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Treatment for Acute Postoperative Voiding Dysfunction (PTNS)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Charles Rardin, Women and Infants Hospital of Rhode Island
ClinicalTrials.gov Identifier:
NCT01189136
First received: August 20, 2010
Last updated: December 21, 2012
Last verified: December 2012
History of Changes
  Purpose

If patients are unable to have their foley catheter removed because their bladder is not emptying well, they may be eligible for study participation. This study is designed to evaluate whether Posterior Tibial Nerve Stimulation is effective in improving bladdder function after surgery. Study participation is limited to one day.


Condition Intervention
Voiding Dysfunction
 Device: PTNS treatment
Other: Sham treatment

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Percutaneous Posterior Tibial Nerve Stimulation for the Treatment of Acute Postoperative Voiding Dysfunction

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Women and Infants Hospital of Rhode Island:

Primary Outcome Measures:
  • Unsuccessful voiding trial [ Time Frame: 30 minutes ] [ Designated as safety issue: No ]
    Persistence of unsuccessful voiding trial


Secondary Outcome Measures:
  • Voiding efficiency [ Time Frame: 30 minutes ] [ Designated as safety issue: No ]
    Improvement of voiding efficiency


Enrollment: 84
Study Start Date: July 2006
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Sham Comparator: Sham treatment
No electrical stimulation is actually received
 Other: Sham treatment
No electrical stimulation is given
Experimental: Peructaneous Tibial Nerve Stimulation
Patient receives PTNS for 30 minutes
 Device: PTNS treatment
Electrical stimulation is received

Detailed Description:

If patients fail a voiding trial (the test done to see if a foley catheter is ready to be removed after surgery), they may be offered participation in this trial. Patients are randomized to receive active treatment or a sham treatment. A small, accupuncture-type needle is inserted through the skin just above the ankle. A small, battery-powered generator will be attached to the needle. The generator will give a low-voltabe stimulation which is adjusted for comfort level and applied for 30 minutes. After treatemnt, the voiding trial will be repeated.

  Eligibility

Ages Eligible for Study:   18 Years to 95 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • First voiding trial after Urogynecological surgery shows that bladder is not emptying well.

Exclusion Criteria:

  • Patient declines participation.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01189136

Locations
United States, Rhode Island
Women & Infants Hospital of Rhode Island
Providence, Rhode Island, United States, 02905
Sponsors and Collaborators
Women and Infants Hospital of Rhode Island
Investigators
Principal Investigator: Charles R Rardin, MD Women and Infants Hospital
  More Information

No publications provided

Responsible Party: Charles Rardin, Principal Investigator, Women and Infants Hospital of Rhode Island
ClinicalTrials.gov Identifier: NCT01189136     History of Changes
Other Study ID Numbers: 06-0061, 06-0061
Study First Received: August 20, 2010
Last Updated: December 21, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Women and Infants Hospital of Rhode Island:
Voiding dysfunction

ClinicalTrials.gov processed this record on May 22, 2013