Back to resultsPhosphodiesterase 5 Inhibitors (PDE5i) (Sildenafil) as Medical Expulsive Therapy in Distal Ureteral Stones
Primary Purpose
Ureteral Stone, Urolithiasis
Status
Unknown status
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Sildenafil
Sponsored by
About this trial
This is an interventional treatment trial for Ureteral Stone focused on measuring Phosphodiesterase 5 Inhibitors, PDE5i, Sildinafil
Eligibility Criteria
Inclusion Criteria:
- Male Patient aged from 18-65 years.
- Lower third ureteric stones at or below sacro-iliac joint .
- Stone size rang from 5- 10 mm.
- Unilateral ureteric stone
Exclusion Criteria:
- Patients who had recurrent fever.
- Patient underwent ESWL.
- Patient with rising serum creatinine > 2mg/dl.
- Patient with history of uretero-vesical reimplantation.
- Stone larger than 10 mm
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Active Comparator
Arm Label
control
sildenafil
Arm Description
patient receive placebo for 4 weeks and followed for passage of stone distal ureter
patient receive sildenafil 50 mg for 4 weeks once per day and followed for passage of stone distal ureter
Outcomes
Primary Outcome Measures
the percentage of passage of lower ureteric stones.
Secondary Outcome Measures
number of patient need for analgesic treatment during their medical expulsive tharpy
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02519153
Brief Title
Phosphodiesterase 5 Inhibitors (PDE5i) (Sildenafil) as Medical Expulsive Therapy in Distal Ureteral Stones
Official Title
Role of Phosphodiesterase 5 Inhibitors (PDE5i) (Sildenafil) in Management of Distal Ureteral Stone
Study Type
Interventional
2. Study Status
Record Verification Date
July 2017
Overall Recruitment Status
Unknown status
Study Start Date
July 2014 (undefined)
Primary Completion Date
August 2017 (Anticipated)
Study Completion Date
September 2017 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mansoura University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Urolithiasis is one of the most common urological diseases. The risk of urolithiasis is estimated to be between 5% and 12% all over the world with increased incidence in male rather than female (2:1) respectively . Ureteral stones account for 20% from all urinary tract stones, more than 70% of the ureteral stones found in the lower third of the ureter . The incidence of urinary stones has been increasing day by day. Medical expulsive therapy (MET) of ureteral stones is the investigators' concern in this study. Stone location, size, number, ureteral spasm, mucosal edema or inflammation and ureteral anatomy are the factors affecting passage of the ureteral stones. So, MET is based on mechanism that stone passage is facilitated by the relaxation of ureteral smooth muscle , increasing hydrostatic pressure proximal to the stone and decreasing exciting edema . There are many oral medication could be used as MET such as adrenergic blockers, calcium channel blockers, prostaglandin synthesis inhibitors, glyceryl trinitrate and steroid treatment . Calcium-channel blockers and adrenergic α-antagonists are the main that has been proposed to enhance stone passage as expulsive medical therapy. Cyclic nucleotides are degraded by phosphodiesterases enzymes (PDEs). So using of PDE inhibtors may play role in relaxation of smooth muscle of the ureter. A study was done for evaluation of three PDE5 inhibtors, sildenafil , vardenafil and tadalafil, they found that PDE5 inhibitors can reverse the tension of isolated human ureteral smooth muscle via cGMP-mediated pathways.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ureteral Stone, Urolithiasis
Keywords
Phosphodiesterase 5 Inhibitors, PDE5i, Sildinafil
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
control
Arm Type
Placebo Comparator
Arm Description
patient receive placebo for 4 weeks and followed for passage of stone distal ureter
Arm Title
sildenafil
Arm Type
Active Comparator
Arm Description
patient receive sildenafil 50 mg for 4 weeks once per day and followed for passage of stone distal ureter
Intervention Type
Drug
Intervention Name(s)
Sildenafil
Intervention Description
placebo will take nitrofuratoin once daily for 4 weeks . sildenafil arm will take sildenafil 50 mg once daily for 4 weeks
Primary Outcome Measure Information:
Title
the percentage of passage of lower ureteric stones.
Time Frame
one year
Secondary Outcome Measure Information:
Title
number of patient need for analgesic treatment during their medical expulsive tharpy
Time Frame
one year
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Male Patient aged from 18-65 years.
Lower third ureteric stones at or below sacro-iliac joint .
Stone size rang from 5- 10 mm.
Unilateral ureteric stone
Exclusion Criteria:
Patients who had recurrent fever.
Patient underwent ESWL.
Patient with rising serum creatinine > 2mg/dl.
Patient with history of uretero-vesical reimplantation.
Stone larger than 10 mm
12. IPD Sharing Statement
Learn more about this trial
Phosphodiesterase 5 Inhibitors (PDE5i) (Sildenafil) as Medical Expulsive Therapy in Distal Ureteral Stones
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