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| Name | Class |
|---|---|
| Wake Forest University Health Sciences | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Early Voiding Trial | Experimental | 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 |
|
| Late Voiding Trial | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Foley catheter - Early Voiding Trial | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Failed Office Voiding Trials | Determine the rates of failed voiding trials in each of the two groups | within 8 days of surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Urinary Tract Infections | Determine the rates of urinary tract infections in each of the two groups | within 6 weeks of surgery |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jeffrey Schachar, MD | The Cleveland Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cleveland Clinic Florida | Weston | Florida | 33331 | United States | ||
| Wake Forest Baptist Health |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 9441144 | Background | Alonzo-Sosa JE, Flores-Contreras JT, Paredes-Canul M. [Method for transurethral catheterization for 1-3 days for pelvic floor relaxation in the postoperative period]. Ginecol Obstet Mex. 1997 Nov;65:455-7. Spanish. | |
| 27004205 | Background | Chong C, Kim HS, Suh DH, Jee BC. Risk factors for urinary retention after vaginal hysterectomy for pelvic organ prolapse. Obstet Gynecol Sci. 2016 Mar;59(2):137-43. doi: 10.5468/ogs.2016.59.2.137. Epub 2016 Mar 16. |
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There no plan to make individual participant data available to other researchers
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Failed Office Voiding Trials | Determine the rates of failed voiding trials in each of the two groups | Posted | Count of Participants | Participants | within 8 days of surgery |
|
6 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Catherine Matthews | Wake Forest Baptist Health | 336-716-4131 | camatthe@wakehealth.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_ICF | Yes | No | Yes | Study Protocol and Informed Consent Form | Dec 1, 2018 | Jan 27, 2020 | Prot_ICF_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Dec 15, 2018 | Jul 30, 2024 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D056887 | Pelvic Organ Prolapse |
| D014550 | Urinary Incontinence, Stress |
| ID | Term |
|---|---|
| D011391 | Prolapse |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D014549 | Urinary Incontinence |
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|
| Foley catheter - Late Voiding Trial | Device | 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 |
|
| within 6 weeks of surgery |
| Winston-Salem |
| North Carolina |
| 27157 |
| United States |
| 23983149 | Background | Ferrante KL, Kim HY, Brubaker L, Wai CY, Norton PA, Kraus SR, Shepherd J, Sirls LT, Nager CW; Urinary Incontinence Treatment Network. Repeat post-op voiding trials: an inconvenient correlate with success. Neurourol Urodyn. 2014 Nov;33(8):1225-8. doi: 10.1002/nau.22489. Epub 2013 Aug 27. |
| 17712655 | Background | Glavind K, Morup L, Madsen H, Glavind J. A prospective, randomised, controlled trial comparing 3 hour and 24 hour postoperative removal of bladder catheter and vaginal pack following vaginal prolapse surgery. Acta Obstet Gynecol Scand. 2007;86(9):1122-5. doi: 10.1080/00016340701505317. |
| 15270931 | Background | Hakvoort RA, Elberink R, Vollebregt A, Ploeg T, Emanuel MH. How long should urinary bladder catheterisation be continued after vaginal prolapse surgery? A randomised controlled trial comparing short term versus long term catheterisation after vaginal prolapse surgery. BJOG. 2004 Aug;111(8):828-30. doi: 10.1111/j.1471-0528.2004.00181.x. |
| 26829348 | Background | Kandadai P, Duenas-Garcia OF, Pilzeck AL, Saini J, Flynn MK, Leung K, Patterson D. A Randomized Controlled Trial of Patient-Controlled Valve Catheter and Indwelling Foley Catheter for Short-term Bladder Drainage. Female Pelvic Med Reconstr Surg. 2016 Mar-Apr;22(2):88-92. doi: 10.1097/SPV.0000000000000249. |
| 18060968 | Background | Kenton K, Pham T, Mueller E, Brubaker L. Patient preparedness: an important predictor of surgical outcome. Am J Obstet Gynecol. 2007 Dec;197(6):654.e1-6. doi: 10.1016/j.ajog.2007.08.059. |
| 25075308 | Background | Nicolle LE. Catheter associated urinary tract infections. Antimicrob Resist Infect Control. 2014 Jul 25;3:23. doi: 10.1186/2047-2994-3-23. eCollection 2014. |
| 27319367 | Background | Ripperda CM, Kowalski JT, Chaudhry ZQ, Mahal AS, Lanzer J, Noor N, Good MM, Hynan LS, Jeppson PC, Rahn DD. Predictors of early postoperative voiding dysfunction and other complications following a midurethral sling. Am J Obstet Gynecol. 2016 Nov;215(5):656.e1-656.e6. doi: 10.1016/j.ajog.2016.06.010. Epub 2016 Jun 16. |
| 8798095 | Background | Schiotz HA. Comparison of 1 and 3 days' transurethral Foley catheterization after retropubic incontinence surgery. Int Urogynecol J Pelvic Floor Dysfunct. 1996;7(2):98-101. doi: 10.1007/BF01902381. |
| 16612711 | Background | Schiotz HA, Tanbo TG. Postoperative voiding, bacteriuria and urinary tract infection with Foley catheterization after gynecological surgery. Acta Obstet Gynecol Scand. 2006;85(4):476-81. doi: 10.1080/00016340500409877. |
| 20497880 | Background | Tan GW, Chan SP, Ho CK. Is transurethral catheterisation the ideal method of bladder drainage? A survey of patient satisfaction with indwelling transurethral urinary catheters. Asian J Surg. 2010 Jan;33(1):31-6. doi: 10.1016/S1015-9584(10)60006-1. |
| 25434837 | Background | Tunitsky-Bitton E, Murphy A, Barber MD, Goldman HB, Vasavada S, Jelovsek JE. Assessment of voiding after sling: a randomized trial of 2 methods of postoperative catheter management after midurethral sling surgery for stress urinary incontinence in women. Am J Obstet Gynecol. 2015 May;212(5):597.e1-9. doi: 10.1016/j.ajog.2014.11.033. Epub 2014 Nov 27. |
| 18082219 | Background | Wheeler TL 2nd, Richter HE, Greer WJ, Bowling CB, Redden DT, Varner RE. Predictors of success with postoperative voiding trials after a mid urethral sling procedure. J Urol. 2008 Feb;179(2):600-4. doi: 10.1016/j.juro.2007.09.080. Epub 2007 Dec 21. |
| BG001 | 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 |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | participants |
|
| Region of Enrollment | Number | participants |
|
| BMI | Mean | Standard Deviation | kg/m^2 |
|
| Smoking status | Count of Participants | Participants |
|
| Postmenopausal | Count of Participants | Participants |
|
| prior hysterectomy | Count of Participants | Participants |
|
| POP-Q stage | Subjects are staged clinically using the standard Pelvic Organ Prolapse Quantification system. Increased stage correlates with worsening pelvic organ prolapse. | Count of Participants | Participants |
|
| pre-operative post void residual | Mean | Standard Deviation | ml |
|
| Urodynamic diagnosed incontinence | Not all subjects underwent urodynamic testing. | Count of Participants | Participants |
|
| Concurrent vaginal hysterectomy | Count of Participants | Participants |
|
| Apical Suspension | Count of Participants | Participants |
|
| Type of Apical Suspension | Not all subjects underwent an apical suspension | Count of Participants | Participants |
|
| Anterior Colporrhaphy | Count of Participants | Participants |
|
| Posterior Colporrhaphy | Count of Participants | Participants |
|
| Midurethral Sling | Count of Participants | Participants |
|
| Vaginal Pack Used | Count of Participants | Participants |
|
| Intra-operative Urine Dye | Count of Participants | Participants |
|
| Intra-operative use of Furosemide | Count of Participants | Participants |
|
| Anesthesia | Count of Participants | Participants |
|
| Total Morphine Dose Equivalents | Mean | Standard Deviation | morphine dose equivalents |
|
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 |
|
|
| Secondary | Urinary Tract Infections | Determine the rates of urinary tract infections in each of the two groups | Posted | Count of Participants | Participants | within 6 weeks of surgery |
|
|
|
| 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) | Posted | Median | Inter-Quartile Range | score on a scale | within 6 weeks of surgery |
|
|
|
| 0 |
| 30 |
| 0 |
| 30 |
| 0 |
| 30 |
| EG001 | 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 | 0 | 30 | 0 | 30 | 0 | 30 |
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| D014555 | Urination Disorders |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D059411 | Lower Urinary Tract Symptoms |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| Never |
|
| ISD |
|
| DO |
|
| Indigo Carmine |
|
| Phenazopyridine |
|