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Electrical Nerve Stimulation for Overactive Bladder a Comparison of Treatments

NCT01940367 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 114

Last updated 2016-04-28

No results posted yet for this study

Summary

The purpose of this study is to determine whether transcutaneous sacral nerve stimulation (TENS SNS) versus percutaneous tibial nerve stimulation (PTNS) is a more effective therapeutic option for subjects with idiopathic overactive bladder (OAB) who have failed conventional therapy. Our primary hypothesis is that TENS therapy is a more effective treatment option due to ease of use and improved subject compliance with this form of therapy.

Conditions

Interventions

DEVICE

PTNS (Percutaneous Tibial Nerve Stimulation

PTNS therapy is performed as follows; the subject sits in a frog leg position in a chair. The area where the needle will be placed is cleaned with an alcohol swab. A 34 gauge needle (equivalent to an acupuncture needle) is inserted percutaneously approximately 5 cm cephalad to the medial malleolus of the right or left ankle (subject choice) at a 60 degree angle. A surface electrode is placed on the medial aspect of the ipsilateral calcaneous. The needle and electrode are connected to a low voltage (9 V) electrical stimulator (Urgent PC). Stimulation current with a fixed frequency of 20 Hz and a pulse width of 200 msec is increased until flexion of the big toe or fanning of all toes becomes visible, or until the subject reports a tingling sensation across the heel or bottom of the foot. The current is then set to the highest level tolerable to the subject (0-10 mA) and the subject undergoes therapy for 30 minutes.

DEVICE

TENS (Transcutaneous Electrical Nerve Stimulation)

TENS therapy will be administered as follows: * Surface electrodes, 2" x 2" in diameter, will be placed over sacral foramen S2-4, bilaterally, using 2 channels (4 electrodes total) - Approximate locations are over posterior superior iliac spine and inferior lateral angle of sacrum. Sticker electrodes for the duration of the study will be issued to subjects. They are adhesive and can be re-used for up to 3-4 weeks with proper skin care and electrode care. * The electrodes will be connected to the TENS (Transcutaneous Electrical Nerve Stimulation) device and the following settings will be pre-set: * Mode: Burst * Cycle: 10 seconds * Frequency: 10 Hz * Pulse Width: 250 µs * Intensity: to subject comfort level

Sponsors & Collaborators

  • International Urogynecological Association

    collaborator OTHER

  • Section on Women's Health (Grant)

    collaborator UNKNOWN

  • Walter Reed National Military Medical Center

    lead FED

Principal Investigators

  • Mary E McVearry, DPT, WCS · Walter Reed National Military Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-10-31
Primary Completion
2017-03-31
Completion
2017-12-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01940367 on ClinicalTrials.gov