Silodosin in Facilitating Flexible Uretroscopy

Ain Shams University

Status: Active, not recruiting

Conditions: Stone, Kidney; Stone Ureter

Treatments: Procedure: ureteric access sheath insertion in RIRS without silodosin (Placebo); Procedure: Preoperative sioldosin to facilitate ureteric access sheath insertion in RIRS

Study type: Interventional

Funder types: Other

Identifiers

NCT07068087

FMASU MS 766/2024

Details and patient eligibility

About

This study aims to provide robust evidence on whether a specific, potent pre-operative medication (silodosin) can make the critical step of ureteral access (UAS placement after dilation) easier and safer during f-URS for kidney stones in non-stented patients, potentially reducing complications and the need for pre-stenting.

Full description

This study specifically evaluates the effect of administering pre-operative silodosin (8mg daily for one week) on facilitating ureteral dilation prior to ureteral access sheath (UAS) placement during flexible ureteroscopy (f-URS), aiming to leverage the drug's potent ureteral smooth muscle relaxation to ease mechanical dilation with Teflon dilators (6-14Fr) and subsequent UAS insertion. Its primary endpoint directly measures the ease of UAS placement (categorized as smooth, resistant, or failed) after sequential dilation. To objectively assess safety, post-operative diagnostic ureteroscopy by a second surgeon grades ureteral wall injuries using a specific 5-grade scale. Employing a rigorous randomized, placebo-controlled trial (RCT) design with strict criteria (non-stented patients, stone burden 1-2 cm, no prior interventions), the study also evaluates secondary outcomes including ureteral injury severity, stone-free rates (SFR), post-operative pain (VAS), complications, hospital stay length, and medication side effects.

Enrollment: 42 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• adult male or female
• single renal or ureteric stone
• 1 to 2 cm in size.

Exclusion criteria

• pregnant women
• Untreated urinary tract infections
• Uncorrected bleeding disorders or coagulopathies
• Bilateral ureteric stones or multiple ipsilateral ureteric stones
• ureteral stricture,
• Patients who had previous ureteric stenting

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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42 participants in 2 patient groups, including a placebo group

Receiving Sioldosin 8 mg prior to intervention

Active Comparator group

Treatment:

Procedure: Preoperative sioldosin to facilitate ureteric access sheath insertion in RIRS

Receiving Placebo prior to intervention

Placebo Comparator group

Treatment:

Procedure: ureteric access sheath insertion in RIRS without silodosin (Placebo)