Clinical trial NCT01091844: Efficacy of Retrograde Fill Vs Spontaneous Fill to Assess Voiding Function
Official title: Efficacy of Retrograde Fill Vs Spontaneous FIll to Assess Voiding Function
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Urinary Retention
Surgery
Keywords: voiding trial, urinary retention, catheterization
Urinary retention after gynecologic surgery
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
First posted: 2010-03-24
Enrollment: 50
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: DIAGNOSTIC

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.

Eligibility 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

Primary outcomes:
measure: Presence of urinary retention
timeFrame: Postoperative Day 1
Secondary outcomes:
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: UNC-Chapel Hill
state: North Carolina
Study officials:
affiliation: University of North Carolina, Chapel Hill
name: Kelly Hankins, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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. doi: 10.1067/mob.2002.123736.
citation: 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.