Comparing Treatment of Urolithiasis Between Disposable and Reusable Ureteroscope

• Sponsor: University of California, San Francisco (Other)
• Overall Status: Completed
• CT.gov ID: NCT03040466
• Collaborator: (none)
• Enrollment: 180
• Location: 1
• Arms: 2
• Actual Duration (Months): 25
• Patients Per Site Per Month: 7.2

Study Details

Study Description

Brief Summary

Reusable flexible ureteroscopes are widely used to treat various upper urinary tract diseases including urinary stones. However, they require a long turnover time between procedures because of the sterilization process. Moreover, repeated use of a scope ultimately deteriorates its image quality which leads to a high maintenance cost in the long-term. A disposable digital flexible ureteroscope was released in the United States in January 2016, offering an improved image resolution, new scope performance characteristics with every case, and no need for sterilization and repair. Preliminary data from our center has demonstrated that disposable scopes shorten operative time by 25% compared to reusable fiberoptic scope and are associated with a 2/3 reduction in procedural complication rate. Therefore, treatment with disposable scopes may be more effective for patients and facilitate cost management within the hospital.

Here, we propose a three-armed, prospective randomized study, comparing treatment outcomes between disposable digital, reusable fiberoptic, and reusable digital flexible ureteroscopes.

Condition or Disease	Intervention/Treatment	Phase
Kidney Calculi; Ureter Calculi	Device: reusable fiberoptic ureteroscope; Device: disposable digital ureteroscope	N/A

Detailed Description

This is a single center, prospective, randomized controlled pragmatic clinical trial designed to compare between disposable, reusable fiberoptic, and reusable digital ureteroscopes in upper urinary tract stone treatment efficacy. Three hundred subjects with kidney and/or ureteral stones are planned to recruit for the study. All subjects will be computer sequence-randomized into having their ureteroscopic treatment performed with a disposable (LithoVue™), reusable fiberoptic (URF-P6™), or reusable digital (URF-V2™) flexible ureteroscope. Patient's demographics, physical, laboratory, and image findings will be collected before surgery. These clinical data are already being collected as part of an ongoing registry study. Perioperative timing as well as operator's satisfaction and fatigue and need for a second ureteroscope during the case will be recorded during the treatment course. Other clinical data will be collected at days 7, 30, 90, 180 after surgery. The condition of the used ureteroscopes will be tracked and recorded to confirm the repair rate.

Screening data will be reviewed to determine subject eligibility. Subjects who meet all inclusion criteria and none of the exclusion criteria will be entered into the study.

The following surgical treatment will be used similarly for all three randomized arms and represents standard of case therapy:

Ureteroscopic stone removal Under general anesthesia, the patient is placed in the lithotomy position. All procedures are performed under direct videoscopic and fluoroscopic guidance. Fluoroscopic screening is utilized using a mobile multidirectional C-arm fluoroscopy unit. Initially, a safety guide-wire is placed into the renal pelvis, followed by a ureteral access sheath as needed to maintain low intra-renal pressure and to facilitate the procedures. Using a flexible ureteroscope, renal or ureteral stones are identified and fragmented with a holmium YAG laser. Basket extraction of residual fragments is done until visual complete clearance of stone fragments is achieved.

After ureteroscopy is done and stone clearance is achieved, a ureteral stent is placed at the end of the procedure to drain the kidney for 2-21 days if it is clinically indicated.

The total duration of the study is expected to be one year for subject recruitment and one year and six months for final subject follow-up.

Study Design

• Study Type: Interventional
• Actual Enrollment: 180 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Participants will be assigned to each 3 type of ureteroscope and receive the flexible ureteroscopy. In each ureteroscopy, only one type of ureteroscope will be used; therefore this study will be parallel model.Participants will be assigned to each 3 type of ureteroscope and receive the flexible ureteroscopy. In each ureteroscopy, only one type of ureteroscope will be used; therefore this study will be parallel model.
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Randomized Controlled Trial Comparing Disposable to Reusable Flexible Ureteroscope for Treatment of Upper Urinary Tract Stone
• Actual Study Start Date: Aug 1, 2014
• Actual Primary Completion Date: Sep 1, 2016
• Actual Study Completion Date: Sep 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: reusable fiberoptic ureteroscope For this arm, participants will receive the ureteroscopy for their kidney and ureter stones using reusable fiberoptic flexible ureteroscope (URF-P6, Olympus). The surgical method of the ureteroscopy will be a standard fashion same as other arms.	Device: reusable fiberoptic ureteroscope; We will use reusable fiberoptic ureteroscopes for the treatment of kidney and ureter stones.
Experimental: disposable digital ureteroscope For this arm, participants will receive the ureteroscopy for their kidney and ureter stones using disposable digital flexible ureteroscope (LithoVue, Boston Scientific). The surgical method of the ureteroscopy will be a standard fashion same as other arms.	Device: disposable digital ureteroscope; We will use disposable digital ureteroscopes for the treatment of kidney and ureter stones.

Outcome Measures

Primary Outcome Measures

1. Overall Procedure Time [at the surgery day, this will be a duration that each ureteroscopy is performed for a patient, assessed between 10 and 120 minutes]

Secondary Outcome Measures

1. Number of Participants That Are Stone Free [three month after surgery]

   this will be determined by either CT, US, or KUB

2. Number of Participants With Complications [from during the surgery to three months after the surgery]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. Male or female ≥ 18 years of age at their first clinical visit.

2. Patients with either unilateral or bilateral upper urinary tract stone of any size and location, treatable by flexible ureteroscopy, diagnosed by preoperative ultrasound, computed tomography or plain radiographic imaging

3. Patients being able and willing to provide consent.

Exclusion Criteria:

1. Serious illness likely to cause death within the next 5 years, so as to exclude significant metabolic derangements that might lead to adverse surgical outcome.

2. Pregnancy.

3. Staged ureteroscopic procedure.

4. Antegrade flexible ureteroscopy.

5. Dual procedures (ureteroscopy concurrently performed with other operations).

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of California, San Francisco	San Francisco	California	United States	94143

Sponsors and Collaborators

• University of California, San Francisco

Investigators

• Principal Investigator: Thomas Chi, MD, Urology, University of California San Francisco

Study Documents (Full-Text)

None provided.

More Information

Publications

• Butticè S, Sener TE, Netsch C, Emiliani E, Pappalardo R, Magno C. LithoVue™: A new single-use digital flexible ureteroscope. Cent European J Urol. 2016;69(3):302-305. Epub 2016 Aug 26.
• Carey RI, Martin CJ, Knego JR. Prospective evaluation of refurbished flexible ureteroscope durability seen in a large public tertiary care center with multiple surgeons. Urology. 2014 Jul;84(1):42-5. doi: 10.1016/j.urology.2014.01.022. Epub 2014 May 14.
• de la Rosette J, Denstedt J, Geavlete P, Keeley F, Matsuda T, Pearle M, Preminger G, Traxer O; CROES URS Study Group. The clinical research office of the endourological society ureteroscopy global study: indications, complications, and outcomes in 11,885 patients. J Endourol. 2014 Feb;28(2):131-9. doi: 10.1089/end.2013.0436. Epub 2013 Dec 17.
• Doizi S, Kamphuis G, Giusti G, Andreassen KH, Knoll T, Osther PJ, Scoffone C, Pérez-Fentes D, Proietti S, Wiseman O, de la Rosette J, Traxer O. First clinical evaluation of a new single-use flexible ureteroscope (LithoVue™): a European prospective multicentric feasibility study. World J Urol. 2017 May;35(5):809-818. doi: 10.1007/s00345-016-1936-x. Epub 2016 Sep 26.
• Geavlete P, Multescu R, Geavlete B. Pushing the boundaries of ureteroscopy: current status and future perspectives. Nat Rev Urol. 2014 Jul;11(7):373-82. doi: 10.1038/nrurol.2014.118. Epub 2014 Jun 3. Review.
• Healy KA, Pak RW, Cleary RC, Colon-Herdman A, Bagley DH. Hand problems among endourologists. J Endourol. 2011 Dec;25(12):1915-20. doi: 10.1089/end.2011.0128. Epub 2011 Oct 17.
• Karaolides T, Bach C, Kachrilas S, Goyal A, Masood J, Buchholz N. Improving the durability of digital flexible ureteroscopes. Urology. 2013 Apr;81(4):717-22. doi: 10.1016/j.urology.2013.01.016. Epub 2013 Mar 7.
• Martin CJ, McAdams SB, Abdul-Muhsin H, Lim VM, Nunez-Nateras R, Tyson MD, Humphreys MR. The Economic Implications of a Reusable Flexible Digital Ureteroscope: A Cost-Benefit Analysis. J Urol. 2017 Mar;197(3 Pt 1):730-735. doi: 10.1016/j.juro.2016.09.085. Epub 2016 Sep 28.
• Multescu R, Geavlete B, Geavlete P. A new era: performance and limitations of the latest models of flexible ureteroscopes. Urology. 2013 Dec;82(6):1236-9. doi: 10.1016/j.urology.2013.07.022. Epub 2013 Aug 28.
• Somani BK, Al-Qahtani SM, de Medina SD, Traxer O. Outcomes of flexible ureterorenoscopy and laser fragmentation for renal stones: comparison between digital and conventional ureteroscope. Urology. 2013 Nov;82(5):1017-9. doi: 10.1016/j.urology.2013.07.017. Epub 2013 Aug 31.
• Tosoian JJ, Ludwig W, Sopko N, Mullins JK, Matlaga BR. The effect of repair costs on the profitability of a ureteroscopy program. J Endourol. 2015 Apr;29(4):406-9. doi: 10.1089/end.2014.0435. Epub 2014 Nov 7.

• Responsible Party: University of California, San Francisco
• ClinicalTrials.gov Identifier: NCT03040466
• Other Study ID Numbers: 16-20844
• First Posted: Feb 2, 2017
• Last Update Posted: Oct 1, 2020
• Last Verified: Sep 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: No
• Keywords provided by University of California, San Francisco: ureteroscopy; flexible ureteroscope; randomized controlled trial
• Additional relevant MeSH terms: Kidney Calculi; Nephrolithiasis; Calculi

Study Results

Participant Flow

Arm/Group Title	Reusable Fiberoptic Ureteroscope	Disposable Digital Ureteroscope
Arm/Group Description	For this arm, participants will receive the ureteroscopy for their kidney and ureter stones using reusable fiberoptic flexible ureteroscope (URF-P6, Olympus). The surgical method of the ureteroscopy will be a standard fashion same as other arms. reusable fiberoptic ureteroscope: We will use reusable fiberoptic ureteroscopes for the treatment of kidney and ureter stones.	For this arm, participants will receive the ureteroscopy for their kidney and ureter stones using disposable digital flexible ureteroscope (LithoVue, Boston Scientific). The surgical method of the ureteroscopy will be a standard fashion same as other arms. disposable digital ureteroscope: We will use disposable digital ureteroscopes for the treatment of kidney and ureter stones.
Period Title: Overall Study
STARTED	65	115
COMPLETED	65	115
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Reusable Fiberoptic Ureteroscope	Disposable Digital Ureteroscope	Total
Arm/Group Description	For this arm, participants will receive the ureteroscopy for their kidney and ureter stones using reusable fiberoptic flexible ureteroscope (URF-P6, Olympus). The surgical method of the ureteroscopy will be a standard fashion same as other arms. reusable fiberoptic ureteroscope: We will use reusable fiberoptic ureteroscopes for the treatment of kidney and ureter stones.	For this arm, participants will receive the ureteroscopy for their kidney and ureter stones using disposable digital flexible ureteroscope (LithoVue, Boston Scientific). The surgical method of the ureteroscopy will be a standard fashion same as other arms. disposable digital ureteroscope: We will use disposable digital ureteroscopes for the treatment of kidney and ureter stones.	Total of all reporting groups
Overall Participants	65	115	180
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	50.5 (12.6)	55.8 (15.1)	53.8 (14.4)
Sex: Female, Male (Count of Participants)
Female	34 52.3%	54 47%	88 48.9%
Male	31 47.7%	61 53%	92 51.1%
Region of Enrollment (Count of Participants)
United States	65 100%	115 100%	180 100%

Outcome Measures

1. Primary Outcome

Title	Overall Procedure Time
Time Frame	at the surgery day, this will be a duration that each ureteroscopy is performed for a patient, assessed between 10 and 120 minutes

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Reusable Fiberoptic Ureteroscope	Disposable Digital Ureteroscope
Arm/Group Description	For this arm, participants will receive the ureteroscopy for their kidney and ureter stones using reusable fiberoptic flexible ureteroscope (URF-P6, Olympus). The surgical method of the ureteroscopy will be a standard fashion same as other arms. reusable fiberoptic ureteroscope: We will use reusable fiberoptic ureteroscopes for the treatment of kidney and ureter stones.	For this arm, participants will receive the ureteroscopy for their kidney and ureter stones using disposable digital flexible ureteroscope (LithoVue, Boston Scientific). The surgical method of the ureteroscopy will be a standard fashion same as other arms. disposable digital ureteroscope: We will use disposable digital ureteroscopes for the treatment of kidney and ureter stones.
Measure Participants	65	115
Mean (Standard Deviation) [minutes]	64.5 (37.0)	54.1 (25.7)

2. Secondary Outcome

Title	Number of Participants That Are Stone Free
Description	this will be determined by either CT, US, or KUB
Time Frame	three month after surgery

Outcome Measure Data

Analysis Population Description

Postoperative imaging was requested of all patients, but the total study group did not follow up with kidney, ureter, and bladder radiograph or ultrasound surveillance imaging. Participants with post operative imaging included here.

Arm/Group Title	Reusable Fiberoptic Ureteroscope	Disposable Digital Ureteroscope
Arm/Group Description	For this arm, participants will receive the ureteroscopy for their kidney and ureter stones using reusable fiberoptic flexible ureteroscope (URF-P6, Olympus). The surgical method of the ureteroscopy will be a standard fashion same as other arms. reusable fiberoptic ureteroscope: We will use reusable fiberoptic ureteroscopes for the treatment of kidney and ureter stones.	For this arm, participants will receive the ureteroscopy for their kidney and ureter stones using disposable digital flexible ureteroscope (LithoVue, Boston Scientific). The surgical method of the ureteroscopy will be a standard fashion same as other arms. disposable digital ureteroscope: We will use disposable digital ureteroscopes for the treatment of kidney and ureter stones.
Measure Participants	38	40
Count of Participants [Participants]	17 26.2%	24 20.9%

3. Secondary Outcome

Title	Number of Participants With Complications
Time Frame	from during the surgery to three months after the surgery

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Reusable Fiberoptic Ureteroscope	Disposable Digital Ureteroscope
Arm/Group Description	For this arm, participants will receive the ureteroscopy for their kidney and ureter stones using reusable fiberoptic flexible ureteroscope (URF-P6, Olympus). The surgical method of the ureteroscopy will be a standard fashion same as other arms. reusable fiberoptic ureteroscope: We will use reusable fiberoptic ureteroscopes for the treatment of kidney and ureter stones.	For this arm, participants will receive the ureteroscopy for their kidney and ureter stones using disposable digital flexible ureteroscope (LithoVue, Boston Scientific). The surgical method of the ureteroscopy will be a standard fashion same as other arms. disposable digital ureteroscope: We will use disposable digital ureteroscopes for the treatment of kidney and ureter stones.
Measure Participants	65	115
Count of Participants [Participants]	9 13.8%	9 7.8%

Adverse Events

Arm/Group Title	Reusable Fiberoptic Ureteroscope		Disposable Digital Ureteroscope
Arm/Group Description	For this arm, participants will receive the ureteroscopy for their kidney and ureter stones using reusable fiberoptic flexible ureteroscope (URF-P6, Olympus). The surgical method of the ureteroscopy will be a standard fashion same as other arms. reusable fiberoptic ureteroscope: We will use reusable fiberoptic ureteroscopes for the treatment of kidney and ureter stones.		For this arm, participants will receive the ureteroscopy for their kidney and ureter stones using disposable digital flexible ureteroscope (LithoVue, Boston Scientific). The surgical method of the ureteroscopy will be a standard fashion same as other arms. disposable digital ureteroscope: We will use disposable digital ureteroscopes for the treatment of kidney and ureter stones.
All Cause Mortality
	Reusable Fiberoptic Ureteroscope		Disposable Digital Ureteroscope
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/65 (0%)		0/115 (0%)
Serious Adverse Events
	Reusable Fiberoptic Ureteroscope		Disposable Digital Ureteroscope
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/65 (0%)		0/115 (0%)
Other (Not Including Serious) Adverse Events
	Reusable Fiberoptic Ureteroscope		Disposable Digital Ureteroscope
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	9/65 (13.8%)		9/115 (7.8%)
Surgical and medical procedures
Presence of postoperative complications	9/65 (13.8%)		9/115 (7.8%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.