The Use of Dye-less Cystoscopy in Assessing Urinary Tract Integrity During Hysterectomy

NCT05190939 | Completed

• 1 other identifier: 1236245-7
• Study Type: interventional
• Target: 276
• Locations: 1 country
• Sites: 1

Brief Summary

An investigation comparing the reliability of dye-aided versus dye-less evaluation of urinary tract integrity during intra-operative cystoscopy among patients undergoing hysterectomy.

Conditions

Hysterectomy; Cystoscopy

Keywords

hysterectomy; universal cystoscopy; cystoscopy

Outcome Measures

Primary Outcomes (1)

• Inter-observer correlation of urine efflux strength during cystoscopy

  Observers visually assess ureters on-screen simultaneously and independently. Ureteral jet efflux from each ureter is assigned a score on a linear visual scale from 0 to 5. The best of three scores of three consecutive jets from each ureter is assigned as the strength of ureteral jet. On a continuous visual scale, absent efflux is assigned as zero, slow or impaired efflux is assigned up to a score of 2, average flow neither sluggish nor brisk is assigned at least 2, and brisk flow is assigned a score of at least 3 and up to a score of 5. Evaluators determine if efflux is greater than 2. If so, evaluators are instructed to determine if efflux is 3 or 5- jets scored as 3 represent regular stream flow with no intermittent breaks and jets scored as 5 represented continuous strong flow. A score of 4 is given if the urine jet flow did not meet the criteria for a scoring of 3 or 5. Correlation of score agreement between observers and group assignments is then determined.

  at time of cystoscopy

Secondary Outcomes (2)

• Comparison of ureteral jet strength between groups based group assignment

  at time of cystoscopy

• Ureteral jet time

  at time of cystoscopy

Study Arms (4)

no-dye/saline

ACTIVE COMPARATOR

Subjects assigned to the no-dye/saline group will have cystoscopy performed using saline as the bladder distending media and will not utilize any intravenous dye

Diagnostic Test: No intervention

dye/saline

EXPERIMENTAL

Subjects assigned to the dye/saline group will have cystoscopy performed using saline as the bladder distending media and will utilize intravenous dye (methylene blue or fluorescein) as a ureteral jet visualization aid

Diagnostic Test: intravenous dye

no-dye/water

EXPERIMENTAL

Subjects assigned to the no-dye/water group will have cystoscopy performed using water as the bladder distending media and will not utilize any intravenous dye

Diagnostic Test: water as bladder distending media

dye/water

EXPERIMENTAL

Subjects assigned to the dye/water group will have cystoscopy performed using water as the bladder distending media and will utilize intravenous dye (methylene blue or fluorescein) as a ureteral jet visualization aid

Diagnostic Test: water as bladder distending media; Diagnostic Test: intravenous dye

Interventions

water as bladder distending media DIAGNOSTIC_TEST

water will be used for bladder dissension during cystoscopy

dye/water; no-dye/water

intravenous dye DIAGNOSTIC_TEST

intravenous dye using methylene blue or fluorescein will be used for visual aid of ureteral jets during cystoscopy

dye/saline; dye/water

No intervention DIAGNOSTIC_TEST

Saline only, no dye

no-dye/saline

Eligibility Criteria

• Age: 18 Years - 90 Years
• Gender Eligibility Details: Female patients undergoing hysterectomy
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects at least 18 years of age and less than 90 years of age able to give informed consent
• Subjects undergoing hysterectomy for benign or malignant indications

You may not qualify if:

• Pregnancy or planned fertility
• Inability to provide informed consent
• Subject is not a surgical candidate

Sponsors & Collaborators

• WellSpan Health: lead

Study Sites (1)

Wellspan Health

York, Pennsylvania, 17403, United States

Location

Related Publications (18)

• Ibeanu OA, Chesson RR, Echols KT, Nieves M, Busangu F, Nolan TE. Urinary tract injury during hysterectomy based on universal cystoscopy. Obstet Gynecol. 2009 Jan;113(1):6-10. doi: 10.1097/AOG.0b013e31818f6219.

  PMID: 19104353 BACKGROUND

• Dowling RA, Corriere JN Jr, Sandler CM. Iatrogenic ureteral injury. J Urol. 1986 May;135(5):912-5. doi: 10.1016/s0022-5347(17)45921-0.

  PMID: 3959239 BACKGROUND

• Chou MT, Wang CJ, Lien RC. Prophylactic ureteral catheterization in gynecologic surgery: a 12-year randomized trial in a community hospital. Int Urogynecol J Pelvic Floor Dysfunct. 2009 Jun;20(6):689-93. doi: 10.1007/s00192-008-0788-3. Epub 2009 Jan 23.

  PMID: 19165412 BACKGROUND

• Redan JA, McCarus SD. Protect the ureters. JSLS. 2009 Apr-Jun;13(2):139-41.

  PMID: 19660205 BACKGROUND

• Frankel J. Accuracy of cystoscopy in the diagnosis of ureteral injury in benign gynecologic surgery. Int Urogynecol J Pelvic Floor Dysfunct. 2004 Mar-Apr;15(2):75. doi: 10.1007/s00192-004-1144-x. Epub 2004 Feb 20. No abstract available.

  PMID: 15014932 BACKGROUND

• Gilmour DT, Das S, Flowerdew G. Rates of urinary tract injury from gynecologic surgery and the role of intraoperative cystoscopy. Obstet Gynecol. 2006 Jun;107(6):1366-72. doi: 10.1097/01.AOG.0000220500.83528.6e.

  PMID: 16738165 BACKGROUND

• Teeluckdharry B, Gilmour D, Flowerdew G. Urinary Tract Injury at Benign Gynecologic Surgery and the Role of Cystoscopy: A Systematic Review and Meta-analysis. Obstet Gynecol. 2015 Dec;126(6):1161-1169. doi: 10.1097/AOG.0000000000001096.

  PMID: 26551173 BACKGROUND

• Barber EL, Polan RM, Strohl AE, Siedhoff MT, Clarke-Pearson DL. Cystoscopy at the Time of Hysterectomy for Benign Indications and Delayed Lower Genitourinary Tract Injury. Obstet Gynecol. 2019 May;133(5):888-895. doi: 10.1097/AOG.0000000000003192.

  PMID: 30969213 BACKGROUND

• American College of Obstetricians and Gynecologists. ACOG Committee Opinion. Number 372. July 2007. The Role of cystourethroscopy in the generalist obstetrician-gynecologist practice. Obstet Gynecol. 2007 Jul;110(1):221-224. doi: 10.1097/01.AOG.0000263916.77694.20.

  PMID: 17601926 BACKGROUND

• Visco AG, Taber KH, Weidner AC, Barber MD, Myers ER. Cost-effectiveness of universal cystoscopy to identify ureteral injury at hysterectomy. Obstet Gynecol. 2001 May;97(5 Pt 1):685-92. doi: 10.1016/s0029-7844(01)01193-0.

  PMID: 11339916 BACKGROUND

• Vakili B, Chesson RR, Kyle BL, Shobeiri SA, Echols KT, Gist R, Zheng YT, Nolan TE. The incidence of urinary tract injury during hysterectomy: a prospective analysis based on universal cystoscopy. Am J Obstet Gynecol. 2005 May;192(5):1599-604. doi: 10.1016/j.ajog.2004.11.016.

  PMID: 15902164 BACKGROUND

• Espaillat-Rijo L, Siff L, Alas AN, Chadi SA, Zimberg S, Vaish S, Davila GW, Barber M, Hurtado EA. Intraoperative Cystoscopic Evaluation of Ureteral Patency: A Randomized Controlled Trial. Obstet Gynecol. 2016 Dec;128(6):1378-1383. doi: 10.1097/AOG.0000000000001750.

  PMID: 27824741 BACKGROUND

• Siff LN, Unger CA, Jelovsek JE, Paraiso MF, Ridgeway BM, Barber MD. Assessing ureteral patency using 10% dextrose cystoscopy fluid: evaluation of urinary tract infection rates. Am J Obstet Gynecol. 2016 Jul;215(1):74.e1-6. doi: 10.1016/j.ajog.2016.02.006. Epub 2016 Feb 12.

  PMID: 26875949 BACKGROUND

• Grimes CL, Patankar S, Ryntz T, Philip N, Simpson K, Truong M, Young C, Advincula A, Madueke-Laveaux OS, Walters R, Ananth CV, Kim JH. Evaluating ureteral patency in the post-indigo carmine era: a randomized controlled trial. Am J Obstet Gynecol. 2017 Nov;217(5):601.e1-601.e10. doi: 10.1016/j.ajog.2017.07.012. Epub 2017 Jul 18.

  PMID: 28729014 BACKGROUND

• Propst K, Tunitsky-Bitton E, O'Sullivan DM, Steinberg AC, LaSala C. Phenazopyridine for Evaluation of Ureteral Patency: A Randomized Controlled Trial. Obstet Gynecol. 2016 Aug;128(2):348-355. doi: 10.1097/AOG.0000000000001472.

  PMID: 27399998 BACKGROUND

• Strom EM, Chaudhry ZQ, Guo R, Maisonet AJ, Holschneider CH, Wieslander CK. Effectiveness of Assessing Ureteral Patency Using Preoperative Phenazopyridine. Female Pelvic Med Reconstr Surg. 2019 Jul/Aug;25(4):289-293. doi: 10.1097/SPV.0000000000000540.

  PMID: 29300258 BACKGROUND

• Hui JYC, Harvey MA, Johnston SL. Confirmation of ureteric patency during cystoscopy using phenazopyridine HCl: a low-cost approach. J Obstet Gynaecol Can. 2009 Sep;31(9):845-849. doi: 10.1016/S1701-2163(16)34303-1.

  PMID: 19941709 BACKGROUND

• Cohen SA, Chaudhry Z, Oliver JL, Kreydin EI, Nguyen MT, Mills SA, Ackerman AL, Kim JH, Tarnay CM, Raz S. Comparison of Times to Ureteral Efflux after Administration of Sodium Fluorescein and Phenazopyridine. J Urol. 2017 Feb;197(2):519-523. doi: 10.1016/j.juro.2016.07.099. Epub 2016 Sep 21.

  PMID: 27664579 BACKGROUND

MeSH Terms

Interventions

Drinking Water

Intervention Hierarchy (Ancestors)

Water; Hydroxides; Alkalies; Inorganic Chemicals; Anions; Ions; Electrolytes; Oxides; Oxygen Compounds; Beverages; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Okechukwu Ibeanu, MD

  WellSpan Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Site Director, Gynecology Oncology

Model Details: Patients undergoing hysterectomy are randomized to one of 4 study arms for cystoscopy: 1) dye/saline 2) dye/water 3) no-dye/saline and 4) no-dye/water

Study Record Dates

• First Submitted: December 9, 2021
• First Posted: January 13, 2022
• Study Start: July 1, 2018
• Primary Completion: December 29, 2019
• Study Completion: December 29, 2019
• Last Updated: March 17, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)