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Double J Stenting and Sildosin After URSL for Lower Ureteric Stones (DJ)

Primary Purpose

Lower Ureteric Stones, Ureteroscopic Lithotripsy, DJ Stenting

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
DJ stent
Silodosin
Sponsored by
Benha University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lower Ureteric Stones

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Benha University Hospitals

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

DJ stent group

Silodosin group

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Operative time
Operative time in minutes will be recorded
Comlications
Complications as fever, flank pain, Lower Urinary lower urinary tract Symptoms or hematuria

Full Information

First Posted
March 16, 2023
Last Updated
April 20, 2023
Sponsor
Benha University
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1. Study Identification

Unique Protocol Identification Number
NCT05823662
Brief Title
Double J Stenting and Sildosin After URSL for Lower Ureteric Stones
Acronym
DJ
Official Title
Comparative Study Between DJ Stenting and Sildosin After Uretroscopic Lithotripsy for Lower Ureteric Stones
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
March 2, 2022 (Actual)
Primary Completion Date
March 2, 2023 (Actual)
Study Completion Date
March 2, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Benha University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lower Ureteric Stones, Ureteroscopic Lithotripsy, DJ Stenting

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
70 (Actual)

8. Arms, Groups, and Interventions

Arm Title
DJ stent group
Arm Type
Experimental
Arm Description
A 5 Fr double J stent will be inserted and then removed after three weeks.
Arm Title
Silodosin group
Arm Type
Experimental
Arm Description
Patients will be given one capsule of silodosin 8 mg at the night for three weeks.
Intervention Type
Procedure
Intervention Name(s)
DJ stent
Intervention Description
A 5 Fr DJ stent will be inserted and then removed after three weeks.
Intervention Type
Drug
Intervention Name(s)
Silodosin
Intervention Description
Patients will be given one capsule of silodosin 8 mg at the night for three weeks.
Primary Outcome Measure Information:
Title
Stone-free rate
Description
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
Time Frame
3 weeks
Secondary Outcome Measure Information:
Title
Operative time
Description
Operative time in minutes will be recorded
Time Frame
Intraoperatively
Title
Comlications
Description
Complications as fever, flank pain, Lower Urinary lower urinary tract Symptoms or hematuria
Time Frame
24 hours Postoperative

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Benha University Hospitals
City
Benha
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
The study will be available under a reasonable request from the corresponding author.
IPD Sharing Time Frame
One year after the end of the study

Learn more about this trial

Double J Stenting and Sildosin After URSL for Lower Ureteric Stones

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