Silodosin in Facilitating Flexible Uretroscopy

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

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

42 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-02-01

Study Completion Date

2025-09-01

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Stone Ureter Stone, Kidney

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Receiving Sioldosin 8 mg prior to intervention

Group Type ACTIVE_COMPARATOR

Preoperative sioldosin to facilitate ureteric access sheath insertion in RIRS

Intervention Type PROCEDURE

group A (study group) that included 21 patients who received silodosin 'one capsule 8 mg per day for 1 week preoperatively

Receiving Placebo prior to intervention

Group Type PLACEBO_COMPARATOR

ureteric access sheath insertion in RIRS without silodosin (Placebo)

Intervention Type PROCEDURE

group B (study group) that included 21 patients who received Placebo'one capsule per day for 1 week preoperatively

Interventions

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Preoperative sioldosin to facilitate ureteric access sheath insertion in RIRS

group A (study group) that included 21 patients who received silodosin 'one capsule 8 mg per day for 1 week preoperatively

Intervention Type PROCEDURE

ureteric access sheath insertion in RIRS without silodosin (Placebo)

group B (study group) that included 21 patients who received Placebo'one capsule per day for 1 week preoperatively

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No