Treatment for Acute Postoperative Voiding Dysfunction

Not Applicable

Completed

• Conditions: Urinary Retention
• Interventions: Other: Sham treatment; Device: PTNS Active Treatment

• Registration Number: NCT01189136
• Lead Sponsor: Women and Infants Hospital of Rhode Island

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.

Study Timeline

• Study Start: 2006-07
• Study First Submitted: 2010-08-20
• Study First Submitted QC: 2010-08-25
• Study First Posted: 2010-08-26
• Primary Completion: 2013-12
• Study Completion: 2013-12
• Results First Submitted: 2016-01-08
• Results First Submitted QC: 2016-10-03
• Results First Posted: 2016-11-23
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-09
• Last Update Posted: 2017-02-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 84

Inclusion Criteria

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

Exclusion Criteria

• Patient declines participation.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sham treatment	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
PTNS Active Treatment	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

Primary Outcome Measures

Name	Time	Method
Persistent Retention	30 minutes	Number of participants with persistent unsuccessful trial of void after the intervention

Secondary Outcome Measures

Name	Time	Method
Amount of Improvement in Voiding Efficiency	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.

Trial Locations

Locations (1)

Women & Infants Hospital of Rhode Island; 🇺🇸 Providence, Rhode Island, United States