Posterior Tibial Nerve Stimulation vs. Sham - Full Text View

Sponsored by:	William Beaumont Hospitals
Information provided by:	William Beaumont Hospitals
ClinicalTrials.gov Identifier:	NCT00534521

Purpose

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	Intervention	Phase
Overactive Bladder	Device: Posterior Tibial Nerve Device Device: Sham	Phase III

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Randomized, Single Blind (Subject), Placebo Control, Parallel Assignment
Official Title:	Posterior Tibial Nerve Stimulation vs. Sham

Further study details as provided by William Beaumont Hospitals:

Primary Outcome Measures:

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

Enrollment:	30
Study Start Date:	September 2007
Study Completion Date:	September 2007

Arms	Assigned Interventions
Active Treatment Arm: Active Comparator 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.
Sham Arm: Sham Comparator 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.

Arms

Assigned Interventions

Active Treatment Arm: Active Comparator

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.

Sham Arm: Sham Comparator

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.

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

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)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00534521

Locations

United States, Michigan
William Beaumont Hospital
Royal Oak, Michigan, United States, 48073

Sponsors and Collaborators

William Beaumont Hospitals

Investigators

Principal Investigator:

Kenneth Peters, MD

William Beaumont Hospitals

More Information

No publications provided

Study ID Numbers:	2007-145
Study First Received:	September 24, 2007
Last Updated:	September 24, 2007
ClinicalTrials.gov Identifier:	NCT00534521 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by William Beaumont Hospitals:

overactive bladder
posterior tibial nerve stimulation

Study placed in the following topic categories:

Signs and Symptoms
Urinary Bladder, Overactive
Cystocele
Urologic Diseases
Clotrimazole
Miconazole

Antifungal Agents
Urinary Bladder Diseases
Tioconazole
Salicylhydroxamic acid
Ethanol

Additional relevant MeSH terms:

Urinary Bladder, Overactive
Anti-Infective Agents
Trypanocidal Agents
Antiprotozoal Agents
Urinary Bladder Diseases
Pharmacologic Actions
Urological Manifestations

Signs and Symptoms
Antiparasitic Agents
Urologic Diseases
Antifungal Agents
Therapeutic Uses
Salicylhydroxamic acid

ClinicalTrials.gov processed this record on May 07, 2009