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

Urolithiasis Clinical Trial

Official title:

Role of Phosphodiesterase 5 Inhibitors (PDE5i) (Sildenafil) in Management of Distal Ureteral Stone

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02519153
• Other study ID #: MThar87
• Status: Active, not recruiting
• Phase: Phase 4
• First received: June 30, 2015
• Last updated: July 2, 2017
• Start date: July 2014
• Est. completion date: September 2017

Study information

• Verified date: July 2017
• Source: Mansoura University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 100
• Est. completion date: September 2017
• Est. primary completion date: August 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Ureteral Calculi
• Ureteral Stone
• Ureterolithiasis
• Urolithiasis

Intervention

Drug:
• Sildenafil
placebo will take nitrofuratoin once daily for 4 weeks . sildenafil arm will take sildenafil 50 mg once daily for 4 weeks

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Mansoura University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the percentage of passage of lower ureteric stones.		one year
Secondary	number of patient need for analgesic treatment during their medical expulsive tharpy		one year