Double J Stenting and Sildosin After URSL for Lower Ureteric Stones

NCT05823662 | Completed

• 1 other identifier: RC 6-2-2023
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this prospective comparative clinical study to compare DJ stenting and Sildosin after ureteroscopic lithotripsy for lower ureteric stones.

Conditions

Lower Ureteric Stones; Ureteroscopic Lithotripsy; DJ Stenting

Outcome Measures

Primary Outcomes (1)

• Stone-free rate

  Stone free rate 24 hours and stone free rate 73 hours Stone free rate 73 hours Stone free rate 24 hours Stone free rate 73 hours Stone free rate will be recorded

  3 weeks

Secondary Outcomes (2)

• Operative time

  Intraoperatively

• Comlications

  24 hours Postoperative

Study Arms (2)

DJ stent group

EXPERIMENTAL

A 5 Fr double J stent will be inserted and then removed after three weeks.

Procedure: DJ stent

Silodosin group

EXPERIMENTAL

Patients will be given one capsule of silodosin 8 mg at the night for three weeks.

Drug: Silodosin

Interventions

DJ stent PROCEDURE

A 5 Fr DJ stent will be inserted and then removed after three weeks.

DJ stent group

Silodosin DRUG

Patients will be given one capsule of silodosin 8 mg at the night for three weeks.

Silodosin group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Age \>18 to 60 years,
• Diagnosed with lower ureteric stone and those patients willing to participate and follow up in the study.

You may not qualify if:

• Patients having a previous or present history of prostatic or bladder surgery, malignancy, neurological disorder, pelvic irradiation, and diabetes.
• Acute or chronic renal insufficiency, solitary kidney or congenital urinary abnormality, cardiac disease, postoperative residual stone fragments, multiple or bilateral ureteral stones, patients with bilateral stents or long-term stenting with frequent change of stents, history of interstitial cystitis, chronic cystitis or prostatitis.
• Medical treatment (α blockers, beta-blockers, calcium antagonists, 5 alfa reductase inhibitors, phosphodiesterase type 5 inhibitors, anticholinergics and cholinergic, nitrates).
• Pregnant and lactating women and patients not available for follow-up will be excluded from this study.

Sponsors & Collaborators

• Benha University: lead

Study Sites (1)

Benha University Hospitals

Banhā, Egypt

Location

MeSH Terms

Interventions

silodosin

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 16, 2023
• First Posted: April 21, 2023
• Study Start: March 2, 2022
• Primary Completion: March 2, 2023
• Study Completion: March 2, 2023
• Last Updated: April 24, 2023

Record last verified: 2023-04

Data Sharing

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

Locations

EG (1)