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Treatment for Acute Postoperative Voiding Dysfunction (PTNS)

This study has been completed.
Information provided by (Responsible Party):
Charles Rardin, Women and Infants Hospital of Rhode Island Identifier:
First received: August 20, 2010
Last updated: October 3, 2016
Last verified: October 2016
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 treatment
Other: Sham treatment

Study Type: Interventional
Study Design: Allocation: Randomized
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:

Further study details as provided by 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
No electrical stimulation is given
Experimental: Peructaneous Tibial Nerve Stimulation
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 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.

Ages Eligible for Study:   18 Years to 95 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

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

Exclusion Criteria:

  • Patient declines participation.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01189136

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
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 Identifier: NCT01189136     History of Changes
Other Study ID Numbers: 06-0061  06-0061 
Study First Received: August 20, 2010
Results First Received: January 8, 2016
Last Updated: October 3, 2016
Individual Participant Data  
Plan to Share IPD: No
Plan Description: No plans to make IPD available

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

Additional relevant MeSH terms:
Urinary Retention
Urination Disorders
Urologic Diseases processed this record on February 17, 2017