Double J Stenting and Sildosin After URSL for Lower Ureteric Stones

NCT ID: NCT05823662

Last Updated: 2023-04-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-03-02
• Study Completion Date: 2023-03-02

Brief Summary

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

Detailed Description

Ureteric calculi are known to affect approximately 10 - 15% of the overall population. The incidence of urolithiasis is rising over time. Most of these stones are known to pass spontaneously with or without expulsive medical therapy. The expulsion of calculus depends on the following factors: the calculus size and the location in the ureter (Alelign and Petros, 2018). The calculi expulsion rates change depending on these factors, with the expulsion rate ranging from 40% to 98% for calculi less than 5 mm. The calculi, which measure 6 mm or more have a spontaneous expulsion rate ranging between 35% to 50%.

Semirigid ureteroscopy (URS) lithotripsy has been shown to have high success rates for treating distal ureteric stones in many studies. However, URS is associated with some drawbacks, which may be risky and sometimes problematic.

The use of Double J (DJ) stent after ureteroscopy helps in the passage of residual fragments and prevents pain caused due to mucosal edema and obstruction. However, many patients complain of stent-related discomfort in the postoperative period. There is an additional need for stent removal, which is another surgical procedure adding to the cost of treatment. Despite its usefulness, the morbidity associated with these stents has been considered a potential health problem. However, many patients complain of stent-related discomfort in the postoperative period. There is an additional need for stent removal, which is another surgical procedure adding to the cost of treatment.

Silodosin is a highly selective alpha-1 adrenergic receptor antagonist which is used in the treatment of lower urinary tract symptoms (LUTS). Alpha-1 adrenergic receptors are densely found in the smooth muscle cells of the lower urinary tract, and silodosin relaxes them and improves the stent-related symptoms (SRS), and various studies have also shown similar effects. It has documented its use in the therapy of ureteric calculus.

Conditions

Lower Ureteric Stones; Ureteroscopic Lithotripsy; DJ Stenting

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

DJ stent group

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

Group Type: EXPERIMENTAL

DJ stent

Intervention Type: PROCEDURE

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

Silodosin group

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

Group Type: EXPERIMENTAL

Silodosin

Intervention Type: DRUG

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

Interventions

DJ stent

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

Intervention Type: PROCEDURE

Silodosin

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

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Benha University

OTHER

Sponsor Role: lead

Responsible Party

Ahmed Abou Elezz Abdel Fattah

Lecturer of Urology, Faculty of Medicine, Benha University, Benha, Egypt

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Benha University Hospitals

Banhā, , Egypt

Countries

Egypt

Other Identifiers

RC 6-2-2023

Identifier Type: -

Identifier Source: org_study_id