Efficacy of Retrograde Fill Vs Spontaneous Fill to Assess Voiding Function

Surgery Clinical Trial

Official title:

Efficacy of Retrograde Fill Vs Spontaneous FIll to Assess Voiding Function

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01091844
• Other study ID #: 09-1286
• Status: Completed
• Phase: N/A
• First received: March 22, 2010
• Last updated: October 12, 2010
• Start date: December 2009
• Est. completion date: August 2010

Study information

• Verified date: October 2010
• Source: University of North Carolina, Chapel Hill
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: August 2010
• Est. primary completion date: April 2010
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Surgery
• Urinary Retention

Intervention

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.

Locations

Country	Name	City	State
United States	UNC-Chapel Hill	Chapel Hill	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
University of North Carolina, Chapel Hill

Country where clinical trial is conducted

United States, 

References & Publications (2)

Bødker B, Lose G. Postoperative urinary retention in gynecologic patients. Int Urogynecol J Pelvic Floor Dysfunct. 2003 Jun;14(2):94-7. Epub 2003 Apr 23. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Presence of urinary retention		Postoperative Day 1	No