Efficacy of Retrograde Fill Vs Spontaneous Fill to Assess Voiding Function

This study has been completed.
Sponsor:
Information provided by:
University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier:
NCT01091844
First received: March 22, 2010
Last updated: October 12, 2010
Last verified: October 2010
  Purpose

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.


Condition Intervention
Urinary Retention
Surgery
Procedure: Voiding Trial

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Efficacy of Retrograde Fill Vs Spontaneous FIll to Assess Voiding Function

Resource links provided by NLM:


Further study details as provided by University of North Carolina, Chapel Hill:

Primary Outcome Measures:
  • Presence of urinary retention [ Time Frame: Postoperative Day 1 ] [ Designated as safety issue: No ]

Enrollment: 50
Study Start Date: December 2009
Study Completion Date: August 2010
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01091844

Locations
United States, North Carolina
UNC-Chapel Hill
Chapel Hill, North Carolina, United States, 27599
Sponsors and Collaborators
University of North Carolina, Chapel Hill
Investigators
Principal Investigator: Kelly Hankins, MD University of North Carolina, Chapel Hill
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Kelly Hankins, MD - PI, Elizabeth Geller, MD - Faculty Advisor, UNC-Chapel Hill
ClinicalTrials.gov Identifier: NCT01091844     History of Changes
Other Study ID Numbers: 09-1286
Study First Received: March 22, 2010
Last Updated: October 12, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by University of North Carolina, Chapel Hill:
voiding trial, urinary retention, catheterization
Urinary retention after gynecologic surgery

Additional relevant MeSH terms:
Urinary Retention
Urination Disorders
Urologic Diseases

ClinicalTrials.gov processed this record on July 24, 2014