Self-discontinuation of a Transurethral Catheter

NCT02996968 | Completed Results

• 1 other identifier: 16-075
• Study Type: interventional
• Target: 158
• Locations: 1 country
• Sites: 1

Brief Summary

This study is to determine if self-discontinuation of transurethral foley catheters in patients diagnosed with postoperative urinary retention (POUR), which is defined as the continued need for catheterization, following impatient pelvic organ prolapse surgery is non-inferior to office-discontinuation.

Conditions

Postoperative Urinary Retention

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Postoperative Urinary Retention

  Number of Participants with postoperative urinary retention (POUR) following pelvic reconstructive surgery for pelvic organ prolapse. Pour at 1-week was defined as continued catheterization on POD 6-8

  postoperative day 6-8

Study Arms (2)

Self-removal group

EXPERIMENTAL

The patients randomized to the self-removal group will be provided with a diagrammatic handout and will be instructed to remove their indwelling urinary catheter at home on the morning of Postoperative day 7.

Procedure: Self-removal

Office-removal group

NO INTERVENTION

The patients randomized to the office-removal group will visit the office for a repeat voiding trial on postoperative day 6-8 (postoperative day 7 will be encouraged). At this visit, the patients will undergo a backfill voiding trial.

Interventions

Self-removal PROCEDURE

Self-discontinuation of a transurethral catheter

Self-removal group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Undergoing vaginal vault suspension or robot-assisted laparoscopic sacrocolpopexy by a physician at Cincinnati Urogynecology Associates, TriHealth Inc.for the treatment of pelvic organ prolapse
• Failed voiding trial prior to discharge
• Concomitant procedures such as hysterectomy, suburethral sling, anterior or posterior colporrhaphy, bilateral salpingectomy or salpingooophorectomy

You may not qualify if:

• physical or mental impairment that would affect the subject's ability to self-remove indwelling urinary catheter, including patient's with Multiple Sclerosis, Dementia, Parkinsonism, or those who have impaired mobility or are wheelchair bound
• Bladder injury, fistula repair or other need for prolonged catheterization

Sponsors & Collaborators

• TriHealth Inc.: lead

Study Sites (1)

Cincinnati Urogynecology Associates

Cincinnati, Ohio, 45220, United States

Location

Related Publications (1)

• Shatkin-Margolis A, Yook E, Hill AM, Crisp CC, Yeung J, Kleeman S, Pauls RN. Self-Removal of a Urinary Catheter After Urogynecologic Surgery: A Randomized Controlled Trial. Obstet Gynecol. 2019 Nov;134(5):1027-1036. doi: 10.1097/AOG.0000000000003531.

  PMID: 31599827 DERIVED

Results Point of Contact

• Title: Abigail Shatkin-Margolis, MD
• Organization: TriHealth Inc.

Abigail_Shatkin-margolis@trihealth.com

513-463-4300

Study Officials

• Rachel Pauls, MD

  TriHealth - Cincinnati Urogynecology Associates

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 15, 2016
• First Posted: December 19, 2016
• Study Start: January 10, 2017
• Primary Completion: May 16, 2019
• Study Completion: May 16, 2019
• Last Updated: November 12, 2019
• Results First Posted: November 12, 2019

Record last verified: 2019-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)