TTNS vs PTNS in a County Hospital System.

Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center

Status: Completed

Conditions: Overactive Bladder

Treatments: Device: Tibial nerve stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT07353944

2023-32833-01

Details and patient eligibility

About

The goal of this clinical trial is to study whether transcutaneous tibial nerve stimulation (TTNS) is a feasible and satisfactory treatment for overactive bladder in Urogynecology patients who receive their care at a county hospital.

Researchers will compare outcomes with TTNS to patients who undergo percutaneous tibial nerve stimulation (PTNS).

The main questions it aims to answer are:

• Is TTNS non-inferior to PTNS in terms of OAB symptom severity?
• Are patients as satisfied with TTNS as they are with PTNS?
• Are patients' symptoms improved with TTNS?

Participants will:

• either undergo PTNS or be taught how to do TTNS therapy at home
• complete surveys about their bladder symptoms and satisfaction with treatment

Full description

Patients who consent to this study will be randomly assigned to either receive PTNS in clinic weekly, or TTNS every other day at home. The severity of their overactive bladder symptoms and satisfaction with treatment will be assessed before starting treatment as well as 6 weeks, 12 weeks and 6 months after starting treatment. The results of these surveys will be compared between groups to determine whether TTNS is non-inferior to PTNS in this particular patient population.

Enrollment: 70 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• age between 18 - 90 years old
• patient of the Urogynecology clinic at Harbor UCLA medical center
• diagnosis of overactive bladder
• patient elects non-pharmacologic treatment of overactive bladder
• English or Spanish speaking
• able to consent and participate in research

Exclusion criteria

• cognitive impairment or diagnosis of dementia
• diagnosis of neurogenic bladder
• prior midurethral sling procedure
• use of an electronic pacemaker
• current pregnancy
• incarcerated persons

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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70 participants in 2 patient groups

Percutaneous tibial nerve stimulation (PTNS)

Active Comparator group

Description:

Participants undergo weekly 30-minute percutaneous tibial nerve stimulation in our clinic. The PTNS device is a neuromodulation system comprised of an external signal generator attached to one electrode that is placed on the patient's foot, and the other to an acupuncture needle that is inserted in the patient's inner ankle. It delivers a low electrical signal (20 Hz, 200ms pulse width) to the posterior tibial nerve, adjusted to the participant's perception of stimulation without pain.

Treatment:

Device: Tibial nerve stimulation

Transcutaneous tibial nerve stimulation (TTNS)

Experimental group

Description:

Participants receive a TENS unit and are taught how to conduct TTNS therapy at home at their recruitment visit. The TENS unit is a neuromodulation system comprised of an external signal generator attached to one electrode that is placed on the patient's foot, and the other to an electrode patch that is inserted in the patient's inner ankle. It delivers a low electrical signal (20 Hz, 200ms pulse width) to the posterior tibial nerve, adjusted to the participant's perception of stimulation without pain. They will be instructed to conduct this therapy every other day at home.

Treatment:

Device: Tibial nerve stimulation