Posterior Tibial Nerve Stimulation vs. Sham

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00534521
Recruitment Status : Completed
First Posted : September 26, 2007
Last Update Posted : September 26, 2007
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Overactive Bladder Device: Posterior Tibial Nerve Device Device: Sham Phase 3

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Official Title: Posterior Tibial Nerve Stimulation vs. Sham
Study Start Date : September 2007
Actual Study Completion Date : September 2007

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: Active Treatment Arm
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.
Device: Posterior 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.
Other Names:
  • PTNS device
  • Urgent® PC

Sham Comparator: Sham Arm
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.
Device: Sham
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.
Other Name: Streitberger needle

Primary Outcome Measures :
  1. The objective of this study is to determine the efficacy of a sham for posterior tibial nerve stimulation (PTNS). [ Time Frame: Prospective ]

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts 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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00534521

United States, Michigan
William Beaumont Hospital
Royal Oak, Michigan, United States, 48073
Sponsors and Collaborators
William Beaumont Hospitals
Principal Investigator: Kenneth Peters, MD William Beaumont Hospitals Identifier: NCT00534521     History of Changes
Other Study ID Numbers: 2007-145
First Posted: September 26, 2007    Key Record Dates
Last Update Posted: September 26, 2007
Last Verified: September 2007

Keywords provided by William Beaumont Hospitals:
overactive bladder
posterior tibial nerve stimulation

Additional relevant MeSH terms:
Urinary Bladder, Overactive
Urinary Bladder Diseases
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms