. The TENS electrodes (8 cm x 5 cm) will be placed on bilateral paraspinal muscles. The intensity of the stimulation (Hz) will be adjusted to the subjective comfort of the subject.

Study groups in NCT05330117
Study groupRoleWhat they receive
Active TENSExperimentalIn the active treatment group, the TENS unit will remain on up to 30 minutes (10 minutes pre-procedure, during the procedure and during the questionnaires).
Receives: Procedure: TENS
Control TENSSham comparatorThe sham stimulation group will undergo the same procedure; however, the TENS stimulation current will be reduced to a minimal detectable level and turned off after 20 seconds.
Receives: Procedure: Control TENS

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Mean pain measured by Visual Analog Scale (VAS)

    The VAS for pain consists of a 100-mm-long horizontal line where 0-mm equals no pain and 100-mm equals worst possible pain.

    Measured: Baseline (Before procedure)

  2. Mean pain measured by Visual Analog Scale (VAS)

    The VAS for pain consists of a 100-mm-long horizontal line where 0-mm equals no pain and 100-mm equals worst possible pain.

    Measured: Approximately 2-5 minutes into the procedure

  3. Mean pain measured by Visual Analog Scale (VAS)

    The VAS for pain consists of a 100-mm-long horizontal line where 0-mm equals no pain and 100-mm equals worst possible pain.

    Measured: within 10 minutes after procedure

Secondary outcomes (6)

  1. Mean pain measured by Likert scale

    A discrete, 5-point verbal Likert scale including the following options: "no pain", "minimal pain", "moderate pain", "severe pain" and "worst pain possible" will be asked to patients

    Measured: before procedure

  2. Mean pain measured by Likert scale

    A discrete, 5-point verbal Likert scale including the following options: "no pain", "minimal pain", "moderate pain", "severe pain" and "worst pain possible" will be asked to patients

    Measured: Approximately 2-5 minutes into the procedure

  3. Mean pain measured by Likert scale

    A discrete, 5-point verbal Likert scale including the following options: "no pain", "minimal pain", "moderate pain", "severe pain" and "worst pain possible" will be asked to patients

    Measured: within 10 minutes after procedure

  4. Number of participants with side effects

    A check list of vasovagal symptoms will be handed to the study team member to complete if the subject reports any light headedness, nausea or sweating.

    Measured: within 10 minutes after procedure

  5. Mean satisfaction with the procedure

    A 1-10 point satisfaction scale will be used where 10 indicates higher satisfaction.

    Measured: within 10 minutes after procedure

  6. Number of participants who guessed correctly whether they were given the active TENS or placebo TENS

    Measured: within 10 minutes after procedure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Apr 2022
  2. Study start14 Dec 2020
  3. Primary completion3 Mar 2022
  4. Study completion3 Mar 2022

Resources

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, Care provider, Outcomes assessor
Enrolment
100 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05330117
Sponsor's protocol ID
STUDY00005257
Acronym
TENSOB
Status last verified
Apr 2022
First submitted
7 Apr 2022
Last updated
15 Apr 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Hernandez-Aranda D, Panza J, Eigg M, Greenstein M, Li D, O'Brien J, Warren G, Doyle PJ. Analgesia Using Transcutaneous Electric Nerve Stimulation in Office Bladder Chemodenervation, a Randomized Controlled Trial. Urogynecology (Phila). 2024 May 1;30(5):498-504. doi: 10.1097/SPV.0000000000001424. Epub 2023 Nov 6.

    PubMed 37930264

Questions about this trial

What is this clinical trial studying?

A study testing TENS in people with Urinary Incontinence and Overactive Bladder, run by University of Rochester 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 4 inclusion and 5 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: finished, as of the sponsor's last update on 15 Apr 2022. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Mean pain measured by Visual Analog Scale (VAS) (time frame: Baseline (Before procedure)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05330117, which also lists 1 linked publication.

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 15 Apr 2022.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in