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

Sponsor

Mansoura University (Other)

Overall Status

Unknown status

CT.gov ID

NCT02519153

Collaborator

(none)

100

Enrollment

Arms

Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Ureteral Stone Urolithiasis	Drug: Sildenafil	Phase 4

Study Design

Study Type:

Interventional

Anticipated Enrollment :

100 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Jul 1, 2014

Anticipated Primary Completion Date :

Aug 1, 2017

Anticipated Study Completion Date :

Sep 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: control patient receive placebo for 4 weeks and followed for passage of stone distal ureter	Drug: Sildenafil placebo will take nitrofuratoin once daily for 4 weeks . sildenafil arm will take sildenafil 50 mg once daily for 4 weeks
Active Comparator: sildenafil patient receive sildenafil 50 mg for 4 weeks once per day and followed for passage of stone distal ureter	Drug: Sildenafil placebo will take nitrofuratoin once daily for 4 weeks . sildenafil arm will take sildenafil 50 mg once daily for 4 weeks

Arm

Intervention/Treatment

Placebo Comparator: control

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

Drug: Sildenafil

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

Active Comparator: sildenafil

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

Drug: Sildenafil

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

Outcome Measures

Primary Outcome Measures

the percentage of passage of lower ureteric stones. [one year]

Secondary Outcome Measures

number of patient need for analgesic treatment during their medical expulsive tharpy [one year]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

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

Exclusion Criteria:

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Mansoura University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

mohamed awad tharwat, Urology & Nephrology Center, Mansoura University

ClinicalTrials.gov Identifier:

NCT02519153

Other Study ID Numbers:

MThar87

First Posted:

Aug 10, 2015

Last Update Posted:

Jul 5, 2017

Last Verified:

Jul 1, 2017

Keywords provided by mohamed awad tharwat, Urology & Nephrology Center, Mansoura University

Phosphodiesterase 5 Inhibitors

PDE5i

Sildinafil

Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 5, 2017