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

NCT ID: NCT02519153

Last Updated: 2017-07-05

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-07-31
• Study Completion Date: 2017-09-30

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.

Conditions

Ureteral Stone; Urolithiasis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

control

patient receive placebo for 4 weeks and followed for passage of stone distal ureter

Group Type: PLACEBO_COMPARATOR

Sildenafil

Intervention Type: DRUG

placebo will take nitrofuratoin once daily for 4 weeks . sildenafil arm will take sildenafil 50 mg once daily for 4 weeks

sildenafil

patient receive sildenafil 50 mg for 4 weeks once per day and followed for passage of stone distal ureter

Group Type: ACTIVE_COMPARATOR

Sildenafil

Intervention Type: DRUG

placebo will take nitrofuratoin once daily for 4 weeks . sildenafil arm will take sildenafil 50 mg once daily for 4 weeks

Interventions

Sildenafil

placebo will take nitrofuratoin once daily for 4 weeks . sildenafil arm will take sildenafil 50 mg once daily for 4 weeks

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Mansoura University

OTHER

Sponsor Role: lead

Responsible Party

mohamed awad tharwat

Urology & Nephrology Center

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

MThar87

Identifier Type: -

Identifier Source: org_study_id