Silodosin in Retrograde Intrarenal Surgery

NCT05921370 | Completed Phase 3

• 1 other identifier: MS 231/2023
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Selective alpha-blockers have been used for the treatment of ureteric stones as medical expulsive therapy (MET). Recently they have been successfully used in passive ureteric dilatation before semirigid ureteroscopy. This study enables us to know the role of silodosin in ureteric dilatation to facilitate ureteral access sheath placement in Retrograde Intrarenal Surgery with flexible ureteroscopy.

Conditions

Urolithiasis

Outcome Measures

Primary Outcomes (1)

• ureteric access sheath placement

  to assess the success of ureteric access sheath placement as follows: 1\. Direct assessment: A. Success of ureteric access sheath insertion without ureteric dilatation. B. Success of ureteric access sheath insertion with ureteric dilatation. C. Failed ureteric access sheath insertion.

  intraoperative immediate diagnosis, at the beginning of surgery.

Secondary Outcomes (3)

• operative time

  intraoperative diagnosis during the surgery from beginning of the surgery till the end of the procedure

• Perioperative complication

  till 7 days postoperative

• Cost analysis

  1 day post operative

Study Arms (2)

Silodosin group (the intervention group)

EXPERIMENTAL

Patients will receive silodosin 8 mg one tablet per day for 7 days before their scheduled retrograde intrarenal surgery.

Drug: Silodosin 8 mg

Placebo group (the control group)

PLACEBO COMPARATOR

Patients will receive Placebo for 7 days before their scheduled retrograde intrarenal surgery.

Drug: Placebo

Interventions

Silodosin 8 mg DRUG

This prospective study will be conducted on patients prepared for Retrograde intrarenal surgery presented to Ain Shams University Hospital. Patients will be randomized with 1:1 ratio into 2 equal groups. Group A (the study group): Patients will receive silodosin 8 mg one tablet per day for 7 days before their scheduled retrograde intrarenal surgery. silodosin is an alpha blocker which act to dilate the ureter to facilitate access sheath placement

Silodosin group (the intervention group)

Placebo DRUG

This prospective study will be conducted on patients prepared for Retrograde intrarenal surgery presented to Ain Shams University Hospital. Patients will be randomized with 1:1 ratio into 2 equal groups. Group A (the study group): Patients will receive silodosin 8 mg one tablet per day for 7 days before their scheduled retrograde intrarenal surgery. Group B (the control group): Patients will receive Placebo for 7 days before their scheduled retrograde intrarenal surgery.

Placebo group (the control group)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Both sex.
• Age \>18 yrs old.
• Upper ureteric stones or renal stones \< 2 cm.
• Patients with normal renal anatomy.
• No history of infectious or inflammatory renal condition.

You may not qualify if:

• \< 18 years old.
• Multiple or bilateral stones.
• Pregnant women.
• Ureteric strictures.
• Urinary tract infection.
• Coagulopathy and uncorrected bleeding disorders.
• Refusal of the surgery and requiring stent.

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ahmed Maher

Cairo, Cairo Governorate, 11757, Egypt

Location

MeSH Terms

Conditions

Urolithiasis

Interventions

silodosin

Condition Hierarchy (Ancestors)

Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principle investigator

Model Details: This prospective study will be conducted in patients prepared for RIRS presented to Ain Shams University Hospital. Group A (the study group): Patients will receive silodosin 8 mg one tablet per day for 7 days Group B (the control group): Patients will receive Placebo for 7 days before their scheduled retrograde intrarenal surgery.

Study Record Dates

• First Submitted: June 18, 2023
• First Posted: June 27, 2023
• Study Start: April 4, 2023
• Primary Completion: July 1, 2023
• Study Completion: September 1, 2023
• Last Updated: July 16, 2024

Record last verified: 2024-07

Locations

EG (1)