N/A
N=84
Urinary Retention After Total Laparoscopic Hysterectomy With Immediate Foley Catheter Removal Versus Backfill Void Trial
Urinary Retention · Voiding Disorders
Bottom Line
View on ClinicalTrials.gov: NCT03141372 ↗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
| Outcome | Result | p-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
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.