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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

August 20, 2010
December 21, 2012
July 2006
December 2013   (final data collection date for primary outcome measure)
Unsuccessful voiding trial [ Time Frame: 30 minutes ] [ Designated as safety issue: No ]
Persistence of unsuccessful voiding trial
Same as current
Complete list of historical versions of study NCT01189136 on ClinicalTrials.gov Archive Site
Voiding efficiency [ Time Frame: 30 minutes ] [ Designated as safety issue: No ]
Improvement of voiding efficiency
Same as current
Not Provided
Not Provided
 
Treatment for Acute Postoperative Voiding Dysfunction
Percutaneous Posterior Tibial Nerve Stimulation for the Treatment of Acute Postoperative Voiding Dysfunction

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.

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.
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Voiding Dysfunction
  • Device: PTNS treatment
    Electrical stimulation is received
  • Other: Sham treatment
    No electrical stimulation is given
  • Sham Comparator: Sham treatment
    No electrical stimulation is actually received
    Intervention: Other: Sham treatment
  • Experimental: Peructaneous Tibial Nerve Stimulation
    Patient receives PTNS for 30 minutes
    Intervention: Device: PTNS treatment
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
84
December 2013
December 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

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

Exclusion Criteria:

  • Patient declines participation.
Female
18 Years to 95 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01189136
06-0061, 06-0061
No
Charles Rardin, Women and Infants Hospital of Rhode Island
Women and Infants Hospital of Rhode Island
Not Provided
Principal Investigator: Charles R Rardin, MD Women and Infants Hospital
Women and Infants Hospital of Rhode Island
December 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP