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OpenTrials
Completed

NCT Number: NCT05798572

Pre-Op Sildosine and Ureteral Dilation During F-URS

We proposed that silodosin administration preoperatively may facilitate ureteral access sheath (UAS) placement prior to flexible ureteroscopy (F-URS) and decrease the incidence of ureteric injury in some difficult cases.

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Key information

Conditions

FURS Sildosine Ureteral Dilatation

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Benha University Hospitals

Banhā, Benha, 13511, Egypt

About this study

Urolithiasis is a common urological disorder in the world and has a significant effect on the global health system. The goal of treatment is to achieve the highest stone-free rate (SFR) with the least invasive. Per¬cutaneous nephrolithotomy and flexible ureterorenoscopy (F-URS) are the two main minimally invasive procedures for the treatment of upper urinary tract stones.

The challenging step in flexible ureterorenoscopy (F-URS) is ureteroscopic access sheath (UAS) placement, which facilitates fast and safe access to the ureter and collecting system; improves visibility; reduces the risk of infection by reducing intrarenal pressure. However, in some cases, the acute ureteric injury may occur during ureteroscopic access sheath (UAS) placement.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Upper ureteric stone or stone kidney (with stone burden equal to or less than 20mm).
  • 2. Non stented.
  • Age (Above 18 years old).

Exclusion criteria

  • Acute or chronic renal insufficiency.
  • Uncorrected coagulopathy.
  • Previous open (lumber or ureteric) surgery.
  • Active urinary tract infection unless treated.

Treatment and study plan

Sildosin group

Drug

Patients in this group had flexible ureteroscopy (F-URS) with preoperative daily uptake of 8 mg silodosin for one week.

Placebo/control group

Procedure

included 70 patients for whom flexible ureteroscopy (F-URS) was done with daily preoperative intake of placebo tablets.

Primary outcomes

  1. Entrance to bladder time (ETBT)

    Time frame: Intraoperatively

    Entrance to bladder time (ETBT) will be recorded

Secondary outcomes

  1. Entrance to ureteric orifice time (ETUOT)

    Time frame: Intraoperatively

    Entrance to ureteric orifice time (ETUOT) will be recorded

  2. Application of access sheath time (AAST)

    Time frame: Intraoperatively

    Application of access sheath time (AAST) will be recorded

Sponsors and collaborators

Lead sponsor

Benha University

Other

Registry information

Official study title

Is Preoperative Sildosine Adminstration Faciltate Ureteral Diltation During Flexible Ureterorenoscopy?

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Apr 4, 2023
Registry last updated
Jul 11, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.