Posterior Tibial Nerve Stimulation vs. Sham

Overactive Bladder Clinical Trial

Official title:

Posterior Tibial Nerve Stimulation vs. Sham

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00534521
• Other study ID #: 2007-145
• Status: Completed
• Phase: Phase 3
• First received: September 24, 2007
• Last updated: September 24, 2007
• Start date: September 2007
• Est. completion date: September 2007

Study information

• Verified date: September 2007
• Source: William Beaumont Hospitals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: September 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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)

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject)

Related Conditions & MeSH terms

• Overactive Bladder
• Urinary Bladder, Overactive

Intervention

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
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.

Locations

Country	Name	City	State
United States	William Beaumont Hospital	Royal Oak	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
William Beaumont Hospitals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The objective of this study is to determine the efficacy of a sham for posterior tibial nerve stimulation (PTNS).		Prospective