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

April 20, 2023 updated by: Ahmed Abou Elezz Abdel Fattah, Benha University

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

70

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Benha, Egypt
        • Benha University Hospitals

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: DJ stent group
A 5 Fr double J stent will be inserted and then removed after three weeks.
Procedure: DJ stent
A 5 Fr DJ stent will be inserted and then removed after three weeks.
Experimental: Silodosin group
Patients will be given one capsule of silodosin 8 mg at the night for three weeks.
Drug: Silodosin
Patients will be given one capsule of silodosin 8 mg at the night for three weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Stone-free rate
Time Frame: 3 weeks
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Operative time
Time Frame: Intraoperatively
Operative time in minutes will be recorded
Intraoperatively
Comlications
Time Frame: 24 hours Postoperative
Complications as fever, flank pain, Lower Urinary lower urinary tract Symptoms or hematuria
24 hours Postoperative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Benha University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 2, 2022

Primary Completion (Actual)

March 2, 2023

Study Completion (Actual)

March 2, 2023

Study Registration Dates

First Submitted

March 16, 2023

First Submitted That Met QC Criteria

April 10, 2023

First Posted (Actual)

April 21, 2023

Study Record Updates

Last Update Posted (Actual)

April 24, 2023

Last Update Submitted That Met QC Criteria

April 20, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RC 6-2-2023

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD 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

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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