Treatment for Acute Postoperative Voiding Dysfunction

NCT01189136 | Completed Results

• 1 other identifier: 06-0061
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

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.

Conditions

Urinary Retention

Keywords

Voiding dysfunction

Outcome Measures

Primary Outcomes (1)

• Persistent Retention

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

  30 minutes

Secondary Outcomes (1)

• Amount of Improvement in Voiding Efficiency

  30 minutes

Other Outcomes (2)

• Questionnaire Data - Impression of Allocation

  30 minutes

• Pain From Treatment

  30 minutes

Study Arms (2)

Sham treatment

SHAM COMPARATOR

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

PTNS Active Treatment

EXPERIMENTAL

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

Interventions

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.

PTNS Active Treatment

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

Sham treatment

Eligibility Criteria

• Age: 18 Years - 95 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Patient declines participation.

Sponsors & Collaborators

• Women and Infants Hospital of Rhode Island: lead

Study Sites (1)

Women & Infants Hospital of Rhode Island

Providence, Rhode Island, 02905, United States

Location

MeSH Terms

Conditions

Urinary Retention

Condition Hierarchy (Ancestors)

Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Results Point of Contact

• Title: Charles R. Rardin, MD
• Organization: Women & Infants Hospital of Rhode Island

crardin@wihri.org

401 453-7560

Study Officials

• Charles R Rardin, MD

  Women and Infants Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 20, 2010
• First Posted: August 26, 2010
• Study Start: July 1, 2006
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: February 23, 2017
• Results First Posted: November 23, 2016

Record last verified: 2017-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)