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

NCT02519153 | Unknown Phase 4 DMC

• 1 other identifier: MThar87
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

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

Keywords

Phosphodiesterase 5 Inhibitors; PDE5i; Sildinafil

Outcome Measures

Primary Outcomes (1)

• the percentage of passage of lower ureteric stones.

  one year

Secondary Outcomes (1)

• number of patient need for analgesic treatment during their medical expulsive tharpy

  one year

Study Arms (2)

control

PLACEBO COMPARATOR

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

Drug: Sildenafil

sildenafil

ACTIVE COMPARATOR

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

Drug: Sildenafil

Interventions

Sildenafil DRUG

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

control; sildenafil

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mansoura University: lead

MeSH Terms

Conditions

Ureterolithiasis; Urolithiasis

Interventions

Sildenafil Citrate

Condition Hierarchy (Ancestors)

Ureteral Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Sulfonamides; Amides; Organic Chemicals; Sulfones; Sulfur Compounds; Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Urology & Nephrology Center

Study Record Dates

• First Submitted: June 30, 2015
• First Posted: August 10, 2015
• Study Start: July 1, 2014
• Primary Completion: August 1, 2017
• Study Completion: September 1, 2017
• Last Updated: July 5, 2017

Record last verified: 2017-07