Treatment for Acute Postoperative Voiding Dysfunction

Voiding Dysfunction Clinical Trial

— PTNS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01189136
• Other study ID #: 06-0061
• Secondary ID: 06-0061
• Status: Completed
• Phase: N/A
• First received: August 20, 2010
• Last updated: June 12, 2015
• Start date: July 2006
• Est. completion date: December 2013

Study information

• Verified date: June 2015
• Source: Women and Infants Hospital of Rhode Island
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 84
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 95 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• Patient declines participation.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Voiding Dysfunction

Intervention

Device:
• PTNS treatment
Electrical stimulation is received

Other:
• Sham treatment
No electrical stimulation is given

Locations

Country	Name	City	State
United States	Women & Infants Hospital of Rhode Island	Providence	Rhode Island

Sponsors (1)

Lead Sponsor	Collaborator
Women and Infants Hospital of Rhode Island

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Unsuccessful voiding trial	Persistence of unsuccessful voiding trial	30 minutes	No
Secondary	Voiding efficiency	Improvement of voiding efficiency	30 minutes	No