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N/A N=84 Randomized Prevention

Urinary Retention After Total Laparoscopic Hysterectomy With Immediate Foley Catheter Removal Versus Backfill Void Trial

Urinary Retention · Voiding Disorders

Enrolled (actual)
84
Serious AEs
0.0%
Results posted
Oct 2018
Primary outcome: Primary: Number of Participants With Void Trial Failure Rate — 7; 11 Participants

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
Void Trial using Foley catheter (Device)
Age
Adult, Older Adult · 18+ yrs
Sex
Female
Sponsor
Sara Farag
Primary completion
Apr 2018

Outcome Measures

OutcomeResultp-value
PRIMARY
Number of Participants With Void Trial Failure Rate
7; 11
SECONDARY
Time to Discharge
176; 218
SECONDARY
Number of Patients With Urinary Retention
1; 1
SECONDARY
Number of Participants With Post-Operative Urinary Tract Infection
2; 1
SECONDARY
Quality of Bladder Function Using the Incontinence Impact Questionnaire
0; 0
SECONDARY
Patient Perception of Bladder Condition Score
0; 0
SECONDARY
Number of Participants Satisfied or Very Satisfied With Void Trial Using 5 Point Lickert Scale
39; 30

Summary

Acute urinary retention is a complication of hysterectomies that can result in bladder over-distension and long term bladder dysfunction. The incidence of acute urinary retention after total laparoscopic hysterectomy (TLH) has been reported to be anywhere between 4% and 34%. Studies have varied in the method of post-operative bladder challenge and the modality of hysterectomy included. Moreover, most of the published studies are retrospective chart reviews or prospective observational studies, with a lack of randomized controlled trials. Risk factors for urinary retention include type of anesthesia used, how the hysterectomy is performed, use of post-operative narcotics, pre-operative urinary retention, and possibly aggressive bladder dissection. With the increased trend towards same-day discharge following TLH, urinary retention may cause unnecessary patient distress and a worsened post-operative course. Standardization of post-hysterectomy bladder challenge and identification of risk factors for urinary retention may aid in preventing urinary retention or acute bladder dysfunction. The primary objective is to compare the rate of void trial failure after TLH with the backfill technique versus the autofill technique.

Eligibility Criteria

Inclusion Criteria

  • Females at least 18 years of age
  • Understand and voluntarily sign an informed consent form
  • English-speaking (able to read and understand English)
  • Undergoing total laparoscopic hysterectomy for benign indication

Exclusion Criteria

  • Undergoing concomitant procedures in addition to hysterectomy which may cause urinary dysfunction
  • Undergoing robotic-assisted laparoscopy or laparotomy
  • Known history of pre-operative urinary incontinence or retention
  • History of prior bladder or prolapse surgery
  • Neurologic or spinal cord injury affecting bladder function
  • Pregnant women
  • Evidence of gynecologic malignancy
  • Currently taking anticholinergic medications
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03141372). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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