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Treatment for Acute Postoperative Voiding Dysfunction

NCT01189136 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 84

Last updated 2017-02-23

Study results available
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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.

Conditions

  • Urinary Retention

Interventions

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.

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

Sponsors & Collaborators

  • Women and Infants Hospital of Rhode Island

    lead OTHER

Principal Investigators

  • Charles R Rardin, MD · Women and Infants Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
95 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2006-07-31
Primary Completion
2013-12-31
Completion
2013-12-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01189136 on ClinicalTrials.gov