Vaginal Apical Prolapse
Conditions
Keywords
voiding trial, prolapse
Brief summary
Voiding difficulties are common after prolapse and incontinence surgeries. All patients after vaginal prolapse surgery must complete a voiding trial if they are to be discharged home without a catheter. Accepted protocols for voiding trials after prolapse and incontinence surgeries do not exist. The purpose of this study is to compare two different types of postoperative voiding trials to determine which leads to less postoperative issues, such as urinary retention requiring catheterization. You are being asked to participate because you are having a vaginal apex suspension surgery.
Detailed description
It is common to have voiding difficulties after prolapse and incontinence surgeries. Difficulties in voiding are seen in up to 47% of patients after transvaginal prolapse surgery in the immediate hours postoperatively (6). Accepted protocols for voiding trials after prolapse and incontinence surgeries do not exist. Traditionally, many surgeons measure postvoid residual (PVR) urine volume to assess incomplete bladder emptying by retrograde filling the bladder with a predetermined amount of normal saline or water. The catheter is then removed and the patient is permitted to void into a collection basin. The need for postoperative catheterization is generally based on arbitrarily determined ratios of voided urine to PVR. The force of stream trial (FAST) does not prioritize amount voided, but rather the patient's subjective force of stream. Using FAST, a patient uses a visual analog scale (VAS) scale to quantify her force of stream. If she states that her Force of Stream (FOS) is \>50% of her baseline prior to surgery, independent of the amount voided, she is discharged without a catheter. If the FOS is \<50%, a PVR is measured via bladder scan. If her PVR is \<500cc the patient is discharged home. No randomized control trials (RCT) have been performed comparing the FAST method to the traditional retrograde voiding trial in subjects undergoing vaginal apex prolapse surgery despite the promising findings that FAST voiding trials are as reliable and safe as retrograde voiding trials in patients undergoing anti-incontinence surgeries. Standard in our practice is to perform a voiding trial on postoperative day 1 on all patients after vaginal apical prolapse surgery if they are to be discharged without a catheter. Investigators would like to compare the FAST voiding trial to a traditional retrograde fill voiding trial with respect to the rate of catheterization among those discharged without a catheter within the six-week postoperative period in patients undergoing a vaginal apex prolapse surgery. Investigators hypothesize the FAST voiding trial method is not inferior to traditional retrograde voiding trial. Subjects will complete questionnaires to examine postoperative bladder function, symptom distress and quality of life before and after surgery during their routine postoperative visits.
Interventions
OTHERvoiding trial
1 of 2 tests to assess bladder function after vaginal apex suspension surgery with or without mid-urethral sling
DEVICEFoley catheter
If subject is unable to void adequately, a Foley catheter will be placed as per protocol and the subject discharged home with catheter. The subject will follow up in the office for removal of catheter.
Sponsors
Northwell Health
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 95 Years
Healthy volunteers
Yes
Inclusion criteria
1\. Women undergoing vaginal apex surgery (sacrocolpopexy, sacrospinous ligament suspension, uterosacral ligament suspension, colpocleisis) with or without mid-urethral sling, with or without anterior or posterior colporrhaphy
Exclusion criteria
1. Patients who underwent a surgery that requires long term catheterization (i.e fistula repair or urethral diverticulum) 2. Patients who sustained a cystotomy during surgery as our divisional protocol is to send these patients home with a Foley catheter for 5-14 days without a voiding trial 3. Patients with baseline urinary retention and the inability to urinate without catheterization 4. Pregnant women
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of Subjects Catheterized Within the Six-week Post-operative Period Following Surgical Repair of Prolapse, Among Those Discharged Without a Urinary Catheter. | 6 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Number of Subjects Discharged With a Catheter (This is Essentially the Proportion of Patients Who Failed the Voiding Trial) | 6 weeks |
| Proportion of Patients With Unexpected Visits to the Clinic, Within the Six-week Post-operative Period. | 6 weeks |
Countries
United States
Participant flow
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| Retrograde Fill Voiding Trial Method 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. | 87 |
| Force of Stream (FAST) Voiding Trial Method 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. | 86 |
| Total | 173 |
Baseline characteristics
| Characteristic | Total | Retrograde Fill Voiding Trial Method | Force of Stream (FAST) Voiding Trial Method |
|---|---|---|---|
| Age, Continuous | 62.9 years STANDARD_DEVIATION 11.1 | 63.1 years STANDARD_DEVIATION 11.4 | 62.7 years STANDARD_DEVIATION 10.5 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 18 Participants | 10 Participants | 8 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 155 Participants | 77 Participants | 78 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Sex/Gender, Customized female | 173 Participants | 87 Participants | 86 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 87 | 0 / 86 |
| other Total, other adverse events | 0 / 87 | 0 / 86 |
| serious Total, serious adverse events | 0 / 87 | 0 / 86 |
Outcome results
Primary
Number of Subjects Catheterized Within the Six-week Post-operative Period Following Surgical Repair of Prolapse, Among Those Discharged Without a Urinary Catheter.
Time frame: 6 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Retrograde Fill Voiding Trial Method | 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 |
| Force of Stream (FAST) Voiding Trial Method | 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 |
Secondary
Number of Subjects Discharged With a Catheter (This is Essentially the Proportion of Patients Who Failed the Voiding Trial)
Time frame: 6 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Retrograde Fill Voiding Trial Method | Number of Subjects Discharged With a Catheter (This is Essentially the Proportion of Patients Who Failed the Voiding Trial) | 23 Participants |
| Force of Stream (FAST) Voiding Trial Method | Number of Subjects Discharged With a Catheter (This is Essentially the Proportion of Patients Who Failed the Voiding Trial) | 15 Participants |
Secondary
Proportion of Patients With Unexpected Visits to the Clinic, Within the Six-week Post-operative Period.
Time frame: 6 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Retrograde Fill Voiding Trial Method | Proportion of Patients With Unexpected Visits to the Clinic, Within the Six-week Post-operative Period. | 8 Participants |
| Force of Stream (FAST) Voiding Trial Method | Proportion of Patients With Unexpected Visits to the Clinic, Within the Six-week Post-operative Period. | 6 Participants |