ClinicalTrials.Veeva

Menu

Transcutaneous Tibial Nerve Stimulation for Urgency Urinary Incontinence (TTeNS)

Kaiser Permanente logo

Kaiser Permanente

Status

Active, not recruiting

Conditions

Overactive Bladder
Urge Incontinence

Treatments

Device: transcutaneous electrical stimulation (TENS)
Device: transcutaneous tibial nerve stimulation (TTNS)

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

This is a single-center, double-blinded, randomized controlled trial evaluating the efficacy of TTNS versus a sham intervention. Both interventions will be performed by participants in their homes after standardized instruction. The primary outcome is a comparison of the mean change in OAB-q scores before and after treatment between the intervention and control groups. Changes in the number of urgency incontinence episodes and an estimation of cost effectiveness will additionally be measured. Intention to treat analysis will be performed.

Enrollment

99 estimated patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • ≥ 6 episodes urgency incontinence on 3-day voiding diary
  • Duration of symptoms ≥ 3 months
  • Off antimuscarinic or 3-adrenoreceptor agonist therapy for 2 weeks
  • No known neurologic disease
  • Ability to complete home sessions and clinic follow up
  • Ability to complete voiding diaries
  • Internet access and proficiency
  • English or Spanish-speaking

Exclusion criteria

  • Pregnant
  • Known or suspected urinary retention
  • Symptomatic urinary tract infection unresolved at the time of randomization
  • Recurrent urinary tract infection (≥ 3/12 months)
  • Bladder pain syndrome
  • Known or suspected advanced (stage III or IV) pelvic organ prolapse
  • Neurogenic bladder
  • Current or prior bladder malignancy
  • Current or previous use of bladder Botox injections, percutaneous tibial nerve stimulation, or sacral neuromodulation
  • Pacemaker or other implantable device
  • Disease affecting lower extremities
  • Bilateral metallic lower limb implant
  • Incarceration

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

99 participants in 2 patient groups

Intervention Group
Experimental group
Description:
30-minute treatments, twice weekly x12 weeks
Treatment:
Device: transcutaneous tibial nerve stimulation (TTNS)
Sham Group
Sham Comparator group
Description:
30-minute treatments, twice weekly x12 weeks
Treatment:
Device: transcutaneous electrical stimulation (TENS)

Trial contacts and locations

1

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems