Phosphodiesterase 5 Inhibitors (PDE5i) (Sildenafil) as Medical Expulsive Therapy in Distal Ureteral Stones

Phase 4

• Conditions: Urolithiasis; Ureteral Stone
• Interventions: Drug: Sildenafil

• Registration Number: NCT02519153
• Lead Sponsor: Mansoura University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-07
• Study First Submitted: 2015-06-30
• Study First Submitted QC: 2015-08-05
• Study First Posted: 2015-08-10
• Status Verified: 2017-07
• Last Update Submitted: 2017-07-02
• Last Update Posted: 2017-07-05
• Primary Completion: 2017-08
• Study Completion: 2017-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 100

Inclusion Criteria

1. Male Patient aged from 18-65 years.
2. Lower third ureteric stones at or below sacro-iliac joint .
3. Stone size rang from 5- 10 mm.
4. Unilateral ureteric stone

Exclusion Criteria

1. Patients who had recurrent fever.
2. Patient underwent ESWL.
3. Patient with rising serum creatinine > 2mg/dl.
4. Patient with history of uretero-vesical reimplantation.
5. Stone larger than 10 mm

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
control	Sildenafil	patient receive placebo for 4 weeks and followed for passage of stone distal ureter
sildenafil	Sildenafil	patient receive sildenafil 50 mg for 4 weeks once per day and followed for passage of stone distal ureter

Primary Outcome Measures

Name	Time	Method
the percentage of passage of lower ureteric stones.	one year

Secondary Outcome Measures

Name	Time	Method
number of patient need for analgesic treatment during their medical expulsive tharpy	one year