Posterior Tibial Nerve Stimulation vs. Sham

Status Completed

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.

Clinical Trial 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 Design

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

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT00534521
Study type	Interventional
Source	William Beaumont Hospitals
Contact
Status	Completed
Phase	Phase 3
Start date	September 2007
Completion date	September 2007

View Details

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