NCT05353400

Brief Summary

This study aims to investigate whether patients who self-remove their indwelling transurethral catheters on POD 1 have similar rates of postoperative catheter reinsertion for urinary retention (within the first 7 days after surgery) compared with those who undergo catheter self-removal on POD 3.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
9

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 25, 2022

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 29, 2022

Completed
2 months until next milestone

Study Start

First participant enrolled

June 29, 2022

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 6, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 6, 2023

Completed
Last Updated

May 6, 2023

Status Verified

April 1, 2023

Enrollment Period

9 months

First QC Date

April 25, 2022

Last Update Submit

May 3, 2023

Conditions

Urinary Retention Postoperative

Outcome Measures

Primary Outcomes (1)

  • Percentage of patients requiring re-insertion of a transurethral urinary catheter

    Percentage of patients with urinary retention requiring re-insertion of a transurethral urinary catheter or needing to do self catheterization within one week of surgery after catheter self-discontinuation on either POD 1 or POD 3 following pelvic reconstructive surgery utilizing ERAS protocol.

    7 days

Secondary Outcomes (7)

  • Short Term Catheter Burden Questionnaire

    7 days

  • Urinary Force of stream

    7 days

  • Urinary tract infection rate

    30 days

  • Number of patient phone calls

    7 days

  • Number of visits

    30 days

  • +2 more secondary outcomes

Study Arms (2)

(Intervention group): self-removal of transurethral catheter on POD 1

EXPERIMENTAL

Subjects will self-remove transurethral catheter at home on postop day 1

Other: Early urinary catheter removal

(Standard practice group): self-removal of transurethral catheter on POD 3

ACTIVE COMPARATOR

Subjects will self-remove transurethral catheter at home on postop day 3

Other: Urinary catheter removal on POD 3

Interventions

Early urinary catheter removalOTHER

Early catheter removal

Also known as: Catheter Removal on POD 1
(Intervention group): self-removal of transurethral catheter on POD 1
Urinary catheter removal on POD 3OTHER

Catheter removal on POD 3

(Standard practice group): self-removal of transurethral catheter on POD 3

Eligibility Criteria

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

You may qualify if:

  • English speaking Age 18+ Undergoing pelvic reconstructive surgery with ERAS protocol Incomplete bladder emptying after same day VT in PACU (as defined by an ultrasound or straight catheter post void residual of greater than 50% the total instilled volume within 10 minutes following a void postoperatively) Able to complete a telephone appointment on either postoperative day 1 or 3

You may not qualify if:

  • Active urinary tract infection, defined by CDC criteria Patients undergoing pelvic reconstructive surgery where ERAS protocol is not utilized (examples: isolated Labiaplasty, chemodenervation with onabotulinum toxin A, urethral bulking, mid-urethral sling, sacral neuromodulation) Contraindication to ERAS protocol and/or its medications Elevated pre-op PVR greater than 200mL (on urodynamic testing or uroflow or straight catheter sample, that remains elevated after prolapse is reduced) Limited manual dexterity (limiting self-removal of catheter) Intra-op cystotomy or urinary tract injury Planned long term catheterization (e.g., fistula repair, urethral diverticulum) Planned hospital admission or patients who are not discharged from hospital the same day of their surgery Pregnancy Dependent on catheterization to void preoperatively Patients who request clean intermittent catheterization (CIC) after immediate failed VT Neurological conditions that affect voiding function (examples: spinal cord lesions, multiple sclerosis, Parkinson's disease, past stroke history with residual neurologic deficits) Concomitant surgical procedure by another service Conversion to open surgery Patients discharged to nursing home or rehabilitation care facility

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Atrium Health

Charlotte, North Carolina, 28203, United States

Location

Study Officials

  • Megan Tarr

    Wake Forest University Health Sciences

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

April 25, 2022

First Posted

April 29, 2022

Study Start

June 29, 2022

Primary Completion

April 6, 2023

Study Completion

April 6, 2023

Last Updated

May 6, 2023

Record last verified: 2023-04

Data Sharing

IPD Sharing
Will not share

Locations

US(1)