Optimization of Spontaneous Postoperative Trial of Void Among Women

Urinary Retention Postoperative Clinical Trial

— OPTION  

Official title:

Optimization of Spontaneous Trial of Void: a Prospective Cohort Study

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04010656
• Other study ID #: WIH IRB 1145237
• Status: Active, not recruiting
• Phase: N/A
• Start date: September 10, 2018
• Est. completion date: December 30, 2021

Study information

• Verified date: July 2021
• Source: Women and Infants Hospital of Rhode Island
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 183
• Est. completion date: December 30, 2021
• Est. primary completion date: May 10, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• English-speaking women, age >18yo

• Scheduled for urogynecology procedure which will need post-operative trial of void (including pelvic organ prolapse and/or stress urinary incontinence repair), with plan for same-day discharge.

Exclusion Criteria:

• Unable or unwilling to perform self-catheterizatoin either by patient or willing family member

• Pre-existing voiding dysfunction defined as documented PVR > 200 mL

• Intraoperative urinary tract injury needing indwelling catheter on discharge

• Need for overnight admission

Related Conditions & MeSH terms

• Urinary Retention
• Urinary Retention Postoperative
• Voiding Disorders

Intervention

Procedure:
• PVR-based self-catheterization
Home self-catheterization based on standard of care

Locations

Country	Name	City	State
United States	Women & Infants Hospital	Providence	Rhode Island

Sponsors (3)

Lead Sponsor	Collaborator
Women and Infants Hospital of Rhode Island	American Association of Gynecologic Laparoscopists, American Urogynecologic Society

Country where clinical trial is conducted

United States, 

References & Publications (30)

Asimakopoulos AD, De Nunzio C, Kocjancic E, Tubaro A, Rosier PF, Finazzi-Agrò E. Measurement of post-void residual urine. Neurourol Urodyn. 2016 Jan;35(1):55-7. doi: 10.1002/nau.22671. Epub 2014 Sep 22. — View Citation

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. — View Citation

Bickhaus JA, Drobnis EZ, Critchlow WA, Occhino JA, Foster RT Sr. The Feasibility of Clean Intermittent Self-Catheterization Teaching in an Outpatient Setting. Female Pelvic Med Reconstr Surg. 2015 Jul-Aug;21(4):220-4. doi: 10.1097/SPV.0000000000000155. — View Citation

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. — View Citation

Dieter AA, Amundsen CL, Visco AG, Siddiqui NY. Treatment for urinary tract infection after midurethral sling: a retrospective study comparing patients who receive short-term postoperative catheterization and patients who pass a void trial on the day of surgery. Female Pelvic Med Reconstr Surg. 2012 May-Jun;18(3):175-8. doi: 10.1097/SPV.0b013e3182544e03. — View Citation

Dörflinger A, Monga A. Voiding dysfunction. Curr Opin Obstet Gynecol. 2001 Oct;13(5):507-12. Review. — View Citation

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. — View Citation

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. — View Citation

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. Review. — View Citation

Glavind K, Mørup 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. — View Citation

Goode PS, Locher JL, Bryant RL, Roth DL, Burgio KL. Measurement of postvoid residual urine with portable transabdominal bladder ultrasound scanner and urethral catheterization. Int Urogynecol J Pelvic Floor Dysfunct. 2000;11(5):296-300. — View Citation

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. — View Citation

Hakvoort RA, Nieuwkerk PT, Burger MP, Emanuel MH, Roovers JP. Patient preferences for clean intermittent catheterisation and transurethral indwelling catheterisation for treatment of abnormal post-void residual bladder volume after vaginal prolapse surgery. BJOG. 2011 Oct;118(11):1324-8. doi: 10.1111/j.1471-0528.2011.03056.x. Epub 2011 Jul 29. — View Citation

Hakvoort RA, Thijs SD, Bouwmeester FW, Broekman AM, Ruhe IM, Vernooij MM, Burger MP, Emanuel MH, Roovers JP. Comparing clean intermittent catheterisation and transurethral indwelling catheterisation for incomplete voiding after vaginal prolapse surgery: a multicentre randomised trial. BJOG. 2011 Aug;118(9):1055-60. doi: 10.1111/j.1471-0528.2011.02935.x. Epub 2011 Apr 11. — View Citation

Homma Y, Yoshida M, Seki N, Yokoyama O, Kakizaki H, Gotoh M, Yamanishi T, Yamaguchi O, Takeda M, Nishizawa O. Symptom assessment tool for overactive bladder syndrome--overactive bladder symptom score. Urology. 2006 Aug;68(2):318-23. — View Citation

Ingber MS, Vasavada SP, Moore CK, Rackley RR, Firoozi F, Goldman HB. Force of stream after sling therapy: safety and efficacy of rapid discharge care pathway based on subjective patient report. J Urol. 2011 Mar;185(3):993-7. doi: 10.1016/j.juro.2010.10.050. Epub 2011 Jan 19. — View Citation

Kamilya G, Seal SL, Mukherji J, Bhattacharyya SK, Hazra A. A randomized controlled trial comparing short versus long-term catheterization after uncomplicated vaginal prolapse surgery. J Obstet Gynaecol Res. 2010 Feb;36(1):154-8. doi: 10.1111/j.1447-0756.2009.01096.x. — View Citation

Kessler TM, Ryu G, Burkhard FC. Clean intermittent self-catheterization: a burden for the patient? Neurourol Urodyn. 2009;28(1):18-21. doi: 10.1002/nau.20610. — View Citation

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. — View Citation

Kowalik U, Plante MK. Urinary Retention in Surgical Patients. Surg Clin North Am. 2016 Jun;96(3):453-67. doi: 10.1016/j.suc.2016.02.004. Review. — View Citation

Myers EM, Matthews CA, Crane AK, Connolly A, Wu JM, Geller EJ. Two techniques for assessing postoperative voiding function, a randomized trial. Int Urogynecol J. 2017 Oct;28(10):1567-1572. doi: 10.1007/s00192-017-3310-y. Epub 2017 Mar 11. — View Citation

Niël-Weise BS, van den Broek PJ. Urinary catheter policies for short-term bladder drainage in adults. Cochrane Database Syst Rev. 2005 Jul 20;(3):CD004203. Review. Update in: Cochrane Database Syst Rev. 2015;12:CD004203. — View Citation

Parsons BA, Narshi A, Drake MJ. Success rates for learning intermittent self-catheterisation according to age and gender. Int Urol Nephrol. 2012 Aug;44(4):1127-31. doi: 10.1007/s11255-012-0136-x. Epub 2012 Feb 18. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Rosseland LA, Stubhaug A, Breivik H. Detecting postoperative urinary retention with an ultrasound scanner. Acta Anaesthesiol Scand. 2002 Mar;46(3):279-82. — View Citation

Saint S. Clinical and economic consequences of nosocomial catheter-related bacteriuria. Am J Infect Control. 2000 Feb;28(1):68-75. — View Citation

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. — View Citation

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. Epub 2007 Dec 21. — View Citation

* Note: There are 30 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of post-operative urinary retention	Based on defined criteria	24-72 hours postoperative
Primary	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)
Secondary	Rate of post-operative and post-discharge urinary retention	Based on post-void residual volume	24-72 hours postoperative
Secondary	Rate of post-operative urinary tract infection	UTI in first 6 weeks postoperative	6 weeks postoperative
Secondary	Patient satisfaction with self-catheterization method via questionnaire	Novel questionnaire, 5 point Likert scale from "Very dissatisfied to Very satisfied"	2 weeks postoperative
Secondary	Time to first void postoperative	To assess time to spontaneous void after surgery	4 hours postoperative