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

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ClinicalTrials.gov Identifier: NCT02519153
Recruitment Status : Active, not recruiting
First Posted : August 10, 2015
Last Update Posted : July 5, 2017
Sponsor:
Information provided by (Responsible Party):
mohamed awad tharwat, Mansoura University

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

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Study Type : Interventional  (Clinical Trial)
Estimated 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 : July 2014
Estimated Primary Completion Date : August 2017
Estimated Study Completion Date : September 2017

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. the percentage of passage of lower ureteric stones. [ Time Frame: one year ]

Secondary Outcome Measures :
  1. number of patient need for analgesic treatment during their medical expulsive tharpy [ Time Frame: one year ]


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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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

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Responsible Party: mohamed awad tharwat, Urology & Nephrology Center, Mansoura University
ClinicalTrials.gov Identifier: NCT02519153     History of Changes
Other Study ID Numbers: MThar87
First Posted: August 10, 2015    Key Record Dates
Last Update Posted: July 5, 2017
Last Verified: July 2017

Keywords provided by mohamed awad tharwat, Mansoura University:
Phosphodiesterase 5 Inhibitors
PDE5i
Sildinafil

Additional relevant MeSH terms:
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Urolithiasis
Ureteral Calculi
Ureterolithiasis
Urologic Diseases
Ureteral Diseases
Urinary Calculi
Calculi
Pathological Conditions, Anatomical
Sildenafil Citrate
Phosphodiesterase 5 Inhibitors
Vasodilator Agents
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Urological Agents