UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000034067
Receipt number R000038819
Scientific Title A prospective randomized controlled trial comparing a ureteral stent crossing versus not crossing the bladder midline
Date of disclosure of the study information 2018/10/01
Last modified on 2021/11/29 16:37:31

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Basic information

Public title

A prospective randomized controlled trial comparing a ureteral stent crossing versus not crossing the bladder midline

Acronym

NOTCROSS trial

Scientific Title

A prospective randomized controlled trial comparing a ureteral stent crossing versus not crossing the bladder midline

Scientific Title:Acronym

NOTCROSS trial

Region

Japan


Condition

Condition

Ureteric and renal stones

Classification by specialty

Urology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To prospectively compare the influence of ureteral stent position in the bladder on urinary symptoms.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Others

Developmental phase

Not applicable


Assessment

Primary outcomes

Difference in the change in the total points of IPSS and OABSS before and after ureteral stent placement between two groups.

Key secondary outcomes

1. Difference in change amount of each item of IPSS
2. Difference in change amount of each item of OABSS
3. Can it be a useful indicator when choosing a ureteral stent whose height is appropriate?
4. Difference in pain due to ureteral stent during ureteral stent placement


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Maneuver

Interventions/Control_1

A group that ureteral stent tail is left inside the bladder without crossing the midline.

Interventions/Control_2

A group that ureteral stent tail is left inside the bladder crossing the midline.

Interventions/Control_3


Interventions/Control_4


Interventions/Control_5


Interventions/Control_6


Interventions/Control_7


Interventions/Control_8


Interventions/Control_9


Interventions/Control_10



Eligibility

Age-lower limit

20 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

1, Over 20 years old
2. Patients who can describe the questionnaire
3. Patients who can understand this study
4, patients undergoing TUL for upper urinary calculi

Key exclusion criteria

1) Active urinary tract infection
2) Concomitant medication with alpha blockers, antimuscarinics, analgesics, beta-3 agonist, PDE 5 inhibitor
3) Pregnancy
8) Ureteral stent placement before TUL
9) Bilateral ureteral stenting
10) Bladder cancer
11) Prostate cancer
12) Neurogenic bladder
13) Chronic prostatitis
14) Complications during ureteroscopy such as ureteral perforation
15) Lower ureteral calculi

Target sample size

128


Research contact person

Name of lead principal investigator

1st name Makoto
Middle name
Last name Taguchi

Organization

Osaka Saiseikai Izuo Hospital

Division name

Department of Urology

Zip code

551-0032

Address

3-4-5, Kitamura, Taisho-ku, Osaka

TEL

06-6552-0091

Email

taguchim@takii.kmu.ac.jp


Public contact

Name of contact person

1st name Makoto
Middle name
Last name Taguchi

Organization

Osaka Saiseikai Izuo Hospital

Division name

Department of Urology

Zip code

551-0032

Address

3-4-5, Kitamura, Taisho-ku, Osaka

TEL

06-6552-0091

Homepage URL


Email

taguchim@takii.kmu.ac.jp


Sponsor or person

Institute

Osaka Saiseikai Izuo Hospital

Institute

Department

Personal name



Funding Source

Organization

None

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Osaka Saiseikai Izuo Hospital

Address

3-4-5, Kitamura, Taisho-ku, Osaka

Tel

06-6552-0091

Email

taguchim@takii.kmu.ac.jp


Secondary IDs

Secondary IDs

NO

Study ID_1


Org. issuing International ID_1


Study ID_2


Org. issuing International ID_2


IND to MHLW



Institutions

Institutions



Other administrative information

Date of disclosure of the study information

2018 Year 10 Month 01 Day


Related information

URL releasing protocol


Publication of results

Published


Result

URL related to results and publications


Number of participants that the trial has enrolled

113

Results

Comparing changes from baseline IPSS and OABSS scores between the two groups, the crossing midline group had a worse OABSS total score than the not crossing group (3.0 +- 2.8 vs 2.0 +- 3.3, respectively; p = 0.032). There was no significant difference between the crossing vs not crossing groups in the IPSS total score (6.8 +- 7.6 vs 5.1 +- 8.5, respectively; p = 0.14).

Results date posted

2021 Year 11 Month 29 Day

Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics


Participant flow


Adverse events


Outcome measures


Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Completed

Date of protocol fixation

2018 Year 10 Month 01 Day

Date of IRB

2018 Year 09 Month 24 Day

Anticipated trial start date

2018 Year 10 Month 01 Day

Last follow-up date

2020 Year 12 Month 14 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2018 Year 09 Month 08 Day

Last modified on

2021 Year 11 Month 29 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038819


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name
2021/11/29 ステント関連症状 データベース 解析用 UMIN用.xlsx