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Silodosin, Tadalafil Alone vs. Silodosin Plus Tadalafil as MET for Lower Ureteric Stones

Primary Purpose

Lower Ureteric Stones, Medical Expulsive Therapy, Tadalafil

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Placebo
Silodosin
Tadalafil
Silodosin and Tadalafil
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 - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 168 patients aged >18 years old. Both sexes. Diagnosed with lower ureteric stone from 5mm to 10mm in size. Exclusion Criteria: Patients with multiple or bilateral ureteric stones single kidney or impairment of renal function Urinary tract infection (UTI) Marked hydronephrosis Patients presenting with severe intractable pain and requiring emergency intervention Any urologic anomalies or history of ureteral surgery Pregnancy Pediatric populations Ischemic heart disease Congestive cardiac failure Complicated hypertension Patients on concomitant treatment with nitrates or calcium channel blockers.

Sites / Locations

  • Benha University Hospitals

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Placebo Comparator

Experimental

Experimental

Experimental

Arm Label

Placebo group

Silodosin group

Tadalafil group

Silodosin and Tadalafil

Arm Description

Patients in this group will receive placebo treatment once daily.

Patients will receive Silodosin 8 mg once daily.

Patients will receive Tadalafil 5 mg once daily.

Patients will receive Silodosin 8mg in combination with Tadalafil 5 mg once daily.

Outcomes

Primary Outcome Measures

Stone expulsion rate
Stone expulsion rate will be recorded

Secondary Outcome Measures

Stone expulsion time
Stone expulsion time will be recorded
Amount of analgesia used
The amount of analgesia used will be recorded

Full Information

First Posted
March 16, 2023
Last Updated
March 29, 2023
Sponsor
Benha University
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1. Study Identification

Unique Protocol Identification Number
NCT05789732
Brief Title
Silodosin, Tadalafil Alone vs. Silodosin Plus Tadalafil as MET for Lower Ureteric Stones
Official Title
Efficacy of Silodosin, Tadalafil Alone Versus Silodosin Plus Tadalafil as Medical Expulsive Therapy for Lower Ureteric Stones: A Prospective Randomized Placebo Controlled Study
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
March 30, 2022 (Actual)
Primary Completion Date
August 30, 2022 (Actual)
Study Completion Date
August 30, 2022 (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
This study will compare the efficacy of silodosin, tadalafil versus silodosin plus tadalafil as Medical Expulsive Therapy (MET) for lower ureteric stones.
Detailed Description
The global incidence of urolithiasis, a disease with a high recurrence rate, is increasing. Urolithiasis is one of the most common disorders of the urinary tract with a lifetime prevalence of up to 15% with men affected three times more than women. Urolithiasis causes recurrent stone formers to experience a decline in quality of life, and there is an increasing socioeconomic burden associated with the management of urolithiasis. Improved quality of life may also have increased its prevalence. A significant proportion, about 1/5th of urinary tract stones, is found in the ureter, of which 2/3rd is seen in the distal ureter. Initially, a colicky pain of various grades presents with ureteric stone. It is one of the most common problems that compel a patient to an emergency room. Methods to manage ureteral stones include conservative treatment, pharmacological treatment (e.g., medical expulsive therapy), shock wave lithotripsy, and surgical treatment. Thus, urologists must select the appropriate treatment for each patient (i.e., non-surgical or surgical). Today, medical expulsive therapy has become the most used modality of treatment for urolithiasis. During this treatment, the ureter smooth muscle is treated via various drugs by different mechanisms. Blocking alpha-(α-) 1 adrenergic receptor, especially in the distal third decreases basal smooth muscle contraction and causes propulsive antegrade peristalsis helping stone expulsion. By increasing the intraureteral pressure gradient around the stone, alpha-1 adrenergic receptor antagonists eject distal ureteral stones. Significant pathological changes can occur when ureteric stones are impacted. +is can cause an inflammatory reaction with mucosal edema which could further worsen the ureteric obstruction, increasing the risk of impaction and retention. However, selective alpha-1 blockers, such as tamsulosin and silodosin, have been the treatment of choice, with proven efficacy in multiple clinical trials. Silodosin is a more selective α-1A adrenoceptor blocker with a better stone expulsion rate than tamsulosin. Recently, a newer Phosphodiesterase type 5 inhibitor, tadalafil, has shown action on the nitric oxide-cyclic guanosine monophosphate signaling pathway of smooth muscles, resulting in increased levels of cyclic guanosine monophosphate, causing ureteric relaxation. Due to its smooth muscle relaxation mechanism, tadalafil has received US Food and Drug Administration approval to treat many urinary tract diseases. Therefore, the combination of silodosin and tadalafil drugs is aimed to facilitate stone passage by better ureteric relaxation and reducing intramural ureter pressure. Although there have been few similar studies using various combinations, comparing the efficacy of silodosin and tadalafil vs. silodosin are very few, and these studies have taken longer duration of treatment (4 to 6 weeks) which might have affected the outcome.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lower Ureteric Stones, Medical Expulsive Therapy, Tadalafil, Silodosin

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
168 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo group
Arm Type
Placebo Comparator
Arm Description
Patients in this group will receive placebo treatment once daily.
Arm Title
Silodosin group
Arm Type
Experimental
Arm Description
Patients will receive Silodosin 8 mg once daily.
Arm Title
Tadalafil group
Arm Type
Experimental
Arm Description
Patients will receive Tadalafil 5 mg once daily.
Arm Title
Silodosin and Tadalafil
Arm Type
Experimental
Arm Description
Patients will receive Silodosin 8mg in combination with Tadalafil 5 mg once daily.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Patients will receive placebo treatment once daily.
Intervention Type
Drug
Intervention Name(s)
Silodosin
Intervention Description
Patients will receive Silodosin 8 mg once daily.
Intervention Type
Drug
Intervention Name(s)
Tadalafil
Intervention Description
Patients will receive Tadalafil 5 mg once daily.
Intervention Type
Drug
Intervention Name(s)
Silodosin and Tadalafil
Intervention Description
Patients will receive Silodosin 8mg in combination with Tadalafil 5 mg once daily.
Primary Outcome Measure Information:
Title
Stone expulsion rate
Description
Stone expulsion rate will be recorded
Time Frame
Intraoperatively
Secondary Outcome Measure Information:
Title
Stone expulsion time
Description
Stone expulsion time will be recorded
Time Frame
Intraoperatively
Title
Amount of analgesia used
Description
The amount of analgesia used will be recorded
Time Frame
Intraoperatively

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 168 patients aged >18 years old. Both sexes. Diagnosed with lower ureteric stone from 5mm to 10mm in size. Exclusion Criteria: Patients with multiple or bilateral ureteric stones single kidney or impairment of renal function Urinary tract infection (UTI) Marked hydronephrosis Patients presenting with severe intractable pain and requiring emergency intervention Any urologic anomalies or history of ureteral surgery Pregnancy Pediatric populations Ischemic heart disease Congestive cardiac failure Complicated hypertension Patients on concomitant treatment with nitrates or calcium channel blockers.
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 of the corresponding author
IPD Sharing Time Frame
One year after the end of the study

Learn more about this trial

Silodosin, Tadalafil Alone vs. Silodosin Plus Tadalafil as MET for Lower Ureteric Stones

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