NCT01091844

Brief Summary

Purpose: The purpose of this study is to determine if two different methods of performing a postoperative voiding trial are equivalent in evaluating urinary retention after gynecologic surgery. Participants: The participants in this study will be women who have undergone gynecologic surgery at UNC-Chapel Hill.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2009

Shorter than P25 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

Study Start

First participant enrolled

December 1, 2009

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

March 22, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 24, 2010

Completed
8 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2010

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2010

Completed
Last Updated

October 13, 2010

Status Verified

October 1, 2010

Enrollment Period

4 months

First QC Date

March 22, 2010

Last Update Submit

October 12, 2010

Conditions

Urinary RetentionSurgery

Keywords

voiding trial, urinary retention, catheterizationUrinary retention after gynecologic surgery

Outcome Measures

Primary Outcomes (1)

  • Presence of urinary retention

    Postoperative Day 1

Study Arms (2)

Spontaneous Fill Technique

ACTIVE COMPARATOR

We allow the bladder to spontaneously fill, then allow the patient to void and afterward catheterize the patient to check a postvoid residual ("spontaneous fill" technique").

Procedure: Voiding Trial

Retrograde Fill Technique

ACTIVE COMPARATOR

We assess bladder emptying by filling the bladder retrograde through the catheter already in place with 300 mL of saline and then removing the catheter and allowing the patient to void ("retrograde-fill" technique). We will determine postvoid residual indirectly by subtracting voided volume from the 300 mL infused volume. No catheterization will be performed with this technique unless they void less than 200 mL.

Procedure: Voiding Trial

Interventions

Voiding TrialPROCEDURE

After surgery, each woman will undergo a voiding trial to assess for urinary retention after surgery. This is performed on all patients undergoing surgery involving prolapse or incontinence. There are two methods commonly used to perform a voiding trial: Spontaneous Fill and Retrograde Fill techniques. Both are considered standard of care. The goal of the study is to perform both on each patient to assess their equivalency. There are no experimental interventions taking place.

Retrograde Fill TechniqueSpontaneous Fill Technique

Eligibility Criteria

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

You may qualify if:

  • \. Women undergoing surgical correction of pelvic organ prolapse or urinary incontinence

You may not qualify if:

  • Unwillingness to participate in the investigation.
  • Inability to give informed consent.
  • Known preoperative voiding dysfunction
  • Plan for suprapubic catheter placement at time of surgery.
  • Age less than 18
  • Non-English speaking

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UNC-Chapel Hill

Chapel Hill, North Carolina, 27599, United States

Location

Related Publications (3)

  • Bodker B, Lose G. Postoperative urinary retention in gynecologic patients. Int Urogynecol J Pelvic Floor Dysfunct. 2003 Jun;14(2):94-7. doi: 10.1007/s00192-003-1038-3. Epub 2003 Apr 23.

    PMID: 12851750RESULT

  • Partoll LM. Efficacy of tension-free vaginal tape with other pelvic reconstructive surgery. Am J Obstet Gynecol. 2002 Jun;186(6):1292-5; discussion 1295-8. doi: 10.1067/mob.2002.123736.

    PMID: 12066111RESULT

  • 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: 21860294DERIVED

MeSH Terms

Conditions

Urinary Retention

Condition Hierarchy (Ancestors)

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

Study Officials

  • Kelly Hankins, MD

    University of North Carolina, Chapel Hill

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 22, 2010

First Posted

March 24, 2010

Study Start

December 1, 2009

Primary Completion

April 1, 2010

Study Completion

August 1, 2010

Last Updated

October 13, 2010

Record last verified: 2010-10

Locations

US(1)