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NCT Number: NCT06369922

TENS Analgesia During Outpatient Urethral Bulking for Stress Urinary Incontinence.

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.

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Key information

Conditions

Stress Incontinence Female Acute Pain Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Lower Urinary Tract Symptoms Male Urogenital Diseases Neurologic Manifestations Pain Pain Acute Pathological Conditions, Signs and Symptoms Signs and Symptoms Urinary Incontinence Urinary Incontinence, Stress Urinary Incontinence,Stress Urination Disorders Urogenital Diseases Urologic Diseases Urological Manifestations

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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 patient's 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:

  • A discrete 5-point Likert Scale to assess the internal consistency of the pain rating within the study
  • A satisfaction 10-point scale questionnaire
  • 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),
  • Length of procedure.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • • Women, Age ≥18 years
  • Diagnosis of SUI
  • Scheduled to undergo transurethral bulking in the office
  • Able to read/write English

Exclusion criteria

  • • 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

Treatment and study plan

TENS

Procedure

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 (the procedure typically takes 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 TENS

Procedure

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 (the procedure typically takes 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.

Primary outcomes

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

    Time frame: Before procedure

    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.

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

    Time frame: Approximately 2-5 minutes into the procedure

    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.

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

    Time frame: within 10 minutes after procedure

    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.

Secondary outcomes

  1. Mean pain measured by Likert scale

    Time frame: before procedure

    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

  2. Mean pain measured by Likert scale

    Time frame: Approximately 2-5 minutes into the procedure

    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

  3. Mean pain measured by Likert scale

    Time frame: within 10 minutes after procedure

    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

  4. Number of participants with side effects

    Time frame: within 10 minutes after procedure

    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.

  5. Mean satisfaction with the procedure

    Time frame: within 10 minutes after procedure

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

  6. TENS or NO TENS

    Time frame: within 10 minutes after procedure

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

Study contacts

Contact information is provided by the study sponsor or research team.

Diego Hernandez-Aranda, MD

CONTACT

[email protected]

585-487-3400

Jared M Floch, DO, MS

CONTACT

[email protected]

585-895-9301

Sponsors and collaborators

Lead sponsor

University of Rochester

Other

Registry information

Official study title

Transcutaneous Electrical Nerve Stimulation Analgesia During Outpatient Urethral Bulking for Stress Urinary Incontinence.

Acronym: TENSUB

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Apr 17, 2024
Registry last updated
May 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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