Clinical trial NCT05921370: Silodosin in Retrograde Intrarenal Surgery
Official title: Effect of Perioperative Silodosin on Ureteric Dilatation in Retrograde Intrarenal Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Urolithiasis
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2023-06-27
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: ureteric access sheath placement
timeFrame: intraoperative immediate diagnosis, at the beginning of surgery.
Secondary outcomes:
measure: operative time
timeFrame: intraoperative diagnosis during the surgery from beginning of the surgery till the end of the procedure
measure: Perioperative complication
timeFrame: till 7 days postoperative
measure: Cost analysis
timeFrame: 1 day post operative
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ahmed Maher
state: القاهرة
Study officials:
References: