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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT02739256
Other study ID # PRO15100653
Secondary ID
Status Terminated
Phase N/A
First received
Last updated
Start date February 2016
Est. completion date March 1, 2017

Study information

Verified date June 2018
Source University of Pittsburgh
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Terminated
Enrollment 57
Est. completion date March 1, 2017
Est. primary completion date March 1, 2017
Accepts healthy volunteers No
Gender Female
Age group 21 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Retrograde voiding trial
A bladder test is performed after surgery for prolapse to make sure the patient can empty their bladder prior to discharge from the hospital. The test consists of filling the bladder with 300 mL of water and removing the catheter. Then the patient voids.

Locations

Country Name City State
United States Magee Women's Hospital of UPMC Pittsburgh Pennsylvania

Sponsors (1)

Lead Sponsor Collaborator
University of Pittsburgh

Country where clinical trial is conducted

United States, 

References & Publications (3)

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):637-42. doi: 10.1097/AOG.0b0 — View 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. — View 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary time to return of normal bladder function 5 days
Secondary time to first ambulation 24 hours
Secondary anxiety level The State-Trait Anxiety Index anxiety inventory will be administered pre-operatively and at 4 different time point post-operatively to assess the patient's level of anxiety related to the catheter 24 hours
Secondary pain level A pain scale will be administered pre-operatively and at 4 different time point post-operatively to assess the patient's level of anxiety related to the catheter 24 hours
Secondary patient preference in the timing of the voiding trial a brief survey will be given 4 times during the hospital admission assess this 24 hours
Secondary catheter associated urinary tract infections medical records will be reviewed after discharge from the hospital for positive urine cultures 6 weeks
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