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Efficacy of Retrograde Fill Vs Spontaneous Fill to Assess Voiding Function

Efficacy of Retrograde Fill Vs Spontaneous FIll to Assess Voiding Function

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01091844
Enrollment
50
Registered
2010-03-24
Start date
2009-12-31
Completion date
2010-08-31
Last updated
2010-10-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Surgery, Urinary Retention

Keywords

voiding trial, urinary retention, catheterization, Urinary retention after gynecologic surgery

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.

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.

Interventions

PROCEDUREVoiding 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.

Sponsors

University of North Carolina, Chapel Hill
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Presence of urinary retentionPostoperative Day 1

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 28, 2026