Heparin Intraoperative Instillation for Lower Urinary Tract Symptoms After Benign Hysterectomy

Summary

This study will explore the application of placing heparin into the bladder via a catheter to decrease postoperative lower urinary tract symptoms (LUTS) and urinary tract infection (UTI) symptoms such as urinary frequency, urinary urgency, pain with urination, or difficulty voiding following hysterectomy (surgically removing the uterus). The investigators hypothesize that heparin bladder instillations will reduce LUTS, UTI symptoms, and improve patient satisfaction following hysterectomy.

Timeline

Start

2018-08-20

Primary completion

2019-12-31

Completion

2020-03-01

Publications

• Results Ablove T, Patankar M, Seo S. Prevention of recurrent urinary tract infections by intravesical administration of heparin: a pilot study. Ther Adv Urol. 2013 Dec;5(6):303-9. doi: 10.1177/1756287213504804.
• Results Albo ME, Richter HE, Brubaker L, Norton P, Kraus SR, Zimmern PE, Chai TC, Zyczynski H, Diokno AC, Tennstedt S, Nager C, Lloyd LK, FitzGerald M, Lemack GE, Johnson HW, Leng W, Mallett V, Stoddard AM, Menefee S, Varner RE, Kenton K, Moalli P, Sirls L, Dandreo KJ, Kusek JW, Nyberg LM, Steers W; Urinary Incontinence Treatment Network. Burch colposuspension versus fascial sling to reduce urinary stress incontinence. N Engl J Med. 2007 May 24;356(21):2143-55. doi: 10.1056/NEJMoa070416. Epub 2007 May 21.
• Results Anand M, Wang C, French J, Isaacson-Schmid M, Wall LL, Mysorekar IU. Estrogen affects the glycosaminoglycan layer of the murine bladder. Female Pelvic Med Reconstr Surg. 2012 May-Jun;18(3):148-52. doi: 10.1097/SPV.0b013e31824b76bd.
• Results Ciani O, Arendsen E, Romancik M, Lunik R, Costantini E, Di Biase M, Morgia G, Fragala E, Roman T, Bernat M, Guazzoni G, Tarricone R, Lazzeri M. Intravesical administration of combined hyaluronic acid (HA) and chondroitin sulfate (CS) for the treatment of female recurrent urinary tract infections: a European multicentre nested case-control study. BMJ Open. 2016 Mar 31;6(3):e009669. doi: 10.1136/bmjopen-2015-009669.
• Results Clayson D, Wild D, Doll H, Keating K, Gondek K. Validation of a patient-administered questionnaire to measure the severity and bothersomeness of lower urinary tract symptoms in uncomplicated urinary tract infection (UTI): the UTI Symptom Assessment questionnaire. BJU Int. 2005 Aug;96(3):350-9. doi: 10.1111/j.1464-410X.2005.05630.x.
• Results Cohen SL, Ajao MO, Clark NV, Vitonis AF, Einarsson JI. Outpatient Hysterectomy Volume in the United States. Obstet Gynecol. 2017 Jul;130(1):130-137. doi: 10.1097/AOG.0000000000002103.
• Results Damiano R, Quarto G, Bava I, Ucciero G, De Domenico R, Palumbo MI, Autorino R. Prevention of recurrent urinary tract infections by intravesical administration of hyaluronic acid and chondroitin sulphate: a placebo-controlled randomised trial. Eur Urol. 2011 Apr;59(4):645-51. doi: 10.1016/j.eururo.2010.12.039. Epub 2011 Jan 18.
• Results Desai VB, Xu X. An update on inpatient hysterectomy routes in the United States. Am J Obstet Gynecol. 2015 Nov;213(5):742-3. doi: 10.1016/j.ajog.2015.07.038. Epub 2015 Jul 28. No abstract available.
• Results Dieter AA, Amundsen CL, Edenfield AL, Kawasaki A, Levin PJ, Visco AG, Siddiqui NY. Oral antibiotics to prevent postoperative urinary tract infection: a randomized controlled trial. Obstet Gynecol. 2014 Jan;123(1):96-103. doi: 10.1097/AOG.0000000000000024.
• Results Elkadry EA, Kenton KS, FitzGerald MP, Shott S, Brubaker L. Patient-selected goals: a new perspective on surgical outcome. Am J Obstet Gynecol. 2003 Dec;189(6):1551-7; discussion 1557-8. doi: 10.1016/s0002-9378(03)00932-3.
• Results Foxman B. Epidemiology of urinary tract infections: incidence, morbidity, and economic costs. Dis Mon. 2003 Feb;49(2):53-70. doi: 10.1067/mda.2003.7.
• Results Gagyor I, Bleidorn J, Kochen MM, Schmiemann G, Wegscheider K, Hummers-Pradier E. Ibuprofen versus fosfomycin for uncomplicated urinary tract infection in women: randomised controlled trial. BMJ. 2015 Dec 23;351:h6544. doi: 10.1136/bmj.h6544.
• Results Generali JA, Cada DJ. Intravesical heparin: interstitial cystitis (painful bladder syndrome). Hosp Pharm. 2013 Nov;48(10):822-4. doi: 10.1310/hpj4810-822.
• Results Giesen LG, Cousins G, Dimitrov BD, van de Laar FA, Fahey T. Predicting acute uncomplicated urinary tract infection in women: a systematic review of the diagnostic accuracy of symptoms and signs. BMC Fam Pract. 2010 Oct 24;11:78. doi: 10.1186/1471-2296-11-78.
• Results Givens CD, Wenzel RP. Catheter-associated urinary tract infections in surgical patients: a controlled study on the excess morbidity and costs. J Urol. 1980 Nov;124(5):646-8. doi: 10.1016/s0022-5347(17)55596-2.
• Results Jackson D, Higgins E, Bracken J, Yandell PM, Shull B, Foster RT Sr. Antibiotic prophylaxis for urinary tract infection after midurethral sling: a randomized controlled trial. Female Pelvic Med Reconstr Surg. 2013 May-Jun;19(3):137-41. doi: 10.1097/SPV.0b013e318285ba53.
• Results Karp NE, Kobernik EK, Kamdar NS, Fore AM, Morgan DM. Length of Catheter Use After Hysterectomy as a Risk Factor for Urinary Tract Infection. Female Pelvic Med Reconstr Surg. 2018 Nov/Dec;24(6):430-434. doi: 10.1097/SPV.0000000000000486.
• Results Lake AG, McPencow AM, Dick-Biascoechea MA, Martin DK, Erekson EA. Surgical site infection after hysterectomy. Am J Obstet Gynecol. 2013 Nov;209(5):490.e1-9. doi: 10.1016/j.ajog.2013.06.018. Epub 2013 Jun 13.
• Results Lakeman MM, van der Vaart CH, Roovers JP; HysVA study group. Hysterectomy and lower urinary tract symptoms: a nonrandomized comparison of vaginal and abdominal hysterectomy. Gynecol Obstet Invest. 2010;70(2):100-6. doi: 10.1159/000297507. Epub 2010 Mar 19.
• Results Ley K, Laudanna C, Cybulsky MI, Nourshargh S. Getting to the site of inflammation: the leukocyte adhesion cascade updated. Nat Rev Immunol. 2007 Sep;7(9):678-89. doi: 10.1038/nri2156.
• Results Lusardi G, Lipp A, Shaw C. Antibiotic prophylaxis for short-term catheter bladder drainage in adults. Cochrane Database Syst Rev. 2013 Jul 3;2013(7):CD005428. doi: 10.1002/14651858.CD005428.pub2.
• Results Nomiya A, Naruse T, Niimi A, Nishimatsu H, Kume H, Igawa Y, Homma Y. On- and post-treatment symptom relief by repeated instillations of heparin and alkalized lidocaine in interstitial cystitis. Int J Urol. 2013 Nov;20(11):1118-22. doi: 10.1111/iju.12120. Epub 2013 Feb 22.
• Results Palsson M, Stjerndahl JH, Granasen G, Lofgren M, Sundfeldt K. Patient-reported lower urinary tract symptoms after hysterectomy or hysteroscopy: a study from the Swedish Quality Register for Gynecological Surgery. Int Urogynecol J. 2017 Sep;28(9):1341-1349. doi: 10.1007/s00192-017-3268-9. Epub 2017 Jan 23.
• Results Parsons CL, Zupkas P, Proctor J, Koziol J, Franklin A, Giesing D, Davis E, Lakin CM, Kahn BS, Garner WJ. Alkalinized lidocaine and heparin provide immediate relief of pain and urgency in patients with interstitial cystitis. J Sex Med. 2012 Jan;9(1):207-12. doi: 10.1111/j.1743-6109.2011.02542.x. Epub 2011 Nov 14.
• Results Pham T, Kenton K, Mueller E, Brubaker L. New pelvic symptoms are common after reconstructive pelvic surgery. Am J Obstet Gynecol. 2009 Jan;200(1):88.e1-5. doi: 10.1016/j.ajog.2008.08.010. Epub 2008 Oct 9.
• Results Qin C, de Oliveira G, Hackett N, Kim JY. Surgical duration and risk of Urinary Tract Infection: An analysis of 1,452,369 patients using the National Surgical Quality Improvement Program (NSQIP). Int J Surg. 2015 Aug;20:107-12. doi: 10.1016/j.ijsu.2015.05.051. Epub 2015 Jun 6.
• Results Shepherd AK, Pottinger PS. Management of urinary tract infections in the era of increasing antimicrobial resistance. Med Clin North Am. 2013 Jul;97(4):737-57, xii. doi: 10.1016/j.mcna.2013.03.006. Epub 2013 Apr 29.
• Results Thakar R, Ayers S, Clarkson P, Stanton S, Manyonda I. Outcomes after total versus subtotal abdominal hysterectomy. N Engl J Med. 2002 Oct 24;347(17):1318-25. doi: 10.1056/NEJMoa013336.
• Results Wald HL, Ma A, Bratzler DW, Kramer AM. Indwelling urinary catheter use in the postoperative period: analysis of the national surgical infection prevention project data. Arch Surg. 2008 Jun;143(6):551-7. doi: 10.1001/archsurg.143.6.551.

Drugs

Indications