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Active, Not Recruiting

NCT Number: NCT07068087

Silodosin in Facilitating Flexible Uretroscopy

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Stone Ureter Calculi Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Calculi Kidney Diseases Male Urogenital Diseases Nephrolithiasis Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Stone, Kidney Ureteral Diseases Ureterolithiasis Urinary Calculi Urogenital Diseases Urolithiasis Urologic Diseases

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ain Shams University hospitals (Demerdash)

Cairo, Abasia, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Preoperative sioldosin to facilitate ureteric access sheath insertion in RIRS

Procedure

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

ureteric access sheath insertion in RIRS without silodosin (Placebo)

Procedure

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

Primary outcomes

  1. Assess success of ureteric access sheath placement.

    Time frame: during the operation in the OR

    assess success of ureteric access sheath placement as follows: 1. spontaneous passage of UAS without dilatation or 2. passage of UAS after dilatation or 3. failure of the UAS insertion.

Secondary outcomes

  1. Operative time

    Time frame: from time of induction of anaesthesia in surgery till the end of procedure.

  2. Cost of the procedure

    Time frame: from admission and through study completion

    Overall cost of each procedure included cost of standard procedure of flexible URS added to cost of medication prior to operations. If any case needed ureteral dilatation, the cost of dilators was added. Also, in case of complications occurred, additional cost of management of these complications was added. Finally, in cases of failed UAS insertion, the cost of auxiliary procedure was added. Cost was calculated initially in Egyptian pounds and was converted to U.S dollars for standardization.

  3. complications

    Time frame: Perioperative and up to 24 weeks

    Assess postoperativePain, fever and Residual stones

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Official study title

Efficacy of Pre-operative Silodosin on Facilitating Insertion of Ureteral Access SheathPrior to Retrograde Intra Renal Surgery: A Randomized Controlled Study

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jul 16, 2025
Registry last updated
Jul 16, 2025

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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