NCT02739256

Brief Summary

The primary aim of this study is to determine if normal bladder function (the ability to empty the bladder during spontaneous urination) after surgical repair of pelvic organ prolapse returns faster in patients who have a retrograde voiding trial the day of surgery versus patients who have a retrograde voiding trial on postoperative day one. Half of participants will have a voiding trial 4 hours after surgery, while the other half will have the voiding trial postoperative day one.

Trial Health

57
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Trial Health Score

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

Enrollment
57

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2016

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2016

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

March 10, 2016

Completed
1 month until next milestone

First Posted

Study publicly available on registry

April 15, 2016

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2017

Completed
Last Updated

June 27, 2018

Status Verified

June 1, 2018

Enrollment Period

1.1 years

First QC Date

March 10, 2016

Last Update Submit

June 25, 2018

Conditions

Urinary RetentionPelvic Organ Prolapse

Keywords

voiding trialpelvic organ prolapsepost-operative catheterization

Outcome Measures

Primary Outcomes (1)

  • time to return of normal bladder function

    5 days

Secondary Outcomes (5)

  • time to first ambulation

    24 hours

  • anxiety level

    24 hours

  • pain level

    24 hours

  • patient preference in the timing of the voiding trial

    24 hours

  • catheter associated urinary tract infections

    6 weeks

Study Arms (2)

voiding trial 4 hours post-op

EXPERIMENTAL
Procedure: Retrograde voiding trial

voiding trial post-op day 1

ACTIVE COMPARATOR
Procedure: Retrograde voiding trial

Interventions

Retrograde voiding trialPROCEDURE

A bladder test is performed after surgery for prolapse to make sure the patient can empty their bladder prior to discharge from the hospital. The test consists of filling the bladder with 300 mL of water and removing the catheter. Then the patient voids.

Also known as: Bladder Test
voiding trial 4 hours post-opvoiding trial post-op day 1

Eligibility Criteria

Age21 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • surgical management of pelvic organ prolapse requiring an overnight hospital admission

You may not qualify if:

  • same day surgery
  • non-ambulatory (allowed to use an assistive device)
  • inability to provide informed consent, age \< 21 years
  • pregnancy or desire for future pregnancy
  • systematic disease known to affect bladder function (Parkinson's disease, Multiple Sclerosis, Spina Bifida, spinal cord injury or trauma and neurogenic bladder)
  • known preoperative urinary retention (defined as a post-void residual \> 100mL)
  • an untreated urinary tract infection at the time of surgery
  • treatment at the time of surgery for urinary tract infection
  • symptoms of urinary tract infection on the day of surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Magee Women's Hospital of UPMC

Pittsburgh, Pennsylvania, 15213, United States

Location

Related Publications (4)

  • Oliphant SS, Lowder JL, Ghetti C, Zyczynski HM. Effect of a preoperative self-catheterization video on anxiety: a randomized controlled trial. Int Urogynecol J. 2013 Mar;24(3):419-24. doi: 10.1007/s00192-012-1868-y. Epub 2012 Jul 3.

    PMID: 22752014RESULT

  • Geller EJ, Hankins KJ, Parnell BA, Robinson BL, Dunivan GC. Diagnostic accuracy of retrograde and spontaneous voiding trials for postoperative voiding dysfunction: a randomized controlled trial. Obstet Gynecol. 2011 Sep;118(3):637-642. doi: 10.1097/AOG.0b013e318229e8dd.

    PMID: 21860294RESULT

  • Turner LC, Kantartzis K, Shepherd JP. Predictors of postoperative acute urinary retention in women undergoing minimally invasive sacral colpopexy. Female Pelvic Med Reconstr Surg. 2015 Jan-Feb;21(1):39-42. doi: 10.1097/SPV.0000000000000110.

    PMID: 25185611RESULT

  • Ellahi A, Stewart F, Kidd EA, Griffiths R, Fernandez R, Omar MI. Strategies for the removal of short-term indwelling urethral catheters in adults. Cochrane Database Syst Rev. 2021 Jun 29;6(6):CD004011. doi: 10.1002/14651858.CD004011.pub4.

    PMID: 34184246DERIVED

MeSH Terms

Conditions

Urinary RetentionPelvic Organ Prolapse

Condition Hierarchy (Ancestors)

Urination DisordersUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesProlapsePathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Officials

  • Charelle Carter-Brooks, MD

    Urogynecology Fellow

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 10, 2016

First Posted

April 15, 2016

Study Start

February 1, 2016

Primary Completion

March 1, 2017

Study Completion

March 1, 2017

Last Updated

June 27, 2018

Record last verified: 2018-06

Data Sharing

IPD Sharing
Will not share

Locations

US(1)