Status:
COMPLETED
Posterior Tibial Nerve Stimulation (PTNS) Plus Mirabegron to Treat Refractory OAB Symptoms (PTNS-M Study)
Lead Sponsor:
University of Alabama at Birmingham
Conditions:
Overactive Bladder
Eligibility:
FEMALE
18+ years
Phase:
PHASE4
Brief Summary
Abstract Introduction: Urgency Urinary Incontinence (UUI) is a common condition with a prevalence of 9-31% in women in the United States. Despite current treatments, a high number of women have sympt...
Detailed Description
Specific Aims: Introduction/Background: Urgency Urinary Incontinence (UUI) remains a challenging clinical problem for urogynecologists as they treat women and seek to find better therapies. There is ...
Eligibility Criteria
Inclusion
- Female patients \> 18 years old at UAB facilities with refractory urgency urinary incontinence that have failed first line and second line treatments
- Ability to consent
- Ability to complete all study related items and interviews
Exclusion
- Patients with a history of any known or determined urinary retention or urinary tract obstruction
- PVR \> 150 ml in clinic prior to the start of PTNS
- History of bladder augmentation surgery
- Patients who are pregnant or who have the suspicion of pregnancy
- Uncontrolled hypertension
- Hypersensitivity to mirabegron
- Superficial and/or deep skin infection where PTNS intervention is required
- Spinal cord injury or clinically significant neurological disorders known to affect urgency urinary incontinence
- Bleeding diathesis
- Failure of previous third line treatment options such as sacral neuromodulation, PTNS, or Botox
- Pacemaker, implantable defibrillator
- Current use of Interstim sacral nerve stimulator or TENS in the pelvic region, back, or legs
- Coagulopathy
- Chronic swollen, infected, inflamed skin or skin eruptions (e.g., phlebitis, thrombophlebitis, varicose veins) in the region where the PTNS needles or surface electrodes would be placed
- Metal implant in foot/toes near TENS electrode location
- Marked sensory deficit (numbness) of feet or ankles in the region where the PTNS needles or surface electrodes would be placed
- Currently pregnant or planning to become pregnant during the course of the study
- Unwilling to use acceptable form of contraceptive if the participant is of childbearing potential
- Unable or unwilling to complete the 3-day bladder diary
- Visual impairment prohibiting reading the paper diary
- Inability to provide informed consent, complete questionnaires independently, or to attend intervention sessions
- Unable to speak, read, or write in English
Key Trial Info
Start Date :
October 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 15 2023
Estimated Enrollment :
54 Patients enrolled
Trial Details
Trial ID
NCT04907032
Start Date
October 1 2021
End Date
April 15 2023
Last Update
July 20 2023
Active Locations (1)
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1
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35249