Efficacy of Retrograde Fill Vs Spontaneous Fill to Assess Voiding Function

University of North Carolina (UNC)

Status: Completed

Conditions: Urinary Retention; Surgery

Treatments: Procedure: Voiding Trial

Study type: Interventional

Funder types: Other

Identifiers

NCT01091844

09-1286

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

Spontaneous Fill Technique

Active Comparator group

Description:

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").

Treatment:

Procedure: Voiding Trial

Retrograde Fill Technique

Active Comparator group

Description:

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.

Treatment:

Procedure: Voiding Trial