Ignite Creation Date:
2024-05-06 @ 8:23 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06369922
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-19
First Post:
2024-04-12
Brief Title:
TENS Analgesia During Outpatient Urethral Bulking for Stress Urinary Incontinence
Sponsor:
University of Rochester
Organization:
University of Rochester
Study Overview
Official Title:
Transcutaneous Electrical Nerve Stimulation Analgesia During Outpatient Urethral Bulking for Stress Urinary Incontinence
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TENSUB
Brief Summary:
This will be a double-blind randomized control trial in women with stress urinary incontinence who are undergoing an outpatient transurethral bulking procedure for stress urinary incontinence Subjects will be identified by the University of Rochester urologists and urogynecologists participating in the study who currently oversee stress 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 the cystoscopy with placebo TENS
Detailed Description:
This will be a double-blind randomized control trial in women with stress urinary incontinence who are undergoing outpatient transurethral bulking procedures These subjects will be identified by the University of Rochester urologists and urogynecologists participating in the study who oversee the patients stress urinary incontinence management The subjects will be asked to participate in this research project when the doctor is offering options for their SUI treatment
Subjects will be randomized into two groups One group will undergo transurethral bulking with TENS for analgesia and the second group will have the procedure performed with placebo TENS The application of the TENS device will be performed by a study team member who will know to what group the patient was randomized Both groups will be given the VAS satisfaction scale and 5-point Likert scale questionnaires to be answered before during and after they undergo treatment on the scheduled day of the procedure
The primary outcome will be a change in the VAS pain measurement Investigators hypothesized that TENS used during transurethral bulking injections would result in a 10-mm decrease in VAS compared to placebo TENS
Secondary outcomes will be
1 A discrete 5-point Likert Scale to assess the internal consistency of the pain rating within the study
2 A satisfaction 10-point scale questionnaire
3 Rate of side effects to the use of TENS skin irritation pain or burning at electrode site and transurethral bulking injections vasovagal symptoms dizziness nausea vomiting shoulder pain vertigo sweating fainting
4 Length of procedure
Subjects will be randomized into two groups One group will undergo transurethral bulking with TENS for analgesia and the second group will have the procedure performed with placebo TENS The application of the TENS device will be performed by a study team member who will know to what group the patient was randomized Both groups will be given the VAS satisfaction scale and 5-point Likert scale questionnaires to be answered before during and after they undergo treatment on the scheduled day of the procedure
The primary outcome will be a change in the VAS pain measurement Investigators hypothesized that TENS used during transurethral bulking injections would result in a 10-mm decrease in VAS compared to placebo TENS
Secondary outcomes will be
1 A discrete 5-point Likert Scale to assess the internal consistency of the pain rating within the study
2 A satisfaction 10-point scale questionnaire
3 Rate of side effects to the use of TENS skin irritation pain or burning at electrode site and transurethral bulking injections vasovagal symptoms dizziness nausea vomiting shoulder pain vertigo sweating fainting
4 Length of procedure
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None