Posterior Tibial Nerve Stimulation vs. Sham

Completed · Phase 3 · Has a placebo group

Conditions studied: Overactive Bladder

In brief

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.

Key facts

Study ID

NCT00534521

Run by

Corewell Health East

People needed

30

Starts

2007-09-01

Expected to finish

2007-09-01

Last updated by the study team

2007-09-26

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

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)

Where it is running

• William Beaumont Hospital — Royal Oak, Michigan, United States

Full record on ClinicalTrials.gov

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