Trial Outcomes & Findings for Timing of Repeat Voiding Trials After Outpatient Pelvic Floor Surgery (NCT NCT03048682)
NCT ID: NCT03048682
Last Updated: 2024-08-21
Results Overview
Determine the rates of failed voiding trials in each of the two groups
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
64 participants
Primary outcome timeframe
within 8 days of surgery
Results posted on
2024-08-21
Participant Flow
Participant milestones
| Measure |
Early Voiding Trial
All subjects that are discharged home with a Foley catheter will need an in-office repeat voiding trial.
Subjects in this group will have their repeat voiding trial on post-op day #2, 3, or 4
Foley catheter - Early Voiding Trial: All subjects that are discharged home with a Foley catheter will need an in-office repeat voiding trial.
Subjects in the Early Voiding group will have their repeat voiding trial on post-op day #2, 3, or 4 will undergo an in-office voiding trial. The experimental group will return for an in-office voiding trial sooner than the active comparator.
|
Late Voiding Trial
All subjects that are discharged home with a Foley catheter will need an in-office repeat voiding trial.
Subjects in this group will have their repeat voiding trial on post-op day #7 or after. This is our current practice.
Foley catheter - Late Voiding Trial: All subjects that are discharged home with a Foley catheter will need an in-office repeat voiding trial.
Subjects in the Late Voiding group will have their repeat voiding trial on post-op day #7 or after. This is our current practice
|
|---|---|---|
|
Overall Study
STARTED
|
32
|
32
|
|
Overall Study
COMPLETED
|
30
|
30
|
|
Overall Study
NOT COMPLETED
|
2
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Not all subjects underwent urodynamic testing.
Baseline characteristics by cohort
| Measure |
Early Voiding Trial
n=32 Participants
All subjects that are discharged home with a Foley catheter will need an in-office repeat voiding trial.
Subjects in this group will have their repeat voiding trial on post-op day #2, 3, or 4
Foley catheter - Early Voiding Trial: All subjects that are discharged home with a Foley catheter will need an in-office repeat voiding trial.
Subjects in the Early Voiding group will have their repeat voiding trial on post-op day #2, 3, or 4 will undergo an in-office voiding trial. The experimental group will return for an in-office voiding trial sooner than the active comparator.
|
Late Voiding Trial
n=32 Participants
All subjects that are discharged home with a Foley catheter will need an in-office repeat voiding trial.
Subjects in this group will have their repeat voiding trial on post-op day #7 or after. This is our current practice.
Foley catheter - Late Voiding Trial: All subjects that are discharged home with a Foley catheter will need an in-office repeat voiding trial.
Subjects in the Late Voiding group will have their repeat voiding trial on post-op day #7 or after. This is our current practice
|
Total
n=64 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
64.06 years
STANDARD_DEVIATION 12.04 • n=32 Participants
|
65.31 years
STANDARD_DEVIATION 11.45 • n=32 Participants
|
64.69 years
STANDARD_DEVIATION 11.67 • n=64 Participants
|
|
Sex: Female, Male
Female
|
32 Participants
n=32 Participants
|
32 Participants
n=32 Participants
|
64 Participants
n=64 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=32 Participants
|
0 Participants
n=32 Participants
|
0 Participants
n=64 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
23 participants
n=32 Participants
|
26 participants
n=32 Participants
|
49 participants
n=64 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
3 participants
n=32 Participants
|
5 participants
n=32 Participants
|
8 participants
n=64 Participants
|
|
Race/Ethnicity, Customized
African American
|
6 participants
n=32 Participants
|
1 participants
n=32 Participants
|
7 participants
n=64 Participants
|
|
Region of Enrollment
United States
|
32 participants
n=32 Participants
|
32 participants
n=32 Participants
|
64 participants
n=64 Participants
|
|
BMI
|
28.24 kg/m^2
STANDARD_DEVIATION 6.77 • n=32 Participants
|
26.34 kg/m^2
STANDARD_DEVIATION 5.23 • n=32 Participants
|
27.29 kg/m^2
STANDARD_DEVIATION 6.07 • n=64 Participants
|
|
Smoking status
Current
|
0 Participants
n=32 Participants
|
0 Participants
n=32 Participants
|
0 Participants
n=64 Participants
|
|
Smoking status
Former
|
4 Participants
n=32 Participants
|
5 Participants
n=32 Participants
|
9 Participants
n=64 Participants
|
|
Smoking status
Never
|
28 Participants
n=32 Participants
|
27 Participants
n=32 Participants
|
55 Participants
n=64 Participants
|
|
Postmenopausal
|
28 Participants
n=32 Participants
|
27 Participants
n=32 Participants
|
55 Participants
n=64 Participants
|
|
prior hysterectomy
|
8 Participants
n=32 Participants
|
9 Participants
n=32 Participants
|
17 Participants
n=64 Participants
|
|
POP-Q stage
POP- Q Stage II
|
15 Participants
n=32 Participants
|
10 Participants
n=32 Participants
|
25 Participants
n=64 Participants
|
|
POP-Q stage
POP- Q Stage III
|
15 Participants
n=32 Participants
|
21 Participants
n=32 Participants
|
36 Participants
n=64 Participants
|
|
POP-Q stage
POP-Q Stage IV
|
2 Participants
n=32 Participants
|
1 Participants
n=32 Participants
|
3 Participants
n=64 Participants
|
|
pre-operative post void residual
|
38.84 ml
STANDARD_DEVIATION 30.11 • n=32 Participants
|
38.94 ml
STANDARD_DEVIATION 39.62 • n=32 Participants
|
38.89 ml
STANDARD_DEVIATION 34.90 • n=64 Participants
|
|
Urodynamic diagnosed incontinence
None
|
14 Participants
n=28 Participants • Not all subjects underwent urodynamic testing.
|
14 Participants
n=29 Participants • Not all subjects underwent urodynamic testing.
|
28 Participants
n=57 Participants • Not all subjects underwent urodynamic testing.
|
|
Urodynamic diagnosed incontinence
SUI
|
11 Participants
n=28 Participants • Not all subjects underwent urodynamic testing.
|
9 Participants
n=29 Participants • Not all subjects underwent urodynamic testing.
|
20 Participants
n=57 Participants • Not all subjects underwent urodynamic testing.
|
|
Urodynamic diagnosed incontinence
ISD
|
2 Participants
n=28 Participants • Not all subjects underwent urodynamic testing.
|
3 Participants
n=29 Participants • Not all subjects underwent urodynamic testing.
|
5 Participants
n=57 Participants • Not all subjects underwent urodynamic testing.
|
|
Urodynamic diagnosed incontinence
DO
|
1 Participants
n=28 Participants • Not all subjects underwent urodynamic testing.
|
3 Participants
n=29 Participants • Not all subjects underwent urodynamic testing.
|
4 Participants
n=57 Participants • Not all subjects underwent urodynamic testing.
|
|
Concurrent vaginal hysterectomy
|
21 Participants
n=32 Participants
|
11 Participants
n=32 Participants
|
32 Participants
n=64 Participants
|
|
Apical Suspension
|
25 Participants
n=32 Participants
|
27 Participants
n=32 Participants
|
52 Participants
n=64 Participants
|
|
Type of Apical Suspension
Sacrospinous Fixation
|
10 Participants
n=25 Participants • Not all subjects underwent an apical suspension
|
14 Participants
n=27 Participants • Not all subjects underwent an apical suspension
|
24 Participants
n=52 Participants • Not all subjects underwent an apical suspension
|
|
Type of Apical Suspension
Uterosacral Suspension
|
15 Participants
n=25 Participants • Not all subjects underwent an apical suspension
|
13 Participants
n=27 Participants • Not all subjects underwent an apical suspension
|
28 Participants
n=52 Participants • Not all subjects underwent an apical suspension
|
|
Anterior Colporrhaphy
|
24 Participants
n=32 Participants
|
27 Participants
n=32 Participants
|
51 Participants
n=64 Participants
|
|
Posterior Colporrhaphy
|
30 Participants
n=32 Participants
|
32 Participants
n=32 Participants
|
62 Participants
n=64 Participants
|
|
Midurethral Sling
|
18 Participants
n=32 Participants
|
14 Participants
n=32 Participants
|
32 Participants
n=64 Participants
|
|
Vaginal Pack Used
|
15 Participants
n=32 Participants
|
13 Participants
n=32 Participants
|
28 Participants
n=64 Participants
|
|
Intra-operative Urine Dye
None
|
18 Participants
n=32 Participants
|
23 Participants
n=32 Participants
|
41 Participants
n=64 Participants
|
|
Intra-operative Urine Dye
Fluorescein
|
7 Participants
n=32 Participants
|
3 Participants
n=32 Participants
|
10 Participants
n=64 Participants
|
|
Intra-operative Urine Dye
Indigo Carmine
|
5 Participants
n=32 Participants
|
5 Participants
n=32 Participants
|
10 Participants
n=64 Participants
|
|
Intra-operative Urine Dye
Phenazopyridine
|
2 Participants
n=32 Participants
|
1 Participants
n=32 Participants
|
3 Participants
n=64 Participants
|
|
Intra-operative use of Furosemide
|
4 Participants
n=32 Participants
|
5 Participants
n=32 Participants
|
9 Participants
n=64 Participants
|
|
Anesthesia
General
|
31 Participants
n=32 Participants
|
32 Participants
n=32 Participants
|
63 Participants
n=64 Participants
|
|
Anesthesia
Spinal
|
1 Participants
n=32 Participants
|
0 Participants
n=32 Participants
|
1 Participants
n=64 Participants
|
|
Total Morphine Dose Equivalents
|
21.45 morphine dose equivalents
STANDARD_DEVIATION 11.85 • n=32 Participants
|
18.67 morphine dose equivalents
STANDARD_DEVIATION 8.72 • n=32 Participants
|
20.06 morphine dose equivalents
STANDARD_DEVIATION 10.41 • n=64 Participants
|
PRIMARY outcome
Timeframe: within 8 days of surgeryDetermine the rates of failed voiding trials in each of the two groups
Outcome measures
| Measure |
Early Voiding Trial
n=30 Participants
All subjects that are discharged home with a Foley catheter will need an in-office repeat voiding trial.
Subjects in this group will have their repeat voiding trial on post-op day #2, 3, or 4
Foley catheter - Early Voiding Trial: All subjects that are discharged home with a Foley catheter will need an in-office repeat voiding trial.
Subjects in the Early Voiding group will have their repeat voiding trial on post-op day #2, 3, or 4 will undergo an in-office voiding trial. The experimental group will return for an in-office voiding trial sooner than the active comparator.
|
Late Voiding Trial
n=30 Participants
All subjects that are discharged home with a Foley catheter will need an in-office repeat voiding trial.
Subjects in this group will have their repeat voiding trial on post-op day #7 or after. This is our current practice.
Foley catheter - Late Voiding Trial: All subjects that are discharged home with a Foley catheter will need an in-office repeat voiding trial.
Subjects in the Late Voiding group will have their repeat voiding trial on post-op day #7 or after. This is our current practice
|
|---|---|---|
|
Failed Office Voiding Trials
|
7 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: within 6 weeks of surgeryDetermine the rates of urinary tract infections in each of the two groups
Outcome measures
| Measure |
Early Voiding Trial
n=30 Participants
All subjects that are discharged home with a Foley catheter will need an in-office repeat voiding trial.
Subjects in this group will have their repeat voiding trial on post-op day #2, 3, or 4
Foley catheter - Early Voiding Trial: All subjects that are discharged home with a Foley catheter will need an in-office repeat voiding trial.
Subjects in the Early Voiding group will have their repeat voiding trial on post-op day #2, 3, or 4 will undergo an in-office voiding trial. The experimental group will return for an in-office voiding trial sooner than the active comparator.
|
Late Voiding Trial
n=30 Participants
All subjects that are discharged home with a Foley catheter will need an in-office repeat voiding trial.
Subjects in this group will have their repeat voiding trial on post-op day #7 or after. This is our current practice.
Foley catheter - Late Voiding Trial: All subjects that are discharged home with a Foley catheter will need an in-office repeat voiding trial.
Subjects in the Late Voiding group will have their repeat voiding trial on post-op day #7 or after. This is our current practice
|
|---|---|---|
|
Urinary Tract Infections
|
7 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: within 6 weeks of surgeryDetermine the rates of patient satisfaction in each of the two groups using a Likert scale (1= very bothersome; 5= Not bothersome at all)
Outcome measures
| Measure |
Early Voiding Trial
n=30 Participants
All subjects that are discharged home with a Foley catheter will need an in-office repeat voiding trial.
Subjects in this group will have their repeat voiding trial on post-op day #2, 3, or 4
Foley catheter - Early Voiding Trial: All subjects that are discharged home with a Foley catheter will need an in-office repeat voiding trial.
Subjects in the Early Voiding group will have their repeat voiding trial on post-op day #2, 3, or 4 will undergo an in-office voiding trial. The experimental group will return for an in-office voiding trial sooner than the active comparator.
|
Late Voiding Trial
n=30 Participants
All subjects that are discharged home with a Foley catheter will need an in-office repeat voiding trial.
Subjects in this group will have their repeat voiding trial on post-op day #7 or after. This is our current practice.
Foley catheter - Late Voiding Trial: All subjects that are discharged home with a Foley catheter will need an in-office repeat voiding trial.
Subjects in the Late Voiding group will have their repeat voiding trial on post-op day #7 or after. This is our current practice
|
|---|---|---|
|
Rate of Bother From Urinary Catheter
|
3 score on a scale
Interval 1.0 to 3.5
|
2 score on a scale
Interval 1.0 to 3.0
|
Adverse Events
Early Voiding Trial
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Late Voiding Trial
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place