Treatment for Acute Postoperative Voiding Dysfunction (PTNS)
Primary Purpose
Urinary Retention
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
PTNS Active Treatment
Sham treatment
Sponsored by
About this trial
This is an interventional treatment trial for Urinary Retention focused on measuring Voiding dysfunction
Eligibility Criteria
Inclusion Criteria:
- First voiding trial after Urogynecological surgery shows that bladder is not emptying well.
Exclusion Criteria:
- Patient declines participation.
Sites / Locations
- Women & Infants Hospital of Rhode Island
Arms of the Study
Arm 1
Arm 2
Arm Type
Sham Comparator
Experimental
Arm Label
Sham treatment
PTNS Active Treatment
Arm Description
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
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
Outcomes
Primary Outcome Measures
Persistent Retention
Number of participants with persistent unsuccessful trial of void after the intervention
Secondary Outcome Measures
Amount of Improvement in Voiding Efficiency
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.
Full Information
NCT ID
NCT01189136
First Posted
August 20, 2010
Last Updated
January 9, 2017
Sponsor
Women and Infants Hospital of Rhode Island
1. Study Identification
Unique Protocol Identification Number
NCT01189136
Brief Title
Treatment for Acute Postoperative Voiding Dysfunction
Acronym
PTNS
Official Title
Percutaneous Posterior Tibial Nerve Stimulation for the Treatment of Acute Postoperative Voiding Dysfunction
Study Type
Interventional
2. Study Status
Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
July 2006 (undefined)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
December 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Women and Infants Hospital of Rhode Island
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urinary Retention
Keywords
Voiding dysfunction
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
84 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Sham treatment
Arm Type
Sham Comparator
Arm Description
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
Arm Title
PTNS Active Treatment
Arm Type
Experimental
Arm Description
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
Intervention Type
Device
Intervention Name(s)
PTNS Active Treatment
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Sham treatment
Intervention Description
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
Primary Outcome Measure Information:
Title
Persistent Retention
Description
Number of participants with persistent unsuccessful trial of void after the intervention
Time Frame
30 minutes
Secondary Outcome Measure Information:
Title
Amount of Improvement in Voiding Efficiency
Description
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.
Time Frame
30 minutes
Other Pre-specified Outcome Measures:
Title
Questionnaire Data - Impression of Allocation
Description
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.
Time Frame
30 minutes
Title
Pain From Treatment
Description
Patient-reported discomfort attributable to the study intervention (0-10 Likert scale, with higher numbers representing greater pain)
Time Frame
30 minutes
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
95 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
First voiding trial after Urogynecological surgery shows that bladder is not emptying well.
Exclusion Criteria:
Patient declines participation.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Charles R Rardin, MD
Organizational Affiliation
Women and Infants Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Women & Infants Hospital of Rhode Island
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02905
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
No plans to make IPD available
Learn more about this trial
Treatment for Acute Postoperative Voiding Dysfunction
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