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Treatment for Acute Postoperative Voiding Dysfunction (PTNS)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01189136
First Posted: August 26, 2010
Last Update Posted: February 23, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Charles Rardin, Women and Infants Hospital of Rhode Island
  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
Urinary Retention Device: PTNS Active Treatment Other: Sham treatment

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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:


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

Primary Outcome Measures:
  • Persistent Retention [ Time Frame: 30 minutes ]
    Number of participants with persistent unsuccessful trial of void after the intervention


Secondary Outcome Measures:
  • Amount of Improvement in Voiding Efficiency [ Time Frame: 30 minutes ]
    Improvement of voiding efficiency, as measured by dividing the volume voided by the total volume (voided volume + retained volume) per participant. Each participant is evaluated separately, and the mean percentage of improvement was calculated for each arm.


Other Outcome Measures:
  • Questionnaire Data - Impression of Allocation [ Time Frame: 30 minutes ]
    Participants were asked to guess to which treatment arm they had been allocated ("PTNS" "Sham" or "I Don't Know"). Outcome was measured as the number of patients in each arm accurately determining their allocation.

  • Pain From Treatment [ Time Frame: 30 minutes ]
    Patient-reported discomfort attributable to the study intervention (0-10 Likert scale, with higher numbers representing greater pain)


Enrollment: 84
Study Start Date: July 2006
Study Completion Date: December 2013
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Sham Comparator: Sham treatment
34 gauge needle inserted 3cm above the medial ankle, but nonconductive cables are connected, so that no electrical stimulation is applied, over a 30-minute treatment period
Other: Sham treatment
34 gauge needle inserted 3cm above the medial ankle, but nonconductive cables are connected, so that no electrical stimulation is applied, over a 30-minute treatment period
Experimental: PTNS Active Treatment
34 gauge needle inserted 3cm above the medial ankle, and cables are connected to the PTNS stimulator device. Stimulation is provided, per manufacturer directions, over a 30-minute treatment period
Device: PTNS Active Treatment
34 gauge needle inserted 3cm above the medial ankle, and cables are connected to the PTNS stimulator device. Stimulation is provided, per manufacturer directions, over a 30-minute treatment period.

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 95 Years   (Adult, Senior)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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 ( Other Identifier: WIHRI )
First Submitted: August 20, 2010
First Posted: August 26, 2010
Results First Submitted: January 8, 2016
Results First Posted: November 23, 2016
Last Update Posted: February 23, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: No plans to make IPD available

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

Additional relevant MeSH terms:
Urinary Retention
Urination Disorders
Urologic Diseases