Treatment for Acute Postoperative Voiding Dysfunction (PTNS)

Women and Infants Hospital of Rhode Island

Status: Completed

Conditions: Urinary Retention

Treatments: Other: Sham treatment; Device: PTNS Active Treatment

Study type: Interventional

Funder types: Other

Identifiers

NCT01189136

06-0061 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 84 patients

Sex: Female

Ages: 18 to 95 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• Patient declines participation.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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84 participants in 2 patient groups

Sham treatment

Sham Comparator group

Description:

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

Treatment:

Other: Sham treatment

PTNS Active Treatment

Experimental group

Description:

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

Treatment:

Device: PTNS Active Treatment