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NCT Number: NCT05833386

Effect of Preoperative Silodosin on Feasibility of Ureteral Access Sheath Insertion

The ureteral access sheath (UAS) is an ancillary device widely used by urologists to facilitate fast, repeatable, and safe access to ureters and collecting systems; improve visibility; reduce the risk of infection by reducing intrarenal pressure; and protect ureters and scopes when extracting multiple stones during surgery.

Insertion of ureteric access sheath may be difficult due to tight ureter, so sometimes preoperative stenting might be needed. Silodosin is an α1A adrenoceptor with high affinity and selectivity for the ureteric muscle, which may reduce ureteral spasm.

Oral a1-blockers can reduce intraureteral pressure, and may reduce maximal ureteral access sheath insertion force.¹ Preoperative silodosin protects against significant ureteral injury related to UAS insertion during fURS and decreases postoperative pain level. Silodosin premedication might be an effective and safe technique to replace prestenting.²

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Key information

Conditions

Renal Stone Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Nephrolithiasis Urogenital Diseases Urolithiasis Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Urology department - AlAzhar university

Cairo, Egypt

Location status: Recruiting

Location contact

Mohamed F Salman, MD

CONTACT

[email protected]

+201111788996

Mohamed F Salman, MD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • All patients with renal stones who will undergo flexible ureteroscopy and planned for using ureteral access sheath

Exclusion criteria

  • Paediatric age group (less than 18 year)

Treatment and study plan

Ureteral access sheath placement during flexible ureteroscope for renal stones

Procedure

Ureteral access sheath placement during flexible ureteroscope

Primary outcomes

  1. failure rate of UAS insertion during FURS

    Time frame: 2 hours

Secondary outcomes

  1. Ureteral injuries after UAS insertion

    Time frame: 3 hours

    Ureter wall injury will be classified according to the following five grades:

    Grade 0: No lesion or only mucosal petechiae. Grade 1: Mucosal erosion or a mucosal flap without smooth muscle injury. Grade 2: Erosion involving the mucosa and smooth muscle but sparing the adventitia.

    Grade 3: Ureteral perforation involving the full thickness of the ureteral wall, including the adventitia.

    Grade 4: Total ureteral avulsion with a complete rupture of ureteral continuity.

  2. Post operative pain

    Time frame: 12 hours after surgery

    a visual analog scale (VAS) score (0 = no pain to 10 = excruciating pain) to indicate the intensity of postoperative pain 12 h after surgery.

  3. Complications related to the procedure

    Time frame: 3 months

    will be graded using the modified Clavien-Dindo classification system.

Sponsors and collaborators

Lead sponsor

Al-Azhar University

Other

Collaborators

  • Alexandria University
  • Benha University
  • Cairo University
  • Menoufia University
  • Tanta University

Registry information

Official study title

Effect of Preoperative Silodosin on Feasibility of Ureteral Access Sheath Insertion for Flexible Ureteroscope in Treating Renal Stones; A Prospective, Multicentre, Randomized Trial

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
Apr 27, 2023
Registry last updated
Aug 8, 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.

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