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| Name | Class |
|---|---|
| American Urogynecologic Society | OTHER |
| American Association of Gynecologic Laparoscopists | OTHER |
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Trial of void (TOV) is a diagnostic test performed on all women who undergo prolapse repair or incontinence surgery, due to the importance of diagnosing postoperative urinary retention (POUR). Incidence of POUR may be as high as 62% in some studies. Timely and accurate diagnosis is important to avoid complications such as urinary tract infection, bladder overdistension, and permanent bladder injury. Despite the frequent use of TOV, there is no gold standard for the test, and it likely has poor specificity, leading to discharge of more patients with catheter than required. This prospective cohort study will seek to establish evidence-based optimal parameters for spontaneous trial of void, a TOV modality that has merit for further evaluation given lower theoretical risk of urinary tract infection.
Patients will learn to perform self-catheterization ('clean intermittent catheterization', or CIC) preoperatively; after surgery, the investigators will collect a range of voiding parameters used during different TOV protocols (including minimum voided volume [MVV], post-void residual via bladder scanner [PVR], subjective force of urinary stream [sFOS]). Patients will discharge home to perform CIC until two sequential post-void residuals of less than half the volume voided have been achieved. The rate of voiding dysfunction and resulting PVRs will be used to compare the diagnostic accuracy of the perioperative voiding parameters to predict need to perform CIC and post-operative urinary retention.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PVR-based home self-catheterization | Experimental | Patients will learn to self-catheterize preoperatively prior to urogynecology surgery requiring trial of void. First post-operative void will be used to collect basic information about voiding function. All participants will leave the hospital and self-catheterize until they achieve two sequential voids with post-void residual (PVR) less than half the volume voided. The cases of urinary retention captured with abnormal PVR will be used to compare the diagnostic accuracy of several commonly-used, pre-defined parameters for trial of void. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PVR-based self-catheterization | Procedure | Home self-catheterization based on standard of care |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of post-operative urinary retention | Based on defined criteria | 24-72 hours postoperative |
| Diagnostic accuracy of trial of void parameters | Comparison of sensitivity, specificity, positive/negative predictive value of different trial of void parameters from first postoperative void, based on those used in the literature. | First void postoperative (within 4 hours postop) |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of post-operative and post-discharge urinary retention | Based on post-void residual volume | 24-72 hours postoperative |
| Rate of post-operative urinary tract infection | UTI in first 6 weeks postoperative |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Anne C Cooper, MD, MA | Dartmouth-Hitchcock Medical Center, Lebanon NH | Principal Investigator |
| Julia Shinnick, MD | Women & Infants Hospital, Providence RI | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Women & Infants Hospital | Providence | Rhode Island | 02903 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 11547032 | Background | Dorflinger A, Monga A. Voiding dysfunction. Curr Opin Obstet Gynecol. 2001 Oct;13(5):507-12. doi: 10.1097/00001703-200110000-00010. | |
| 12066111 | Background | Partoll LM. Efficacy of tension-free vaginal tape with other pelvic reconstructive surgery. Am J Obstet Gynecol. 2002 Jun;186(6):1292-5; discussion 1295-8. doi: 10.1067/mob.2002.123736. |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | May 1, 2025 | |
| Reset | May 19, 2025 | |
| Release | May 30, 2025 | |
| Reset | Jun 16, 2025 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| May 1, 2025 | May 19, 2025 | |||
| May 30, 2025 |
Subjects will be taught to perform self-catheterization prior to prolapse repair or incontinence surgery; voiding data will be collected on the participant's first void after surgery. Participants will be discharged home to perform self-catheterization until post-void residual is less than half the volume voided on 2 sequential voids to assess actual voiding function, and this data will be used to calculate the diagnostic accuracy of pre-determined combinations of the TOV parameters.
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| 6 weeks postoperative |
| Patient satisfaction with self-catheterization method via questionnaire | Novel questionnaire, 5 point Likert scale from "Very dissatisfied to Very satisfied" | 2 weeks postoperative |
| Time to first void postoperative | To assess time to spontaneous void after surgery | 4 hours postoperative |
| 18310363 | Background | Barber MD, Kleeman S, Karram MM, Paraiso MF, Walters MD, Vasavada S, Ellerkmann M. Transobturator tape compared with tension-free vaginal tape for the treatment of stress urinary incontinence: a randomized controlled trial. Obstet Gynecol. 2008 Mar;111(3):611-21. doi: 10.1097/AOG.0b013e318162f22e. |
| 25210477 | Background | Geller EJ. Prevention and management of postoperative urinary retention after urogynecologic surgery. Int J Womens Health. 2014 Aug 28;6:829-38. doi: 10.2147/IJWH.S55383. eCollection 2014. |
| 21860294 | Background | Geller EJ, Hankins KJ, Parnell BA, Robinson BL, Dunivan GC. Diagnostic accuracy of retrograde and spontaneous voiding trials for postoperative voiding dysfunction: a randomized controlled trial. Obstet Gynecol. 2011 Sep;118(3):637-642. doi: 10.1097/AOG.0b013e318229e8dd. |
| 14994912 | Background | de Souza GM, Costa WS, Bruschini H, Sampaio FJ. Morphological analysis of the acute effects of overdistension on the extracellular matrix of the rat urinary bladder wall. Ann Anat. 2004 Feb;186(1):55-9. doi: 10.1016/S0940-9602(04)80122-5. |
| 11939918 | Background | Rosseland LA, Stubhaug A, Breivik H. Detecting postoperative urinary retention with an ultrasound scanner. Acta Anaesthesiol Scand. 2002 Mar;46(3):279-82. doi: 10.1034/j.1399-6576.2002.t01-1-460309.x. |
| 25251215 | Background | Asimakopoulos AD, De Nunzio C, Kocjancic E, Tubaro A, Rosier PF, Finazzi-Agro E. Measurement of post-void residual urine. Neurourol Urodyn. 2016 Jan;35(1):55-7. doi: 10.1002/nau.22671. Epub 2014 Sep 22. |
| 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. |
| 19130599 | Background | Hakvoort RA, Dijkgraaf MG, Burger MP, Emanuel MH, Roovers JP. Predicting short-term urinary retention after vaginal prolapse surgery. Neurourol Urodyn. 2009;28(3):225-8. doi: 10.1002/nau.20636. |
| 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. |
| 12114887 | Background | Kleeman S, Goldwasser S, Vassallo B, Karram M. Predicting postoperative voiding efficiency after operation for incontinence and prolapse. Am J Obstet Gynecol. 2002 Jul;187(1):49-52. doi: 10.1067/mob.2002.124841. |
| 18060956 | Background | Foster RT Sr, Borawski KM, South MM, Weidner AC, Webster GD, Amundsen CL. A randomized, controlled trial evaluating 2 techniques of postoperative bladder testing after transvaginal surgery. Am J Obstet Gynecol. 2007 Dec;197(6):627.e1-4. doi: 10.1016/j.ajog.2007.08.017. |
| 10679141 | Background | Saint S. Clinical and economic consequences of nosocomial catheter-related bacteriuria. Am J Infect Control. 2000 Feb;28(1):68-75. doi: 10.1016/s0196-6553(00)90015-4. |
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| 20727543 | Background | Pulvino JQ, Duecy EE, Buchsbaum GM, Flynn MK. Comparison of 2 techniques to predict voiding efficiency after inpatient urogynecologic surgery. J Urol. 2010 Oct;184(4):1408-12. doi: 10.1016/j.juro.2010.05.096. Epub 2010 Aug 19. |
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| Jun 16, 2025 |