Urinary Retention Clinical Trial
Official title:
Urinary Retention Rates After Immediate Removal of Foley Catheter Versus Backfill Void Trial Following Total Laparoscopic Hysterectomy: A Randomized Controlled Trial
NCT number | NCT03141372 |
Other study ID # | FLA 17-020 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | May 16, 2017 |
Est. completion date | April 30, 2018 |
Verified date | October 2018 |
Source | The Cleveland Clinic |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 84 |
Est. completion date | April 30, 2018 |
Est. primary completion date | April 30, 2018 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
United States | Cleveland Clinic Florida | Weston | Florida |
Lead Sponsor | Collaborator |
---|---|
Sara Farag |
United States,
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Kandadai P, Saini J, Patterson D, O'Dell K, Flynn M. Urinary Retention After Hysterectomy and Postoperative Analgesic Use. Female Pelvic Med Reconstr Surg. 2015 Sep-Oct;21(5):257-62. doi: 10.1097/SPV.0000000000000151. — View Citation
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* Note: There are 21 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of Participants With Void Trial Failure Rate | The primary endpoint of this study will be to determine if the rate of void trial failure after total laparoscopic hysterectomy is different after the autofill method versus the backfill method. | post-operative day, about 4 hours post-surgery | |
Secondary | Time to Discharge | The time to discharge will be measured for each participant. This will be determined by calculating the time between arrival to the post-anesthesia care unit and the time of discharge using documentation from Epic and from the case report forms. | post-operative day, about 4 hours post-surgery | |
Secondary | Number of Patients With Urinary Retention | After discharge, participants will be monitored for any encounters for urinary retention (in our hospital system) and will be asked at their 10-14 day post-operative visit if they had a Foley catheter placed outside the hospital. Additionally, any participant who fails their 2nd void trial will be noted. The incidence of urinary retention post-discharge will be determined using this data. | 10-14 days post-surgery | |
Secondary | Number of Participants With Post-Operative Urinary Tract Infection | Any participant diagnosed with a culture-proven urinary tract infection will be noted. | up to 14 days post-surgery | |
Secondary | Quality of Bladder Function Using the Incontinence Impact Questionnaire | The Incontinence Impact Questionnaire-7 will be used to determine if there are any changes to the participants' short term quality of life before and after surgery. The questionnaire includes 7 questions asking how the participant's bladder function has affected her: Ability to do household chores. Physical recreation Entertainment activities Ability to travel by car or bus more than 30 minutes from home Participation in social activities outside the home Emotional health Feeling frustrated The patient scores each of the questions using the following scale: 0 - Not at all - Slightly - Moderately - Greatly The scores were added and divided by 7 to obtain an average score for each participant. Hence the range of scores is 0 to 3 with 0 being the best and 3 being the worst. |
pre-surgery and 14 days post-surgery | |
Secondary | Patient Perception of Bladder Condition Score | The Patient Perception of Bladder Condition will be used to determine if there are any changes to the participants' perception of bladder function before and after surgery. In this questionnaire, the participant answers one question as follows: My bladder condition: 0 - Does not cause me any problems at all - Causes me very minor problems - Causes me some minor problems - Causes me (some) moderate problems - Causes me severe problems - Causes me many severe problems The score was recorded for each patient. The range of possible scores were 0 to 5 with 0 being the best and 5 being the worst scores. |
presurgery and at 10-14 days post-surgery | |
Secondary | Number of Participants Satisfied or Very Satisfied With Void Trial Using 5 Point Lickert Scale | Participant satisfaction level with the method of void trial will be collected at the 10-14 day post-operative visit and compared between the two methods of void trial. | at 10-14 days post-surgery |
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