Efficacy and Safety of Ureteroscopic Lithotripsy (Including Flexible Ureteroscopy) Without Indwelling Urinary Catheter

NCT ID: NCT06458101

Last Updated: 2025-11-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

180 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-07-01

Study Completion Date

2025-06-30

Brief Summary

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A prospective, multicenter, randomized, controlled clinical trial was conducted to compare the efficacy and safety of non-indwelling catheter and indwelling catheter in relieving postoperative catheter-related complications after ureteroscopic lithotripsy. By comparing the pain score and urination urgency score (PPIUS) of patients after ureteroscopic lithotripsy (including flexible ureteroscopy) lithotripsy to provide a reliable scientific basis for indwelling catheter after ureteroscopic lithotripsy.

Detailed Description

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Conditions

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Urolithiasis Catheter-related Bladder Discomfort

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Group 1: Ureteroscopy (including flexible endoscope) lithotripsy with indwelling urinary catheter

Ureteroscopy (including flexible endoscope) lithotripsy with indwelling urinary catheter

Group Type ACTIVE_COMPARATOR

Ureteroscopy (including flexible endoscope) lithotripsy with indwelling urinary catheter

Intervention Type PROCEDURE

Ureteroscopy (including flexible endoscope) lithotripsy with indwelling urinary catheter

Group 2: Ureteroscopy (including flexible endoscope) lithotripsy without indwelling urinary catheter

Ureteroscopy (including flexible endoscope) lithotripsy without indwelling urinary catheter

Group Type EXPERIMENTAL

Ureteroscopy (including flexible endoscope) lithotripsy without indwelling urinary catheter

Intervention Type PROCEDURE

Ureteroscopy (including flexible endoscope) lithotripsy without indwelling urinary catheter

Interventions

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Ureteroscopy (including flexible endoscope) lithotripsy without indwelling urinary catheter

Ureteroscopy (including flexible endoscope) lithotripsy without indwelling urinary catheter

Intervention Type PROCEDURE

Ureteroscopy (including flexible endoscope) lithotripsy with indwelling urinary catheter

Ureteroscopy (including flexible endoscope) lithotripsy with indwelling urinary catheter

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Patients with upper urinary tract calculi undergoing rigid ureteroscopic and soft ureteroscopic lithotripsy;
* Normal renal function;
* Aged between 18 and 70 years old
* Complete the operation under general anesthesia

Exclusion Criteria

* Solitary kidney;
* Previous history of renal transplantation or urinary diversion;
* Congenital malformation of urinary system;
* Abnormal coagulation mechanism due to blood system diseases, liver diseases, etc.
* Severe heart or lung disease, Malignant tumor and immunodeficiency state
* Urethral stricture
* Neurogenic bladder
* Operation under epidural anesthesia or spinal anesthesia
* Large amount of bleeding during operation should be observed by indwelling catheter to observe urine color
* High risk factors such as large amount of pus fur should be observed during operation.
* Urethral injury during operation leads to false passage
* Operation time is more than 90 minutes. Higher risk of bleeding or infection
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

OTHER

Sponsor Role lead

Responsible Party

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Yi Shao

Director

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Shanghai General Hospital

Shanghai, Shanghai Municipality, China

Site Status

Countries

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China

Other Identifiers

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IIT2024-050

Identifier Type: -

Identifier Source: org_study_id

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