Posterior Tibial Nerve Stimulation vs. Sham

NCT00534521 | Completed Phase 3

• 1 other identifier: 2007-145
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Overactive Bladder

Keywords

overactive bladder; posterior tibial nerve stimulation

Outcome Measures

Primary Outcomes (1)

• The objective of this study is to determine the efficacy of a sham for posterior tibial nerve stimulation (PTNS).

  Prospective

Study Arms (2)

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

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

Interventions

Posterior Tibial Nerve Device 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.

Also known as: PTNS device, Urgent® PC

Active Treatment Arm

Sham DEVICE

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.

Also known as: Streitberger needle

Sham Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Corewell Health East: lead

Study Sites (1)

William Beaumont Hospital

Royal Oak, Michigan, 48073, United States

Location

MeSH Terms

Conditions

Urinary Bladder, Overactive

Condition Hierarchy (Ancestors)

Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Kenneth Peters, MD

  Corewell Health East

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 24, 2007
• First Posted: September 26, 2007
• Study Start: September 1, 2007
• Study Completion: September 1, 2007
• Last Updated: September 26, 2007

Record last verified: 2007-09

Locations

US (1)