Evaluating the Optimal Volume Voided for Passage of a Backfill-Assisted Voiding Trial Following Urogynecologic Surgery

Voiding Dysfunction Clinical Trial

Official title:

A Randomized Controlled Single-Blinded Study Evaluating the Optimal Volume Voided for Passage of a Backfill-Assisted Voiding Trial Following Urogynecologic Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05820139
• Other study ID #: IRB00091698
• Status: Completed
• Phase: N/A
• Start date: July 11, 2023
• Est. completion date: February 26, 2024

Study information

• Verified date: March 2024
• Source: Wake Forest University Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Urinary retention can lead to bladder over-distention, ischemia, and long-term voiding dysfunction, and early identification of urinary retention can help prevent these adverse events

Description:

Postoperative voiding trials (VT) can identify as well as prevent postoperative urinary retention. Voiding trial protocols vary by provider and healthcare facilities/institutions as there is no consensus on how to prevent postoperative urinary retention optimally. Identification of an optimal VT could not only help decrease adverse events associated with urinary retention but also decrease postoperative catheter-associated urinary tract infection (CAUTI) rates, unplanned hospital or clinic visits, and decrease patient discomfort while increasing patient satisfaction.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: February 26, 2024
• Est. primary completion date: February 26, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Nonpregnant women >18yo undergoing pelvic organ prolapse or urinary incontinence surgery

Exclusion Criteria:

• Patients undergoing fistula repair or sacral neuromodulation

• Voiding dysfunction preoperatively that requires intermittent self-catheterization

• Intraoperative bladder injury

• Pregnancy

• Preoperative UTI (culture proven within 7 days prior to surgery)

Related Conditions & MeSH terms

• Voiding Dysfunction

Intervention

Procedure:
• Control Group
Patients will be randomized to a 200mL (control group)
• Test Group
Patients will be randomized to a cut-off of 150mL (test group)

Locations

Country	Name	City	State
United States	Wake Forest University Health Sciences	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Wake Forest University Health Sciences

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	difference in acute voiding dysfunction between a backfill assisted voiding trial	difference in acute voiding dysfunction between a backfill assisted voiding trial with a volume voided cutoff of 150mL vs. 200mL for passage of VT - Acute voiding dysfunction is defined as a failed voiding trial requiring discharge home with a catheter, as well as voiding dysfunction occurring at a later time that results in an emergency department/urgent care/clinic visit requiring either an indwelling catheter or clean intermittent catheterization (CIC)	Week 6
Secondary	proportion of patients develops postoperative UTIs	UTI diagnosed by symptomatology alone or urinalysis (UA) + culture proven within one week (7 days) of catheter removal	Day 7
Secondary	proportion of patients developing overactive bladder symptoms	Sudden urge to urinate that is difficult to hold, with leakage of urine (even if you just voided recently), Frequent urination (>8 times/day), or waking up at night to urinate (2 or more times/night)	Week 6
Secondary	proportion of patients developing bladder pain or pressure	Bladder pain (pain or discomfort in the lower abdomen when your bladder is full) or bladder pressure (continuous feeling of pressure, not relieved by urination)	Week 6
Secondary	proportion of patients requiring repeat outpatient voiding trials	proportion of patients requiring repeat outpatient voiding trials	Week 6
Secondary	average number of days postoperatively, that require catheterization	average number of days postoperatively, that require catheterization	Week 6