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OpenTrials
Completed

NCT Number: NCT01189136

Treatment for Acute Postoperative Voiding Dysfunction

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.

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Key information

Conditions

Urinary Retention Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Male Urogenital Diseases Urination Disorders Urogenital Diseases Urologic Diseases

Age range

18 year–95 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Women & Infants Hospital of Rhode Island

Providence, Rhode Island, 02905, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Patient declines participation.

Treatment and study plan

PTNS Active Treatment

Device

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.

Sham Treatment

Other

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 outcomes

  1. Persistent Retention

    Time frame: 30 minutes

    Number of participants with persistent unsuccessful trial of void after the intervention

Secondary outcomes

  1. 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 outcomes

  1. 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.

  2. 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)

Sponsors and collaborators

Lead sponsor

Women and Infants Hospital of Rhode Island

Other

Registry information

Official study title

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

Acronym: PTNS

Important dates

Study start
2006
Primary completion
2013
Study completion
2013
First posted
Aug 26, 2010
Registry last updated
Feb 23, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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