Trial Outcomes & Findings for Comparing Force of Stream to Retrograde Fill Voiding Trial After Vaginal Apex Suspension (NCT NCT02753920)
NCT ID: NCT02753920
Last Updated: 2018-11-05
Results Overview
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
184 participants
Primary outcome timeframe
6 weeks
Results posted on
2018-11-05
Participant Flow
After signing informed consent and enrolling in the study, 4 subjects withdrew consent prior to randomization, 4 subjects had surgery cancelled for various medical reasons, 3 subjects had cystotomies thus requiring prolonged catheterization for 1-2 weeks and 1 subject withdrew after randomization.
Participant milestones
| Measure |
Retrograde Fill Voiding Trial Method
Bladder drained w/ indwelling foley catheter, then retrograde filled w/ 300cc sterile water. Catheter is removed. Patient voids w/in 20 min (if unable to void after 20 minutes, she will be discharged home with a catheter secondary to voiding dysfunction). Patient subjectively quantify their force of stream via visual analog scale (VAS) scale (however this information will only be used for research purposes). If she voids \>/= 2/3 (200cc) the catheter will remain out as she will have passed her voiding trial. If she voids \<200cc she will be discharged home with a catheter and instructed to follow-up in 2-5 days for an in-office retrograde voiding trial.
TOV (trial of void): 1 of 2 tests to assess bladder function after vaginal apex suspension surgery with or without mid-urethral sling. catheter: If subject unable to void adequately, a Foley catheter will be placed as per protocol and the subject discharged home with catheter.
|
Force of Stream (FAST) Voiding Trial Method
Bladder drained w/ indwelling foley catheter, then retrograde filled w/ 300cc sterile water. Catheter is removed. Patient voids w/in 20 minutes (if unable to void after 20 minutes, discharged home w/ a catheter secondary to voiding dysfunction). The patient will subjectively quantify their force of stream via VAS scale. If VAS scale \>/=50 (\>/=50%) the catheter will remain out, patient is discharged home without measuring a PVR (postvoid residual). If VAS scale is from 0-49 (=0-49%) a PVR will be checked via bladder scan. If PVR is \<500cc, the patient will be discharged without a catheter; if PVR is \>/=500cc, the patient will be discharged with a catheter. If she is discharged with an indwelling foley catheter, she will have an in-office retrograde voiding trial in 2-5 days TOV: 1 of 2 tests to assess bladder function after vaginal apex suspension surgery with or without mid-urethral sling catheter: If subject is unable to void adequately
|
|---|---|---|
|
Overall Study
STARTED
|
87
|
86
|
|
Overall Study
COMPLETED
|
87
|
86
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Comparing Force of Stream to Retrograde Fill Voiding Trial After Vaginal Apex Suspension
Baseline characteristics by cohort
| Measure |
Retrograde Fill Voiding Trial Method
n=87 Participants
Bladder drained w/indwelling foley catheter, then retrograde filled with 300cc sterile water. Catheter removed. \\Patient voids within 20 minutes (if unable to void after 20 minutes, she will be discharged home with a catheter secondary to voiding dysfunction). Patient subjectively quantify their force of stream via visual analog scale (VAS) scale (however this information will only be used for research purposes). If she voids \>/= 2/3 (200cc) catheter will remain out as she will have passed her voiding trial. If she voids \<200cc she will be discharged home with a catheter and instructed to follow-up in 2-5 days for an in-office retrograde voiding trial.
TOV: 1 of 2 tests to assess bladder function after vaginal apex suspension surgery with or without mid-urethral sling Foley catheter: If subject is unable to void adequately, a Foley catheter will be placed as per protocol and the subject discharged home with catheter. Subject will follow up in the office for removal of catheter.
|
Force of Stream (FAST) Voiding Trial Method
n=86 Participants
Bladder drained with foley catheter, then retrograde filled with 300cc sterile water. Catheter removed. Patient voids within 20 min (if unable to void after 20 min, she discharged home w/catheter secondary to voiding dysfunction). Patient subjectively quantify their force of stream via VAS scale. If VAS scale \>/=50 (\>/=50%) catheter will remain out, patient is discharged home w/o measuring a PVR If VAS scale is from 0-49 (=0-49%) PVR checked via bladder scan. If PVR is \<500cc, patient discharged w/o catheter; if PVR is \>/=500cc, patient discharged w/catheter. If discharged with an indwelling foley catheter, she will have an in-office retrograde voiding trial in 2-5 days.
TOV: 1 of 2 tests to assess bladder function after vaginal apex suspension surgery with or without mid-urethral sling Foley catheter: If subject unable to void adequately, Foley catheter placed as per protocol and subject discharged home with catheter. Subject follow up in the office for removal of catheter.
|
Total
n=173 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
63.1 years
STANDARD_DEVIATION 11.4 • n=5 Participants
|
62.7 years
STANDARD_DEVIATION 10.5 • n=7 Participants
|
62.9 years
STANDARD_DEVIATION 11.1 • n=5 Participants
|
|
Sex/Gender, Customized
female
|
87 Participants
n=5 Participants
|
86 Participants
n=7 Participants
|
173 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
10 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
77 Participants
n=5 Participants
|
78 Participants
n=7 Participants
|
155 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 6 weeksOutcome measures
| Measure |
Retrograde Fill Voiding Trial Method
n=64 Participants
Bladder drained w/indwelling foley catheter, then retrograde filled with 300cc sterile water. Catheter removed. \\Patient voids within 20 minutes (if unable to void after 20 minutes, she will be discharged home with a catheter secondary to voiding dysfunction). Patient subjectively quantify their force of stream via visual analog scale (VAS) scale (however this information will only be used for research purposes). If she voids \>/= 2/3 (200cc) catheter will remain out as she will have passed her voiding trial. If she voids \<200cc she will be discharged home with a catheter and instructed to follow-up in 2-5 days for an in-office retrograde voiding trial.
TOV: 1 of 2 tests to assess bladder function after vaginal apex suspension surgery with or without mid-urethral sling Foley catheter: If subject is unable to void adequately, a Foley catheter will be placed as per protocol and the subject discharged home with catheter. Subject will follow up in the office for removal of catheter.
|
Force of Stream (FAST) Voiding Trial Method
n=71 Participants
Bladder drained with foley catheter, then retrograde filled with 300cc sterile water. Catheter removed. Patient voids within 20 min (if unable to void after 20 min, she discharged home w/catheter secondary to voiding dysfunction). Patient subjectively quantify their force of stream via VAS scale. If VAS scale \>/=50 (\>/=50%) catheter will remain out, patient is discharged home w/o measuring a PVR If VAS scale is from 0-49 (=0-49%) PVR checked via bladder scan. If PVR is \<500cc, patient discharged w/o catheter; if PVR is \>/=500cc, patient discharged w/catheter. If discharged with an indwelling foley catheter, she will have an in-office retrograde voiding trial in 2-5 days.
TOV: 1 of 2 tests to assess bladder function after vaginal apex suspension surgery with or without mid-urethral sling Foley catheter: If subject unable to void adequately, Foley catheter placed as per protocol and subject discharged home with catheter. Subject follow up in the office for removal of catheter.
|
|---|---|---|
|
Number of Subjects Catheterized Within the Six-week Post-operative Period Following Surgical Repair of Prolapse, Among Those Discharged Without a Urinary Catheter.
|
2 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: 6 weeksOutcome measures
| Measure |
Retrograde Fill Voiding Trial Method
n=87 Participants
Bladder drained w/indwelling foley catheter, then retrograde filled with 300cc sterile water. Catheter removed. \\Patient voids within 20 minutes (if unable to void after 20 minutes, she will be discharged home with a catheter secondary to voiding dysfunction). Patient subjectively quantify their force of stream via visual analog scale (VAS) scale (however this information will only be used for research purposes). If she voids \>/= 2/3 (200cc) catheter will remain out as she will have passed her voiding trial. If she voids \<200cc she will be discharged home with a catheter and instructed to follow-up in 2-5 days for an in-office retrograde voiding trial.
TOV: 1 of 2 tests to assess bladder function after vaginal apex suspension surgery with or without mid-urethral sling Foley catheter: If subject is unable to void adequately, a Foley catheter will be placed as per protocol and the subject discharged home with catheter. Subject will follow up in the office for removal of catheter.
|
Force of Stream (FAST) Voiding Trial Method
n=86 Participants
Bladder drained with foley catheter, then retrograde filled with 300cc sterile water. Catheter removed. Patient voids within 20 min (if unable to void after 20 min, she discharged home w/catheter secondary to voiding dysfunction). Patient subjectively quantify their force of stream via VAS scale. If VAS scale \>/=50 (\>/=50%) catheter will remain out, patient is discharged home w/o measuring a PVR If VAS scale is from 0-49 (=0-49%) PVR checked via bladder scan. If PVR is \<500cc, patient discharged w/o catheter; if PVR is \>/=500cc, patient discharged w/catheter. If discharged with an indwelling foley catheter, she will have an in-office retrograde voiding trial in 2-5 days.
TOV: 1 of 2 tests to assess bladder function after vaginal apex suspension surgery with or without mid-urethral sling Foley catheter: If subject unable to void adequately, Foley catheter placed as per protocol and subject discharged home with catheter. Subject follow up in the office for removal of catheter.
|
|---|---|---|
|
Number of Subjects Discharged With a Catheter (This is Essentially the Proportion of Patients Who Failed the Voiding Trial)
|
23 Participants
|
15 Participants
|
SECONDARY outcome
Timeframe: 6 weeksOutcome measures
| Measure |
Retrograde Fill Voiding Trial Method
n=86 Participants
Bladder drained w/indwelling foley catheter, then retrograde filled with 300cc sterile water. Catheter removed. \\Patient voids within 20 minutes (if unable to void after 20 minutes, she will be discharged home with a catheter secondary to voiding dysfunction). Patient subjectively quantify their force of stream via visual analog scale (VAS) scale (however this information will only be used for research purposes). If she voids \>/= 2/3 (200cc) catheter will remain out as she will have passed her voiding trial. If she voids \<200cc she will be discharged home with a catheter and instructed to follow-up in 2-5 days for an in-office retrograde voiding trial.
TOV: 1 of 2 tests to assess bladder function after vaginal apex suspension surgery with or without mid-urethral sling Foley catheter: If subject is unable to void adequately, a Foley catheter will be placed as per protocol and the subject discharged home with catheter. Subject will follow up in the office for removal of catheter.
|
Force of Stream (FAST) Voiding Trial Method
n=87 Participants
Bladder drained with foley catheter, then retrograde filled with 300cc sterile water. Catheter removed. Patient voids within 20 min (if unable to void after 20 min, she discharged home w/catheter secondary to voiding dysfunction). Patient subjectively quantify their force of stream via VAS scale. If VAS scale \>/=50 (\>/=50%) catheter will remain out, patient is discharged home w/o measuring a PVR If VAS scale is from 0-49 (=0-49%) PVR checked via bladder scan. If PVR is \<500cc, patient discharged w/o catheter; if PVR is \>/=500cc, patient discharged w/catheter. If discharged with an indwelling foley catheter, she will have an in-office retrograde voiding trial in 2-5 days.
TOV: 1 of 2 tests to assess bladder function after vaginal apex suspension surgery with or without mid-urethral sling Foley catheter: If subject unable to void adequately, Foley catheter placed as per protocol and subject discharged home with catheter. Subject follow up in the office for removal of catheter.
|
|---|---|---|
|
Proportion of Patients With Unexpected Visits to the Clinic, Within the Six-week Post-operative Period.
|
8 Participants
|
6 Participants
|
Adverse Events
Retrograde Fill Voiding Trial Method
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Force of Stream (FAST) Voiding Trial Method
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