Double J Stenting and Sildosin After URSL for Lower Ureteric Stones

Lower Ureteric Stones Clinical Trial

— DJ  

Official title:

Comparative Study Between DJ Stenting and Sildosin After Uretroscopic Lithotripsy for Lower Ureteric Stones

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05823662
• Other study ID #: RC 6-2-2023
• Status: Completed
• Phase: N/A
• Start date: March 2, 2022
• Est. completion date: March 2, 2023

Study information

• Verified date: April 2023
• Source: Benha University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: March 2, 2023
• Est. primary completion date: March 2, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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 (a 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.

Related Conditions & MeSH terms

• Lower Ureteric Stones
• Ureteral Calculi
• Ureterolithiasis

Intervention

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

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

Locations

Country	Name	City	State
Egypt	Benha University Hospitals	Benha

Sponsors (1)

Lead Sponsor	Collaborator
Benha University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Operative time	Operative time in minutes will be recorded	Intraoperatively
Secondary	Comlications	Complications as fever, flank pain, Lower Urinary lower urinary tract Symptoms or hematuria	24 hours Postoperative