TERMINATED

TENS Used for Pain Management During Office Cystoscopy Botox Injections

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Conditions

Overactive BladderBotox injection - bladderTENS

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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 .

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

Quick Facts

Study Start:2020-10-28
Study Completion:2023-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:TERMINATED

Study ID

NCT04448171

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Females age 18 years or older
  2. * Scheduled to receive intra-detrusor Onabotulinumtoxin-A injection for Overactive Bladder in the outpatient clinic
  3. * Reads, speaks, and understands the English language
  4. * Able to understand the requirements of the study, including randomization
  5. * Willing and able to provide written informed consent
  1. * Previous use of TENS therapy within one year prior to study enrollment
  2. * Allergy to adhesives
  3. * Currently has an implanted pacemaker or automatic cardiac defibrillator
  4. * History of epilepsy
  5. * Currently pregnant or within 12 weeks postpartum
  6. * Unwilling to be randomized

Contacts and Locations

Principal Investigator

John A Occhino, MD, MS
PRINCIPAL_INVESTIGATOR
Mayo Clinic

Study Locations (Sites)

Mayo Clinic in Rochester
Rochester, Minnesota, 55905
United States

Collaborators and Investigators

Sponsor: Mayo Clinic

  • John A Occhino, MD, MS, PRINCIPAL_INVESTIGATOR, Mayo Clinic

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2020-10-28
Study Completion Date2023-12-31

Study Record Updates

Study Start Date2020-10-28
Study Completion Date2023-12-31

Terms related to this study

Keywords Provided by Researchers

  • Overactive Bladder
  • Botox injection - bladder
  • TENS

Additional Relevant MeSH Terms

  • Overactive Bladder