Optimal Intrarenal Pressure During Flexible Ureteroscopy

November 4, 2026 updated by: Mahmoud Elrefaey, Tanta University

Optimal Intrarenal Pressure During Flexible Ureteroscopy: A Randomized Controlled Trial of Pressure-Controlled Irrigation

The aim of this work is to determine the effect of different automated intrarenal pressure targets during retrograde intrarenal surgery (RIRS) on intrarenal pressure exposure and to identify the pressure target that provides the optimal balance between pressure control, surgical efficiency, and patient safety.

This study will compare manual hand-operated irrigation versus automated irrigation with intrarenal pressure targets of 20, 30 and 40 mmHg. The primary endpoint is the time-weighted IRP, and the key secondary endpoint is the postoperative complications.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

300

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age ≥18 years
  • Renal stones 20-30 mm
  • Indicated for F-URS
  • Pre-stenting

Exclusion Criteria:

  • Renal stones less than 20 mm
  • Pregnancy
  • Coagulopathy
  • Active UTI
  • Ureteral stricture
  • Solitary kidney (unless intentionally studying this subgroup)
  • Previous urinary diversion
  • Congenital anomalies preventing FURS

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: FURS with manual hand-operated irrigation
Procedure: FURS with manual irrigation

FURS with manual hand-operated irrigation
Experimental: FURS with automated IRP target of 20 mmHg
Procedure: FURS with automated irrigation (20 mmHg)

FURS with automated Intrarenal pressure target of 20 mmHg
Experimental: FURS with automated IRP target of 30 mmHg
Procedure: FURS with automated irrigation (30 mmHg)

FURS with automated Intrarenal pressure target of 30 mmHg
Experimental: FURS with automated IRP target of 40 mmHg
Procedure: FURS with automated irrigation (40 mmHg)

FURS with automated Intrarenal pressure target of 40 mmHg

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time-weighted mean IRP
Time Frame: Periprocedural

The average pressure inside the renal collecting system throughout a procedure, accounting for how long each pressure level persists
Periprocedural

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative infectious complications
Time Frame: Up to 4 weeks postoperatively

Postoperative fever, SIRS or sepsis
Up to 4 weeks postoperatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tanta University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

November 1, 2026

Primary Completion (Estimated)

September 30, 2028

Study Completion (Estimated)

October 31, 2028

Study Registration Dates

First Submitted

October 26, 2026

First Submitted That Met QC Criteria

November 4, 2026

First Posted (Actual)

November 6, 2026

Study Record Updates

Last Update Posted (Actual)

November 6, 2026

Last Update Submitted That Met QC Criteria

November 4, 2026

Last Verified

November 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

  • 36265PR225/9/26

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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