Clinical trial NCT02739256: Early Versus Late Voiding Trials After Prolapse Repair
Official title: Normal Voiding Function After Surgical Repair of Pelvic Organ Prolapse: A Randomized Trial Comparing Day of Surgery Retrograde Void Trials to Standard Postoperative Day One Retrograde Void Trials
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Urinary Retention
Pelvic Organ Prolapse
Keywords: voiding trial
pelvic organ prolapse
post-operative catheterization
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
First posted: 2016-04-15
Enrollment: 57
Sex: FEMALE
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: The primary aim of this study is to determine if normal bladder function (the ability to empty the bladder during spontaneous urination) after surgical repair of pelvic organ prolapse returns faster in patients who have a retrograde voiding trial the day of surgery versus patients who have a retrograde voiding trial on postoperative day one. Half of participants will have a voiding trial 4 hours after surgery, while the other half will have the voiding trial postoperative day one.

Detailed description: Overnight indwelling catheterization is a prevalent practice after surgical repair of pelvic organ prolapse. A voiding trial is performed postoperative day one to determine if urinary retention or abnormal bladder function exists. A significant number of patients ranging from 26-47% will require continued catheterization post-op for urinary retention in order to avoid injuries associated with over distention of the bladder and ureteral reflux.

This study aims to explore a strategy to reduce the length of catheterization post-operatively by testing the bladder at a closer interval to surgery. An earlier voiding trial may improve patient perioperative satisfaction and decrease catheter associated urinary tract infections. Additional benefits that may also be seen are earlier first ambulation and quicker achievement of post-op discharge milestones (pain control, ambulation with symptoms, oral intake tolerance and completion of a voiding trial). To date, few studies have attempted a day of surgery voiding trial in patients being admitted for repair of pelvic organ prolapse that requires an overnight admission.

Eligibility criteria: Inclusion Criteria:

* surgical management of pelvic organ prolapse requiring an overnight hospital admission

Exclusion Criteria:

* same day surgery
* non-ambulatory (allowed to use an assistive device)
* inability to provide informed consent, age \< 21 years
* pregnancy or desire for future pregnancy
* systematic disease known to affect bladder function (Parkinson's disease, Multiple Sclerosis, Spina Bifida, spinal cord injury or trauma and neurogenic bladder)
* known preoperative urinary retention (defined as a post-void residual \> 100mL)
* an untreated urinary tract infection at the time of surgery
* treatment at the time of surgery for urinary tract infection
* symptoms of urinary tract infection on the day of surgery

Primary outcomes:
measure: time to return of normal bladder function
timeFrame: 5 days
Secondary outcomes:
measure: time to first ambulation
timeFrame: 24 hours
measure: anxiety level
timeFrame: 24 hours
measure: pain level
timeFrame: 24 hours
measure: patient preference in the timing of the voiding trial
timeFrame: 24 hours
measure: catheter associated urinary tract infections
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: Magee Women's Hospital of UPMC
state: Pennsylvania
Study officials:
affiliation: Urogynecology Fellow
name: Charelle Carter-Brooks, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Oliphant SS, Lowder JL, Ghetti C, Zyczynski HM. Effect of a preoperative self-catheterization video on anxiety: a randomized controlled trial. Int Urogynecol J. 2013 Mar;24(3):419-24. doi: 10.1007/s00192-012-1868-y. Epub 2012 Jul 3.
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.
citation: Turner LC, Kantartzis K, Shepherd JP. Predictors of postoperative acute urinary retention in women undergoing minimally invasive sacral colpopexy. Female Pelvic Med Reconstr Surg. 2015 Jan-Feb;21(1):39-42. doi: 10.1097/SPV.0000000000000110.
citation: Ellahi A, Stewart F, Kidd EA, Griffiths R, Fernandez R, Omar MI. Strategies for the removal of short-term indwelling urethral catheters in adults. Cochrane Database Syst Rev. 2021 Jun 29;6(6):CD004011. doi: 10.1002/14651858.CD004011.pub4.