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The Predictors of Successful Oral Dissolution Therapy in Radiolucent Renal Stones; A Prospective Evaluation

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ClinicalTrials.gov Identifier: NCT02373384
Recruitment Status : Completed
First Posted : February 27, 2015
Last Update Posted : March 22, 2018
Sponsor:
Information provided by (Responsible Party):
Amr Abdel-Lateif El-Sawy, Mansoura University

Brief Summary:
The aim of the study is to evaluate the predictors of success of oral dissolution therapy in radiolucent renal stones in a large series of patients from a tertiary referral center in order to define the optimum case scenarios where oral dissolution therapy could be implemented.

Condition or disease Intervention/treatment Phase
Urolithiasis Renal Stones Drug: Oral alkalinization (Potassium citrate, Allopurinol) Behavioral: Life style modification Dietary Supplement: Dietary recommendations (decrease purine rich diet as red meat and fish, increase vegetables) Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 182 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Predictors of Successful Oral Dissolution Therapy in Radiolucent Renal Stones; A Prospective Evaluation
Study Start Date : February 2015
Actual Primary Completion Date : February 2017
Actual Study Completion Date : June 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Study group

Eligible patients, who fulfilled the study criteria, will be instructed For;

  1. Oral alkalinization

    • Potassium citrate 20 mEq three times daily
    • Hyperuricosuric patients (24-hours urine uric acid more than 750 mg/day in male and more than 650mg/day in females), will receive Allopurinol, a competitive inhibitor of xanthine oxidase, in a dose of 300 mg daily.
  2. Life style modification Adequate fluid intake in order to maintain urine volume between 2-3 L per day.
  3. Dietary recommendations

In hyperuricosuric patients (24-hours urine uric acid more than 750 mg/day in male and more than 650mg/day in females) ;

- Dietary modification will be advised in the form of decrease purine rich diet as red meat and fish, increase vegetables.

Drug: Oral alkalinization (Potassium citrate, Allopurinol)

Eligible patients, who fulfilled the study criteria, will be instructed For; Oral alkalinization therapy

  • Potassium citrate 20 mEq three times daily
  • Hyperuricosuric patients (24-hours urine uric acid more than 750 mg/day in male and more than 650mg/day in females) will receive:

Allopurinol, a competitive inhibitor of xanthine oxidase, in a dose of 300 mg daily.

Other Name: systemic chemolysis

Behavioral: Life style modification

Eligible patients, who fulfilled the study criteria, will be also instructed for;

Adequate fluid intake in order to maintain urine volume between 2-3 L per day.


Dietary Supplement: Dietary recommendations (decrease purine rich diet as red meat and fish, increase vegetables)
Eligible patients, who fulfilled the study criteria and they are hyperuricosuric (24-hours urine uric acid more than 750 mg/day in male and more than 650mg/day in females) will be also instructed for; Dietary modification will be advised in the form of decrease purine rich diet as red meat and fish, increase vegetables.




Primary Outcome Measures :
  1. The primary endpoint of this study will be change in stone surface area after 3 months of the determined protocol [ Time Frame: participants will be followed for the duration of medical treatment which is specified to be 3 months ]
    The stone surface area will be measured using the formula; Surface area = length X width X 0.25 X (22/7) Comparison of the stone surface area in relation to the initial surface area will be done.


Secondary Outcome Measures :
  1. Assessment of the predictors of response (more than 50% reduction in the surface area of the stone) to medical treatment [ Time Frame: participants will be followed for the duration of medical treatment which is specified to be 3 months ]

    The percent reduction of stone surface area will be calculated using the formula:

    Surface area = length X width X 0.25 X (22/7)

    Categorization of the patients into three groups will be done:

    • Patients who achieved 50% or more reduction in the stone surface area will be considered responsive and would be counseled for another 3 months therapy.
    • Patients with partial response, less than 50% reduction in stone surface area will be counseled for auxiliary procedure based on stone criteria e.g. ESWL.
    • Patients with no response/ serious renal infections or serious treatment adverse effects will be considered for other interventional treatment modalities.

    In the responders groups, factors predicting the success of treatment will be determined



Other Outcome Measures:
  1. The cost efficiency of this procedure [ Time Frame: participants will be followed for the duration of medical treatment which is specified to be 3 months ]
    Cumulative cost of medical treatment, including cost of medications and cost savings of sparred medical resources of interventional treatment will be assessed.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients' criteria:

    1. Ability to give informed consent.
    2. Age more than 18 years.
    3. Absence of significant hydronephrosis, serious urinary tract infection, congenital anomalies or distal ureteric obstruction in the affected renal unit.
    4. Normal cardiac, hematological, and renal functions.
  • Stone criteria:

    1. Primary or recurrent renal stone.
    2. Patients with residual renal stones after primary intervention whether open surgery, endoscopic or ESWL.
    3. Peripheral calyceal stones or stone in the renal pelvis with no significant hydronephrosis.
    4. Stone size less than 3 cm in maximum diameter
    5. Stones with radiodensity less than 600 Hounsefield units attenuation in Non Contrast Computed Tomography (NCCT).

Exclusion Criteria:

  • Patients' criteria:

    1. Inability to give informed consent.
    2. Age less than 18 years
    3. Patients with unremitting pain or serious urinary tract infection.
    4. Presence of significant hydronephrosis, congenital anomalies or distal ureteric obstruction in the affected renal unit.
    5. Abnormal cardiac, hematological or renal functions.
  • Stone criteria:

    1. Obstructing stone in the renal pelvis with significant hydronephrosis.
    2. Assumption of presence of calcium stones by presence of calcification in the stone in plain X-rays.

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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02373384


Locations
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Egypt
Urology and Nephrology Center
Mansoura, DK, Egypt, 35516
Sponsors and Collaborators
Mansoura University
Investigators
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Study Chair: Ahmed A. Shokeir, MD Urology And Nephrology Center, Mansoura University, Mansoura
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Responsible Party: Amr Abdel-Lateif El-Sawy, Resident in Urology, Urology and Nephrology Center, Mansoura University, Mansoura, Egypt, Mansoura University
ClinicalTrials.gov Identifier: NCT02373384    
Other Study ID Numbers: AEl-Sawy122015
First Posted: February 27, 2015    Key Record Dates
Last Update Posted: March 22, 2018
Last Verified: March 2018
Keywords provided by Amr Abdel-Lateif El-Sawy, Mansoura University:
Radiolucent renal stones
Oral dissolution therapy
Systemic chemolysis
Renal uric acid stones
Alkalinization
Additional relevant MeSH terms:
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Urolithiasis
Kidney Calculi
Nephrolithiasis
Calculi
Pathological Conditions, Anatomical
Urologic Diseases
Kidney Diseases
Urinary Calculi
Allopurinol
Potassium Citrate
Molecular Mechanisms of Pharmacological Action
Antimetabolites
Enzyme Inhibitors
Gout Suppressants
Antirheumatic Agents
Free Radical Scavengers
Antioxidants
Protective Agents
Physiological Effects of Drugs
Diuretics
Natriuretic Agents
Expectorants
Respiratory System Agents