Efficacy of Retrograde Fill Vs Spontaneous Fill to Assess Voiding Function

Efficacy of Retrograde Fill Vs Spontaneous FIll to Assess Voiding Function

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.

Study Overview

• Status: Completed
• Conditions: Surgery; Urinary Retention
• Intervention / Treatment: Procedure: Voiding Trial

Detailed Description

Subjects will be enrolled in the study when presenting to the UNC gynecology outpatient clinic for surgical preoperative evaluation. After surgery, each woman will undergo a voiding trial to assess for urinary retention after surgery. This is currently performed on all patients undergoing surgery involving prolapse or incontinence. At UNC this is usually performed by allowing the bladder to spontaneously fill, then allowing the patient to void and afterward catheterizing the patient to check a postvoid residual ("spontaneous fill" technique). In this study, we will also assess bladder emptying separately 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. Both of these techniques will be performed. The order in which the two techniques will be performed will be randomized. We will then compare the outcomes of these two techniques of voiding trials to see if they are equivalent in assessing urinary retention. Of note, the retrograde fill technique is standard at other institutions and is not considered experimental.

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27599
      • UNC-Chapel Hill

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: DIAGNOSTIC
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Spontaneous Fill Technique; 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; 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.
ACTIVE_COMPARATOR: Retrograde Fill Technique; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Presence of urinary retention	Postoperative Day 1

Collaborators and Investigators

• Sponsor: University of North Carolina, Chapel Hill
• Investigators: Principal Investigator: Kelly Hankins, MD, University of North Carolina, Chapel Hill

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: December 1, 2009
• Primary Completion (ACTUAL): April 1, 2010
• Study Completion (ACTUAL): August 1, 2010

Study Registration Dates

• First Submitted: March 22, 2010
• First Submitted That Met QC Criteria: March 23, 2010
• First Posted (ESTIMATE): March 24, 2010

Study Record Updates

• Last Update Posted (ESTIMATE): October 13, 2010
• Last Update Submitted That Met QC Criteria: October 12, 2010
• Last Verified: October 1, 2010

More Information

Terms related to this study

• Keywords: voiding trial, urinary retention, catheterization; Urinary retention after gynecologic surgery
• Additional Relevant MeSH Terms: Urologic Diseases; Urination Disorders; Urinary Retention
• Other Study ID Numbers: 09-1286