NCT03373773

Brief Summary

The purpose of this study is to evaluate the patient satisfaction with voiding assessment remotely after removal of Foley catheter at home by the patient or her caregiver compared to removal at the office by a healthcare provider in patients who have been diagnosed to have voiding difficulty after pelvic reconstructive surgery.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
78

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 11, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 14, 2017

Completed
3 months until next milestone

Study Start

First participant enrolled

March 12, 2018

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 19, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 19, 2021

Completed
Last Updated

August 29, 2022

Status Verified

August 1, 2022

Enrollment Period

3.4 years

First QC Date

December 11, 2017

Last Update Submit

August 23, 2022

Conditions

Voiding Disorders

Keywords

pelvic reconstructive surgeryfoley catheterFoley removalUrogynecologyUrinary RetentionGynecologic surgery

Outcome Measures

Primary Outcomes (1)

  • Patient Satisfaction

    At the routine 2-4 week post-operative visit, patients will be given an internally developed 5 item visual analogue scale regarding their experience with the Foley-catheter removal. The item used as the primary outcome measure will ask "How satisfied were you with the overall removal process of the Foley catheter?" Lower scores indicate less satisfaction, higher scores higher satisfaction.

    Up to 4 weeks

Secondary Outcomes (4)

  • Removal Method Negative Emotions

    Up to 4 weeks

  • Removal Method Recommendation

    Up to 4 weeks

  • Removal Method Convenience

    Up to 4 weeks

  • Removal Method Preference

    Up to 4 weeks

Study Arms (2)

Home Removal

ACTIVE COMPARATOR

Patients will be randomly allocated to two groups: subjects in one group will remove their indwelling Foley catheter at home and will have voiding assessment remotely based on their voiding characteristics (a Force of Stream of \>5/10 indicates that the patient has adequate bladder function), and the other group will follow up in the office for Foley catheter removal and voiding trial. Subjects in this arm will remove the Foley catheter at home.

Procedure: Foley catheter removal

Office Removal

ACTIVE COMPARATOR

Patients will be randomly allocated to two groups: subjects in one group will remove their indwelling Foley catheter at home and will have voiding assessment remotely based on their voiding characteristics (a Force of Stream of \>5/10 indicates that the patient has adequate bladder function), and the other group will follow up in the office for Foley catheter removal and voiding trial. Subjects in this arm will remove the Foley catheter in a medical office.

Procedure: Foley catheter removal

Interventions

Foley catheter removalPROCEDURE

After reinsertion of the Foley catheter, both groups of women will be given instructions on urinary catheter and bag management, this will be done by an RN as per standard protocol. Prior to discharge, every subject from the home removal group as well as their significant other/caregiver/family member will receive a standardized education session and written and illustrated instructions on Foley catheter removal from RN, per standard protocol. They will be provided with the syringe for catheter removal, urine collection pan, and a diary to record their voiding quality and quantity. Both groups of women will have the catheter removal in 2 days.

Home RemovalOffice Removal

Eligibility Criteria

Age18 Years - 85 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Women with post-operative voiding difficulty requiring catheterization after pelvic reconstructive surgery or surgery for urinary incontinency.

You may not qualify if:

  • A Pelvic Reconstructive Surgery/Urogynecology fellow or attending physician may deem patients ineligible based on patients post-operative voiding trial.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yale University

New Haven, Connecticut, 06510, United States

Location

Related Publications (1)

  • Popiel P, Getaneh F, Yeh J, Rickey L, Bercik R, Harmanli O. Voided Volume for Assessment of Bladder Emptying After Female Pelvic Floor Surgery: A Randomized Controlled Trial. Urogynecology (Phila). 2022 Dec 1;28(12):811-818. doi: 10.1097/SPV.0000000000001230. Epub 2022 Jun 22.

    PMID: 36409638DERIVED

MeSH Terms

Conditions

Urinary Retention

Condition Hierarchy (Ancestors)

Urination DisordersUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Study Officials

  • Oz Harmanli

    Yale University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 11, 2017

First Posted

December 14, 2017

Study Start

March 12, 2018

Primary Completion

August 19, 2021

Study Completion

August 19, 2021

Last Updated

August 29, 2022

Record last verified: 2022-08

Locations

US(1)