Posterior Tibial Nerve Stimulation vs. Sham

Posterior Tibial Nerve Stimulation vs. Sham

Sponsors

Lead Sponsor: William Beaumont Hospitals

Source William Beaumont Hospitals
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.

Overall Status Completed
Start Date September 2007
Completion Date September 2007
Phase Phase 3
Study Type Interventional
Primary Outcome
Measure Time Frame
The objective of this study is to determine the efficacy of a sham for posterior tibial nerve stimulation (PTNS). Prospective
Enrollment 30
Condition
Intervention

Intervention Type: Device

Intervention Name: Posterior Tibial Nerve Device

Description: 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.

Arm Group Label: Active Treatment Arm

Intervention Type: Device

Intervention Name: Sham

Description: 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.

Arm Group Label: Sham Arm

Other Name: Streitberger needle

Eligibility

Criteria:

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)

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: Accepts Healthy Volunteers

Overall Official
Last Name Role Affiliation
Kenneth Peters, MD Principal Investigator William Beaumont Hospitals
Location
Facility: William Beaumont Hospital
Location Countries

United States

Verification Date

September 2007

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: Active Treatment Arm

Type: Active Comparator

Description: Subjects will have their leg and foot draped to remain blinded to the test. They will be in a supine position with the knees abducted and flexed. The medial aspect of the lower extremity is palpated and a needle insertion site is identified. Between the posterior margin of the tibia and the soleus muscle, an acupuncture-like needle is inserted. An adhesive grounding pad is placed on the bottom of the foot just below the smallest toe. The needle and grounding pad are connected to the stimulator and the stimulation is increased as tolerated.

Label: Sham Arm

Type: Sham Comparator

Description: Since subjects with the PTNS will feel foot stimulation, the sham was devised to mimic this feeling without the tibial nerve being stimulated. Again the leg and foot will be draped and out of view from the subject. The medial aspect of the lower extremity is palpated (Figure 4) and the tibial nerve site is identified approximately 5 cm cephalad from the medial malleolus. A Streitberger needle is used at the tibial nerve insertion site to simulate needle placement without puncturing the skin. The needle will be taped in place as in the PTNS procedure. The "grounding pad" will be a gel electrode pad from a TENS unit device that is placed on the bottom of the foot just below the smallest toe.

Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Masking: Single (Participant)

Source: ClinicalTrials.gov