Treatment for Acute Postoperative Voiding Dysfunction

Study Overview
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Brief Summary
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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
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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.

Official Title
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Percutaneous Posterior Tibial Nerve Stimulation for the Treatment of Acute Postoperative Voiding Dysfunction

Conditions
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Urinary Retention

Intervention / Treatment
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* Device: PTNS Active Treatment
* Other: Sham treatment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: First voiding trial after Urogynecological surgery shows that bladder is not emptying well. Exclusion Criteria: Patient declines participation.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 95 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sham Comparator: Sham treatment<br>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<br>* 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<br>|
| Experimental: PTNS Active Treatment<br>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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Persistent Retention | Number of participants with persistent unsuccessful trial of void after the intervention | 30 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 30 minutes | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Voiding dysfunction