Is Self-discontinuation of a Transurethral Catheter Following Pelvic Reconstructive Surgery as Effective as Office-based Discontinuation?; A Randomized Controlled Trial
Phase: NA
Conditions: Postoperative Urinary Retention
Sponsor: TriHealth Inc.

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Date 
7-26-2018 
Title 
Is Self-discontinuation of a transurethral catheter following pelvic 
reconstructive surgery as effective as office-based discontinuation?; 
A Randomized Controlled Trial 
Principal Investigator 
Rachel N. Pauls, MD 
Sub-Investigators 
Abigail Shatkin-Margolis, MD; Steven D. Kleeman, MD; Catrina C. 
Crisp, MD MSc; Jennifer Yeung, DO; Austin Hill, MD, Tiffanie Tam, 
MD 
Research Specialist 
Eunsun Yook, MS 
Department 
Department of OB/Gyn, Division of Urogynecology and 
Reconstructive Pelvic Surgery 
Hatton # 
16-075 
 
Purpose of Study:  
 To determine if self-discontinuation of transurethral foley catheters in patients 
diagnosed with postoperative urinary retention (POUR) following inpatient pelvic 
organ prolapse surgery is non-inferior to office-discontinuation.  
o Primary Aim: To determine the incidence of POUR (as defined as the continued 
need for catheterization) at postoperative day 6-8 (POD6-8) following inpatient 
pelvic organ prolapse surgery in patients who self-discontinue their indwelling 
urinary catheter compared to those who present to the office for 
discontinuation.  
o Secondary Aims: To compare patient satisfaction, number of patient related 
encounters (emergency room, office visit, or telephone calls), incidence of 
postoperative urinary tract infection (UTI), post void residual volume (PVR) at 2-
week postoperative visit, and total duration of catheter use between the two 
groups. 
  
Hypothesis or Research Question  
 We hypothesize that self-removal of indwelling urinary catheters will be non-inferior 
to office-removal on POD6-8 regarding ongoing symptoms of POUR following 
inpatient pelvic organ prolapse surgery. 
 We further hypothesize that self-removal of indwelling urinary catheters will result 
in fewer office visits and improved patient satisfaction in the immediate 
postoperative period. 
 In addition, we hypothesize that the duration of POUR (number of days urinary 
catheter use is required) will be equivalent in the self-removal group compared to 
that of the office-removal group. 
 Lastly, we hypothesize that there will be less incidence of UTI in the self-removal 
group.  
 
Background  
Postoperative urinary retention (POUR) is a common issue following urogynecologic surgery, 
with incidence rates of 1.4-43% [1-5]. The wide range of incidence is due to the lack of a 

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standardized definition of POUR. Generally speaking, POUR can be characterized by any 
impairment in bladder emptying following surgery. While the gold standard for assessing 
voiding function remains measurement of a postvoid residual (PVR), there are many voiding 
trial (VT) methods being used across institutions [6].  In our clinical practice, rates of POUR 
following pelvic reconstructive surgery are approximately 54% [7].  These patients are provided 
an indwelling transurethral foley catheter to remain in place for approximately one week, at 
which time they are seen in the office for a subsequent voiding challenge. The incidence of 
POUR, and continued need for indwelling urinary catheter, at one-week postoperative is 
approximately 16% (review of prior data from pooled studies of our patients). 
 
Historically, the most widely accepted postoperative VT for the assessment of voiding function 
was the backfill method. This method consists of retrograde-filling the bladder through the 
patients foley catheter with 300 mL sterile normal saline (or maximum capacity, if sooner), 
removing the indwelling urinary catheter, and allowing the patient to void. A voided volume of 
at least 200 mL (or two-thirds of the instilled volume) is considered passing, and correlates with 
adequate bladder function. An alternative assessment of voiding function is the spontaneous 
VT, where the indwelling catheter is removed and a patient is asked to void spontaneously 
when she has the urge. A PVR is then measured, either by way of ultrasound or with in-and-out 
catheterization.  
 
It is controversial which of these methods are superior, and studies are conflicted.  In a 
comparison of backfill VT versus spontaneous VT in patients undergoing outpatient 
urogynecologic surgery, the backfill method was superior in ‘passing’ rates [8]. However, a 
recent retrospective study of 1153 patients following urogynecologic surgery showed that 
backfill VT was associated with an increased rate of urinary tract infections and higher failed 
trial of void [9]. Furthermore, patient satisfaction does not differ between the two types of VT 
performed [8].  Nevertheless, both of these methods were studied in a clinical setting, and we 
lack information on self-discontinuation efficacy at home. 
 
What is evident in all research is that evaluation and management of POUR can be 
cumbersome, and highly concerning to patients. Patients with indwelling urinary catheters 
often feel anxiety, embarrassment, and loss of dignity. Furthermore, it has been shown that 
patients would prefer to be more involved in the decisions around catheter use [10]. Managing 
an indwelling urinary catheter and returning to the outpatient clinic only a week after discharge 
from the hospital can be overwhelming for patients and their involved caregivers.  
 
Review of the literature reveals no studies to date regarding self-removal of indwelling urinary 
catheters. Given the low incidence of POUR at one-week postoperative and patient 
dissatisfaction with urinary catheter management, home self-removal of indwelling urinary 
catheters is an important topic of investigation. We aim to fill this knowledge gap by 
determining the incidence of POUR at POD6-8 with self-removal of indwelling urinary catheters 
compared to office-removal in the setting of inpatient pelvic organ prolapse surgery. 
Furthermore, we aim to compare patient satisfaction with self-removal versus office-removal, 
as previous publications suggest that patients may feel empowered by being more involved in 
the management of their urinary catheter [10]. If self-removal proves to be non-inferior to 

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office-removal, this would be a new, efficient and potentially cost-effective management option 
for POUR.   
 
Research Plan  
 Study Design  
o Randomized controlled trial 
o Non-inferiority trial 
 Setting for the study 
o Patients of Cincinnati Urogynecology Associates, TriHealth Inc, undergoing 
inpatient surgery for pelvic organ prolapse at Good Samaritan Hospital or 
Bethesda North Hospital who fail their voiding trial will be offered enrollment. 
o Those patients who choose to enroll in the study will be provided with a sealed 
envelope that will dictate to which group the patient has been randomized. 
o Those patients randomized to the self-removal group will be provided with a 
diagrammatic handout, illustrating proper removal of their catheter. They will be 
instructed to remove their indwelling urinary catheter at home on the morning 
of POD7. They will also be provided with the direct phone number of our 
Research Nurse and the pager number of our on-call staff, which they will use to 
contact the team if they are unable to void within 5 hours of catheter removal. If 
they are unable to void, the Research Nurse or on-call staff will arrange a clinic 
visit for the same day at one of three outpatient clinics (Clifton, West Chester, 
Kenwood) for replacement of an indwelling urinary catheter. 
o Those patients randomized to the office-removal group will schedule an office 
visit for POD6-8 at one of three outpatient clinics (Clifton, West Chester, 
Kenwood). At this visit the patient will undergo a backfill VT.  
o All patients will present to one of three outpatient clinics (Clifton, West Chester, 
Kenwood) at two weeks postoperative for a routine postoperative evaluation, 
measurement of PVR, urine dip, and completion of the patient questionnaire. 
o All patients will present to one of three outpatient clinics (Clifton, West Chester, 
Kenwood) at six weeks postoperative for a routine postoperative evaluation and 
urine dip. 
 Participants  
o Study population: All women 18 years of age or older, who undergo vaginal vault 
suspension or robot-assisted laparoscopic sacrocolpopexy, with or without 
additional concomitant procedures by a physician at Cincinnati Urogynecology 
Associates, TriHealth for treatment of pelvic organ prolapse (POP) and who fail 
their VT prior to discharge will be approached for recruitment. 
o Inclusion/Exclusion criteria: 

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 Inclusion 
 Adults 18 years of age or older 
 Undergoing vaginal vault suspension or robot-assisted 
laparoscopic sacrocolpopexy by a physician at Cincinnati 
Urogynecology Associates, TriHealth for the treatment of POP 
 Concomitant procedures such as hysterectomy, suburethral sling, 
anterior or posterior colporrhaphy, bilateral salpingectomy or 
salpingooophorectomy 
 Failed voiding trial prior to discharge 
 Exclusion 
 Unwillingness to participate in the study 
 Physical or mental impairment that would affect the subject’s 
ability to self-remove indwelling urinary catheter, including 
patient’s with Multiple Sclerosis, Dementia, Parkinsonism, or 
those who have impaired mobility or are wheelchair bound 
 Bladder injury, fistula repair or other need for prolonged 
catheterization 
o Sample size 
 A sample size was calculated to be 74 patients in each arm based on the 
following:  
 The estimated POUR requiring indwelling urinary catheter at 7 
days postoperative is 16% (based on internal audit of data) 
 The non-inferiority margin was set at 15%. [11] 
 The power was set at 80%.  
 Due to estimated loss-to-follow-up rate of approximately 13%, the 
number of patient enrollment was set at 84 subjects in each 
group, 168 total. 
 Data Collection 
o Primary outcome: 
 POUR at POD6-8 as defined by need for continued indwelling urinary 
catheter or intermittent self-catheterization.  
 Continued indwelling urinary catheter will be required in the following 
settings: 
 Self-removal group – inability to void or sense of incomplete 
bladder emptying after 5 hours of catheter removal  
 Office-removal group – voided volume less than two-thirds of the 
instilled volume or PVR greater than 100mL after backfill of up to 
300mL 

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o Secondary outcomes 
 Scores on patient questionnaire collected at the two-week postoperative 
visit [12,13] (Patient Questionnaire and Visual Analog Scale) 
 Number of patient contact points (office visits, telephone calls and 
emergency room visits) regarding POUR or indwelling urinary catheter 
care up to 2 weeks postoperative.  
 PVR measurement at 2-week postoperative visit. 
 UTI diagnosed within 6 weeks postoperative (as defined by positive urine 
culture, or treatment with antibiotics by a provider). 
 Total duration (number of days) of urinary catheter use (including 
indwelling urinary catheter and intermittent self catheterization) within 6 
weeks postoperative. 
o General demographic data 
 Name, date of birth, age, race, weight, height, BMI, parity, tobacco use, 
medical comorbidities, date of surgery 
o Data collection tool 
 Intervention or experimental aspect of the study 
o Procedure 
 All patients of Cincinnati Urogynecology Associates who undergo vaginal 
vault suspension (VVS) or robot-assisted laparoscopic sacrocolpopexy 
(RSCP) will have a backfill VT on POD1 at 6am, per standard practice. The 
backfill VT will be performed by the nursing staff. Per protocol, up to 
300ml sterile saline will be instilled into the bladder and the indwelling 
urinary catheter will be removed. Patients will be allotted 30 minutes to 
void. The instilled volume, voided volume , and PVR if needed will be 
recorded. 
 Failure of backfill VT is defined by inability to void two-thirds of the 
instilled volume or PVR greater than 100mL. 
 Patients who fail the backfill VT postoperatively  will have an indwelling 
urinary catheter reinserted and will be taught on its use by nursing staff.  
They will be approached for possible study enrollment by one of the 
study investigators. 
 If a patient agrees to participate in the study, she will receive a sealed 
envelope dictating to which group she will be randomized. 
 All subjects will be provided prescriptions for pain medication, bowel 
regimen, and cranberry supplements, per standard practice. 

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 Number of contact points (office visits, emergency room visits, and 
phone calls to care team) will be recorded during the first two weeks 
postoperative. 
 
o Self-removal group 
 They will be provided with a diagrammatic handout, illustrating proper 
removal of their catheter (Diagram for Self-Removal)  
 They will be instructed to remove their indwelling urinary catheter at 
home on the morning of POD7 at approximately 7am.  
 They will be provided with the phone number of the Research Nurse and 
the pager number of the on-call staff. 
 On POD6 evening or POD7 morning, the Research Nurse will contact each 
patient to remind patients of the plan and review proper self-catheter 
removal. 
 On POD7 they will discontinue their indwelling urinary catheter by way of 
the instructions provided.  
 If they are UNABLE to void within 5 hours of catheter removal or have 
feelings of incomplete bladder emptying, they will call the Research 
Nurse or page the on-call staff. The Research Nurse or on-call staff will 
arrange a clinic visit for the same day at one of three outpatient clinics 
(Clifton, West Chester, Kenwood) for replacement of an indwelling 
urinary catheter.  
 A urine dip will be performed on the urine collected via the 
catheter. If positive for leukocyte esterase, white blood cells, or 
nitrites, the urine sample will be sent to the laboratory for culture 
 All urine culture results will be reviewed and if positive, will be 
treated and recorded. They will return to home with an indwelling 
urinary catheter and represent to the office for their two-week 
postoperative visit. 
 If they are ABLE to void within 5 hours of self-removal, they will remain 
without a catheter and present for their routine two-week postoperative 
visit the following week. 
 
o Office-removal group 
 They will call the office to schedule a repeat VT visit on POD6-8 (POD7 
will be encouraged). 
 They will have a backfill VT (as described above). 
 If they are UNABLE to void two-thirds of the instilled volume or have a 
PVR greater than 100ml, they will have an indwelling urinary catheter 

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reinserted at that time. They will return to home with an indwelling 
urinary catheter and represent to the office for their routine two-week 
postoperative visit. 
 If they are ABLE to void two-thirds of the instilled volume, they will 
remain without a catheter and present for their routine two-week 
postoperative visit the following week. 
 A urine dip will be performed on the foley catheter urine sample prior to 
the initiation of the backfill VT. If positive for leukocyte esterase, white 
blood cells, or nitrites, the urine dip will be sent to the laboratory for 
culture. All urine culture results will be reviewed and if positive, will be 
treated and recorded. 
 
o Two-week postoperative visit 
 All patients will present to the office for routine two-week postoperative 
visit. 
 Those patients who have an indwelling urinary catheter in place at this 
time will have a backfill VT performed (as described above). 
 If they are UNABLE to void two-thirds of the instilled volume or 
have a PVR greater than 100ml, they will either have an indwelling 
urinary catheter replaced or be taught intermittent self-
catheterization. They will have follow-up per standard office 
practice. 
 If they are ABLE to void two-thirds of the instilled volume, they 
will remain without a catheter and present for their routine six-
week postoperative visit. 
 All patients will have a PVR measured and recorded. 
 All patients will have a urine dip performed (either from a voided urine 
sample or foley catheter urine sample) at their two-week postoperative 
visit. If positive for leukocyte esterase, white blood cells, or nitrites, the 
urine dip will be sent to the laboratory for culture. All urine culture 
results will be reviewed and if positive, will be treated and recorded. 
 All patients will complete the patient satisfaction questionnaire and VAS 
at their two-week postoperative visit (Patient Questionnaire and Visual 
Analog Scale) 
 
 Six-week postoperative visitAll patients will present to the office for  
routine six-week postoperative visit. 
 All patients will have a urine dip performed at their six-week 
postoperative visit. If positive for leukocyte esterase, white blood cells, or 

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nitrites, the urine dip will be sent to the laboratory for culture. All urine 
culture results will be reviewed and if positive, will be treated and 
recorded. 
 Total duration of catheter use (indwelling urinary catheter or intermittent 
self-catheterization) will be extracted from the patients’ chart and 
recorded at this time. 
 
Statistical Analysis 
o Descriptive statistics will be generated for demographic information such as age, 
race, BMI, Parity etc. The OR and 95% CI’s of OR will be utilized to compare our 
primary outcome, the incidence of POUR between the two groups (self-removal 
and office-removal). Continuous variables such as the patient satisfaction 
questionnaire on VAS will be analyzed using independent samples t-tests or 
Mann-Whitney U test for significant difference between groups. Categorical 
variables will be tested using the Fisher’s exact or Pearson Chi-square tests.    
Ethical Considerations 
 Informed consent  
o Patients who agree to participate in the study will sign a written informed 
consent. They will be consented by one of the stated investigators or trained 
Research Nurse and they will receive a copy of the signed informed consent 
statements (ICS). A copy will be put in their medical file. 
 Privacy information 
o Extensive efforts will be made to ensure and maintain participant 
confidentiality. All identifying information will be maintained in a secure area 
at all times. Source documentation will be maintained in a separate folder. 
When documentation has to be made available for data analysis, copies of 
the source (Excel spreadsheets) with only Subject ID number visible and 
personal information obscured will be used. All communication between 
staff members regarding participant data will occur via the Subject ID 
number only. However, identifying information will be retained in the 
original/source documents. 
o The participant will be logged in the Excel spreadsheet and assigned a 
Subject ID number. Each participant will be assigned the next available 
Subject ID number. Once each Subject ID number has been assigned, it will 
not be reassigned. The Excel spreadsheet will be stored on a password 

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protected, encrypted TriHealth computer for ten years following study 
closure, and then purged. 
Cost/Budget 
 
Item 
Amount 
Qty 
Total 
Patient stipend for visit (mileage, time for travel, 
questionnaire completion, etc) 
$25.00 
168 
$4,200.00 
 
Estimated Period of time to complete study:  
 
Estimated Period of Time to Complete Study 
When will study begin? 
1/01/2017 
Protocol Development 
Completed 
4 weeks 
Admin Review Time 
2 weeks 
IRB Approval 
6 weeks 
Data collection 
18 months 
Data analysis 
2 months 
Presentation development 
(if applicable) 
3 weeks 
Manuscript Development 
(if applicable) 
4 weeks 
Journal submission process 
(if applicable) 
2 months 
Study closure 
2 weeks 
 
 When and how will results be disseminated? 
o We plan for the results to be disseminated in Spring 2019 at a national 
meeting in the form of a poster or oral presentation. We also plan for the 
results to be published. 
 
References 
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comparing 3 hour and 24 hour postoperative removal of bladder catheter and vaginal 
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