Status:
TERMINATED
INvestigation of TENS Efficacy Versus Posterior Tibial Nerve Stimulation for Overactive Bladder
Lead Sponsor:
University of New Mexico
Conditions:
Overactive Bladder
Overactive Bladder Syndrome
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief Summary
The objective of this research is to perform a non-masked, non-inferiority randomized controlled trial to assess the quality of life (QOL) of women with idiopathic overactive bladder (OAB) before and ...
Detailed Description
The investigators plan to perform an unmasked, non-inferiority randomized controlled trial to determine if the quality of life is improved with the use of TENS compared to PTNS for urgency urinary inc...
Eligibility Criteria
Inclusion
- Female Subjects ≥18 years of age
- OAB, UUI or Mixed Urinary Incontinence with urgency predominant symptoms and more bother from UUI than stress urinary incontinence
- Failed trial of conservative therapy (including bladder training, fluid modification, diet modification, caffeine restriction, or pelvic floor training) -Failed trial of at least one pharmacologic treatment (anticholinergics, β3- adrenoceptor agonist) either due to inability to take the medication, adverse reaction to medication, or no improvement on medication
- Willing to complete study questionnaires
- Willing to adhere to 12 office visits for PTNS over 3 months if randomized to that arm
- No contraindication to undergoing PTNS or TENS therapy
Exclusion
- Age \< 18 years
- Presence of urinary fistula
- Male genital anatomy
- Undergoing evaluation or treatment of recurrent (2 or more infections in the last 6 months or 3 or more infections in the last 12 months) or current urinary tract infection
- Current Bladder stones
- Bladder cancer or suspected bladder cancer
- Gross Hematuria
- Pregnancy or planning to become pregnant during the study
- Cognitive impairment
- Central or peripheral neurologic disorders such as multiple sclerosis, Parkinson's disease, spina bifida, spinal cord lesions, etc.
- Metal implants such as pacemaker, implantable defibrillator, or metal implants where PTNS or TENS device needs to be placed (ankle/leg)
- Uncontrolled diabetes
- Diabetes with peripheral nerve involvement
- Current use of anticoagulants (excluding aspirin)
- Current use of anticholinergics or use within the last 4 weeks
- Current use of botox bladder injections or bladder botox injection within the last year (12 months)
- Current use of sacral neuromodulation therapy or currently implanted sacral neuromodulation device or leads
- Bladder outlet obstruction
- Urinary retention or gastric retention
- Painful Bladder Syndrome/Interstitial Cystitis
- Unable to be contacted for follow up by telephone
- Inability to speak/read/understand English or Spanish
Key Trial Info
Start Date :
June 30 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2025
Estimated Enrollment :
27 Patients enrolled
Trial Details
Trial ID
NCT05309993
Start Date
June 30 2022
End Date
August 1 2025
Last Update
October 31 2025
Active Locations (1)
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1
University of New Mexico
Albuquerque, New Mexico, United States, 87106