Pelvic Organ Prolapse, Surgery, Urinary Incontinence,Stress
Conditions
Brief summary
This study is a randomized controlled trial designed to assess the rate of failure of voiding trials in the early and late post-operative period within patients who underwent outpatient pelvic floor surgery that failed initial same day voiding trials.
Detailed description
This study would be powered to detect differences in UTIs and Foley catheter re-insertion rates. Assuming a 10% drop-out rate, 100 total subjects should be enrolled in the study. All patients that meet the appropriate inclusion criteria and are scheduled for outpatient pelvic floor surgery will be considered for the study. Patients will be counseled about the study either in the office during a surgical planning office visit, over a pre-operative telephone call, or in the pre-operative area just prior to surgery. Consents will be signed in the pre-operative area. After surgery, the patient will be given a standardized voiding trial as per the usual protocol. If the patient is un-successful in emptying her bladder she will be discharged home with an indwelling Foley catheter with antibiotics. On post-operative day (POD) #1 the patient will be re-assessed for meeting eligibility requirements and will be called and randomized to either the early voiding trial group (EVT) or the late voiding trial group (LVT). Subjects in EVT will be scheduled for a repeat VT on POD#2, POD#3, or POD#4, whereas those in LVT will be scheduled for a repeat VT on or after POD#7. Subjects that are unsuccessful in the repeat VT will have a Foley catheter re-inserted and will return for another VT in 5-7 days. Subjects who fail the third VT from either group will have the Foley catheter replaced and will return for another office VT after waiting an additional 5-7 days or will be started on clean intermittent self-catheterization. Subjects will be monitored for a 6 week period for voiding and urinary symptoms. Urine will be tested via in-office urinalysis at each office visit, including pre-operatively, and will be sent for a urine culture per usual practice based upon abnormal urinalysis results. Urine cultures that grow out a single organism \>10,000 CFU will be treated with appropriate antibiotics. In addition, patients will complete quality of life questionnaires at the time of catheter removal, the standard 2 week post-op visit and at 6weeks post-operatively.
Interventions
DEVICEFoley 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.
DEVICEFoley 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
Sponsors
Wake Forest University Health Sciences
The Cleveland Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Female patients * Over 18 years old * Speak English and are capable of giving informed consent and are able to complete the English patient questionnaire * Are willing to return to the office for all necessary visits associated with the study * Had outpatient gynecology pelvic floor surgery for prolapse or stress urinary incontinence * Failed the voiding trial in the recovery room * Discharged to home on POD#0
Exclusion criteria
* Pre-operative urinary retention as defined as PVR \> 200ml * Prior incontinence surgery * Passed the voiding trial in the recovery room * Require prolonged catheterization due to urethral/bladder abnormality (ie vesicovaginal fistula, urethral diverticulum) or intra-op urethral or bladder injury or for intensive post-operative monitoring * Patients who take any post-operative antibiotics, other than prophylaxis during catheterization, for reasons other than a UTI as diagnosed and prescribed as part of the study * Patients who take any supplements to prevent UTIs, including but not limited to D-Mannose, Hiprex, or Ellura * Receive any post-operative vaginal estrogen during the study period * Have any neurological conditions that may affect bladder function (ie. Multiple sclerosis, spinal cord injuries, etc.) * Patients with pre-operative narcotic medication use due to chronic pain * Patients who take any over-active bladder medication within one week of their surgery
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Failed Office Voiding Trials | within 8 days of surgery | Determine the rates of failed voiding trials in each of the two groups |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Urinary Tract Infections | within 6 weeks of surgery | Determine the rates of urinary tract infections in each of the two groups |
| Rate of Bother From Urinary Catheter | within 6 weeks of surgery | Determine the rates of patient satisfaction in each of the two groups using a Likert scale (1= very bothersome; 5= Not bothersome at all) |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 32 |
| 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 | 32 |
| Total | 64 |
Baseline characteristics
| Characteristic | Late Voiding Trial | Total | Early Voiding Trial |
|---|---|---|---|
| Age, Continuous | 65.31 years STANDARD_DEVIATION 11.45 | 64.69 years STANDARD_DEVIATION 11.67 | 64.06 years STANDARD_DEVIATION 12.04 |
| Anesthesia General | 32 Participants | 63 Participants | 31 Participants |
| Anesthesia Spinal | 0 Participants | 1 Participants | 1 Participants |
| Anterior Colporrhaphy | 27 Participants | 51 Participants | 24 Participants |
| Apical Suspension | 27 Participants | 52 Participants | 25 Participants |
| BMI | 26.34 kg/m^2 STANDARD_DEVIATION 5.23 | 27.29 kg/m^2 STANDARD_DEVIATION 6.07 | 28.24 kg/m^2 STANDARD_DEVIATION 6.77 |
| Concurrent vaginal hysterectomy | 11 Participants | 32 Participants | 21 Participants |
| Intra-operative Urine Dye Fluorescein | 3 Participants | 10 Participants | 7 Participants |
| Intra-operative Urine Dye Indigo Carmine | 5 Participants | 10 Participants | 5 Participants |
| Intra-operative Urine Dye None | 23 Participants | 41 Participants | 18 Participants |
| Intra-operative Urine Dye Phenazopyridine | 1 Participants | 3 Participants | 2 Participants |
| Intra-operative use of Furosemide | 5 Participants | 9 Participants | 4 Participants |
| Midurethral Sling | 14 Participants | 32 Participants | 18 Participants |
| POP-Q stage POP- Q Stage II | 10 Participants | 25 Participants | 15 Participants |
| POP-Q stage POP- Q Stage III | 21 Participants | 36 Participants | 15 Participants |
| POP-Q stage POP-Q Stage IV | 1 Participants | 3 Participants | 2 Participants |
| Posterior Colporrhaphy | 32 Participants | 62 Participants | 30 Participants |
| Postmenopausal | 27 Participants | 55 Participants | 28 Participants |
| pre-operative post void residual | 38.94 ml STANDARD_DEVIATION 39.62 | 38.89 ml STANDARD_DEVIATION 34.9 | 38.84 ml STANDARD_DEVIATION 30.11 |
| prior hysterectomy | 9 Participants | 17 Participants | 8 Participants |
| Race/Ethnicity, Customized African American | 1 participants | 7 participants | 6 participants |
| Race/Ethnicity, Customized Caucasian | 26 participants | 49 participants | 23 participants |
| Race/Ethnicity, Customized Hispanic | 5 participants | 8 participants | 3 participants |
| Region of Enrollment United States | 32 participants | 64 participants | 32 participants |
| Sex: Female, Male Female | 32 Participants | 64 Participants | 32 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
| Smoking status Current | 0 Participants | 0 Participants | 0 Participants |
| Smoking status Former | 5 Participants | 9 Participants | 4 Participants |
| Smoking status Never | 27 Participants | 55 Participants | 28 Participants |
| Total Morphine Dose Equivalents | 18.67 morphine dose equivalents STANDARD_DEVIATION 8.72 | 20.06 morphine dose equivalents STANDARD_DEVIATION 10.41 | 21.45 morphine dose equivalents STANDARD_DEVIATION 11.85 |
| Type of Apical Suspension Sacrospinous Fixation | 14 Participants | 24 Participants | 10 Participants |
| Type of Apical Suspension Uterosacral Suspension | 13 Participants | 28 Participants | 15 Participants |
| Urodynamic diagnosed incontinence DO | 3 Participants | 4 Participants | 1 Participants |
| Urodynamic diagnosed incontinence ISD | 3 Participants | 5 Participants | 2 Participants |
| Urodynamic diagnosed incontinence None | 14 Participants | 28 Participants | 14 Participants |
| Urodynamic diagnosed incontinence SUI | 9 Participants | 20 Participants | 11 Participants |
| Vaginal Pack Used | 13 Participants | 28 Participants | 15 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 30 | 0 / 30 |
| other Total, other adverse events | 0 / 30 | 0 / 30 |
| serious Total, serious adverse events | 0 / 30 | 0 / 30 |
Outcome results
Primary
Failed Office Voiding Trials
Determine the rates of failed voiding trials in each of the two groups
Time frame: within 8 days of surgery
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Early Voiding Trial | Failed Office Voiding Trials | 7 Participants |
| Late Voiding Trial | Failed Office Voiding Trials | 1 Participants |
Secondary
Rate of Bother From Urinary Catheter
Determine the rates of patient satisfaction in each of the two groups using a Likert scale (1= very bothersome; 5= Not bothersome at all)
Time frame: within 6 weeks of surgery
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Early Voiding Trial | Rate of Bother From Urinary Catheter | 3 score on a scale |
| Late Voiding Trial | Rate of Bother From Urinary Catheter | 2 score on a scale |
Secondary
Urinary Tract Infections
Determine the rates of urinary tract infections in each of the two groups
Time frame: within 6 weeks of surgery
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Early Voiding Trial | Urinary Tract Infections | 7 Participants |
| Late Voiding Trial | Urinary Tract Infections | 2 Participants |