Pre-Op Sildosine and Ureteral Dilation During F-URS

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

140 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-03-01

Study Completion Date

2023-03-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

We proposed that silodosin administration preoperatively may facilitate ureteral access sheath (UAS) placement prior to flexible ureteroscopy (F-URS) and decrease the incidence of ureteric injury in some difficult cases.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Silodosin in Facilitating Flexible Uretroscopy

NCT07068087

Stone Ureter Stone, Kidney

ACTIVE_NOT_RECRUITING NA

Effect of Preoperative Silodosin on Feasibility of Ureteral Access Sheath Insertion

NCT05833386

Renal Stone

RECRUITING NA

Silodosin in Retrograde Intrarenal Surgery

NCT05921370

Urolithiasis

COMPLETED PHASE3

Silodosin in Management of Lower Ureteral Stones

NCT06381206

Stone, Kidney

COMPLETED PHASE1/PHASE2

Optimal Drainage After Flexible Ureterorenoscopy; Prospective Assessment of Perioperative Outcomes and Health-Related Quality of Life Through a Randomized Controlled Trial

NCT04643145

Stones, Kidney

UNKNOWN NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Urolithiasis is a common urological disorder in the world and has a significant effect on the global health system. The goal of treatment is to achieve the highest stone-free rate (SFR) with the least invasive. Per¬cutaneous nephrolithotomy and flexible ureterorenoscopy (F-URS) are the two main minimally invasive procedures for the treatment of upper urinary tract stones.

The challenging step in flexible ureterorenoscopy (F-URS) is ureteroscopic access sheath (UAS) placement, which facilitates fast and safe access to the ureter and collecting system; improves visibility; reduces the risk of infection by reducing intrarenal pressure. However, in some cases, the acute ureteric injury may occur during ureteroscopic access sheath (UAS) placement.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

FURS Ureteral Dilatation Sildosine

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Sildosin group

included 70 patients for whom flexible ureteroscopy (F-URS) was done with the daily preoperative intake of 8 mg silodosin for one week.

Group Type EXPERIMENTAL

Sildosin group

Intervention Type DRUG

Patients in this group had flexible ureteroscopy (F-URS) with preoperative daily uptake of 8 mg silodosin for one week.

Placebo/control group

included 70 patients for whom flexible ureteroscopy (F-URS) was done with daily preoperative intake of placebo tablets.

Group Type EXPERIMENTAL

Placebo/control group

Intervention Type PROCEDURE

included 70 patients for whom flexible ureteroscopy (F-URS) was done with daily preoperative intake of placebo tablets.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Sildosin group

Patients in this group had flexible ureteroscopy (F-URS) with preoperative daily uptake of 8 mg silodosin for one week.

Intervention Type DRUG

Placebo/control group

included 70 patients for whom flexible ureteroscopy (F-URS) was done with daily preoperative intake of placebo tablets.

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Upper ureteric stone or stone kidney (with stone burden equal to or less than 20mm).
* 2\. Non stented.
* Age (Above 18 years old).

Exclusion Criteria

* Acute or chronic renal insufficiency.
* Uncorrected coagulopathy.
* Previous open (lumber or ureteric) surgery.
* Active urinary tract infection unless treated.

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No