Overactive Bladder
Conditions
Keywords
overactive bladder, posterior tibial nerve stimulation
Brief summary
The overall goal of this research is to determine the efficacy of a sham for posterior tibial nerve stimulation (PTNS). This novel design is needed in order to have a sham treatment that is similar to the actual treatment. The PTNS is used to treat urgency and frequency in people with overactive bladder (OAB). Until research is done using a sham component, we are unable to ascertain if the current use of PTNS is due to a placebo effect.
Detailed description
Subjects will be healthy volunteers who are recruited by word of mouth. At their office visit with the Nurse Practitioner (NP), the subject's history and medication list will be reviewed. The NP will randomize subjects into groups: one group with the PTNS on the right and sham on the left; the other group with the PTNS on the left and sham on the right. There will be a maximum of 30 subjects tested, and up to 50 people screened. The subjects will have 1 session for the testing of the PTNS vs sham that will include 15 minutes of stimulation as noted below. All participants will be blinded to the therapy they receive as described below.
Interventions
DEVICEPosterior Tibial Nerve Device
The PTNS device (Urgent® PC) is a minimally invasive neuromodulation system designed to deliver retrograde access to the sacral nerve through percutaneous electrical stimulation of the tibial nerve (PTNS). It is a combination of a stimulator and a lead set. The stimulator is a battery powered, external pulse generator and is designed, constructed, and manufactured for multiple use in conjunction with the lead set. The lead set (comprised of the lead wires, needle electrode, and alcohol pad) transfers the electrical current from the stimulator to the tibial nerve via the needle electrode. The tibial nerve travels up the leg to the sacral nerve plexus which regulates the bladder and pelvic floor function.
DEVICESham
This 2- piece needle, comprised of a needle handle and blunt-tip shaft feels like a slight prick when touched to the skin. However the shaft retracts as it appears to enter the skin but the skin is not punctured. The Streitberger needle specifically activates the dorsolateral prefrontal cortex, which is associated with the placebo effect.
Sponsors
Corewell Health East
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Male and female subjects \>18 years of age * Female subjects will be menopausal, or have had a tubal ligation or hysterectomy. * Capable of giving informed consent * Capable and willing to follow study related procedures
Exclusion criteria
* Pregnancy * InterStim * Bion * TENS * The subject is deemed unsuitable for enrollment in this study by the investigators based on their history or physical examination (including bleeding disorders)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The objective of this study is to determine the efficacy of a sham for posterior tibial nerve stimulation (PTNS). | Prospective |
Countries
United States
Outcome results
None listed