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OpenTrials
Completed

NCT Number: NCT03595215

Posterior Tibial Nerve Stimulation's Effectiveness in UI Frequency in Overactive Patients in Home

This pilot clinical study, which focuses on feasibility and proof-of-principle, will be conducted in 11 female subjects (55-100 years old) with UI. Subjects will use the device three times a week for 8 weeks and complete 3-day "voiding diaries" to record instances of UI episodes and OAB quality of life.

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Key information

Conditions

Overactive Bladder Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Lower Urinary Tract Symptoms Male Urogenital Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms Urinary Bladder Diseases Urinary Bladder, Overactive Urogenital Diseases Urologic Diseases Urological Manifestations

Age range

55 year–100 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Stanford University Medical Center

Palo Alto, California, 94304, United States

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Females
  • 55-100 years old
  • Have an average urinary frequency of ≥ 8 voids per 24 hours (based on a pre-treatment 3-day voiding "training" diary)
  • Have self-reported bladder symptoms of more than 3 months
  • Are ambulatory and able to use the toilet independently
  • Have been off antimuscarinics, anticholinergics or beta-3 agonists for at least 2 weeks prior to enrollment OR on a stable dose for the prior 3 months
  • Patient has urinary urge incontinence of ≥ 8 episodes from a 3-day diary (with incontinence associated at urge level moderate or severe)
  • Able to provide informed consent
  • Capable and willing to follow all study-related procedures

Exclusion criteria

  • Have primary complaint of stress urinary incontinence
  • Have a pacemaker or implantable defibrillator
  • Had botox injections in the bladder or pelvic floor muscles in the past 12 months
  • Have a current urinary tract or vaginal infection
  • Have an active implantable SNS device (InterStim & Bion)
  • Have been diagnosed with peripheral neuropathy or nerve damage
  • Currently pregnant
  • Deemed unsuitable for enrollment in study by the investigator based on subjects' history or physical examination

Treatment and study plan

TENS

Device

Transcutaneous electrical nerve stimulation

Primary outcomes

  1. Change in Urge Incontinence Episodes

    Time frame: Baseline and 8 weeks

Secondary outcomes

  1. Change in Micturitions Per Day

    Time frame: Baseline and 8 weeks

    Mean number of urinary voids per day (taken over a 3-day period)

  2. Change in Health-related Quality of Life (HRQL)

    Time frame: Baseline and 8 weeks

    Change in incontinence health-related quality of life (HRQL) scores compared to pre-treatment. The survey consists of 13 questions that can be scored from 1 to 6. Lower scores correspond with better quality of life. The lowest score possible is 13 and the highest is 78.

Sponsors and collaborators

Lead sponsor

Theranova, L.L.C.

Industry

Collaborators

  • Stanford University

Registry information

Acronym: OAB Aim 2

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Jul 23, 2018
Registry last updated
May 21, 2021

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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