Silodosin in Retrograde Intrarenal Surgery

NCT ID: NCT05921370

Last Updated: 2024-07-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-04-04
• Study Completion Date: 2023-09-01

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.

Detailed Description

The ureteral access sheaths (UAS) used during Retrograde Intrarenal Surgery (RIRS) were produced for easy access to the upper urinary tract. The main advantages of UAS are providing repetitive access to the ureteral and collecting duct system, decreasing intrarenal pressure, preventing bleeding-related distortion of vision by the acceleration of liquid flow, and eventually contributing toward the protection of the flexible device.

Nevertheless, there might be certain challenges during UAS placement. There are also risks, such as ureteral injury and the occurrence of ureteral stricture in the long term. However, considering the benefit/risk balance, RIRS is routinely performed in many clinics because of the ease provided by UAS.

Some problems might occur during the placement of UAS whose diameters vary between 9.5 and 14 Fr. In cases where UAS cannot be placed, manipulations can be used, such as ureteral balloon dilatation, providing access through a rigid ureteroscope with a guide wire, or dilatation with the inner sheath of the UAS, which may vary depending on the amount of personal experience. Despite such manipulations, if UAS placement is still unsuccessful, it is always more logical to place a double-J stent, enables passive dilatation, and postpone RIRS until the second operation.

This study will examine whether intramural ureteral resistance can be reduced or not and whether UAS placement can be facilitated using silodosin or not.

Conditions

Urolithiasis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Silodosin group (the intervention group)

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

Group Type: EXPERIMENTAL

Silodosin 8 mg

Intervention Type: 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

Placebo group (the control group)

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: 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.

Interventions

Silodosin 8 mg

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

Intervention Type: DRUG

Placebo

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.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• • < 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ain Shams University

OTHER

Sponsor Role: lead

Responsible Party

Ahmed Maher Gamil Ahmed Higazy

principle investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Ahmed Maher

Cairo, Cairo Governorate, Egypt

Countries

Egypt

Other Identifiers

MS 231/2023

Identifier Type: -

Identifier Source: org_study_id