Pre-Op Sildosine and Ureteral Dilation During F-URS

NCT05798572 | Completed

• 1 other identifier: Ms: 7-12-2022
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

FURS; Ureteral Dilatation; Sildosine

Outcome Measures

Primary Outcomes (1)

• Entrance to bladder time (ETBT)

  Entrance to bladder time (ETBT) will be recorded

  Intraoperatively

Secondary Outcomes (2)

• Entrance to ureteric orifice time (ETUOT)

  Intraoperatively

• Application of access sheath time (AAST)

  Intraoperatively

Study Arms (2)

Sildosin group

EXPERIMENTAL

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

Drug: Sildosin group

Placebo/control group

EXPERIMENTAL

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

Procedure: Placebo/control group

Interventions

Sildosin group DRUG

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

Sildosin group

Placebo/control group PROCEDURE

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

Placebo/control group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Benha University: lead

Study Sites (1)

Benha University Hospitals

Banhā, Benha, 13511, Egypt

Location

MeSH Terms

Interventions

Control Groups

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Urology, Faculty of Medicine, Benha University, Benha, Egypt

Study Record Dates

• First Submitted: March 23, 2023
• First Posted: April 4, 2023
• Study Start: March 1, 2022
• Primary Completion: March 1, 2023
• Study Completion: March 1, 2023
• Last Updated: July 11, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: One year after the end of the study.

Locations

EG (1)