This trial is active, not recruiting.

Conditions ureteral stone, urolithiasis
Treatment sildenafil
Phase phase 4
Sponsor Mansoura University
Start date July 2014
End date October 2015
Trial size 100 participants
Trial identifier NCT02519153, MThar87


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking single blind (subject)
Primary purpose treatment
(Placebo Comparator)
patient receive placebo for 4 weeks and followed for passage of stone distal ureter
placebo will take nitrofuratoin once daily for 4 weeks . sildenafil arm will take sildenafil 50 mg once daily for 4 weeks
(Active Comparator)
patient receive sildenafil 50 mg for 4 weeks once per day and followed for passage of stone distal ureter
placebo will take nitrofuratoin once daily for 4 weeks . sildenafil arm will take sildenafil 50 mg once daily for 4 weeks

Primary Outcomes

the percentage of passage of lower ureteric stones.
time frame: one year

Secondary Outcomes

number of patient need for analgesic treatment during their medical expulsive tharpy
time frame: one year

Eligibility Criteria

Male participants from 18 years up to 70 years old.

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

Additional Information

Official title Role of Phosphodiesterase 5 Inhibitors (PDE5i) (Sildenafil) in Management of Distal Ureteral Stone
Trial information was received from ClinicalTrials.gov and was last updated in October 2015.
Information provided to ClinicalTrials.gov by Mansoura University.