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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.
Patients with renal stones, seen through the outpatient clinic in the urology department or post primary intervention for renal stones, will be assessed to see if the patient satisfies all inclusion and exclusion criteria. Patients who are meeting these criteria will be asked to participate in this prospective study. If they agree, they will be asked to sign an informed consent.
Baseline patients' assessment will include;
Full history taking including
Clinical examination including
o Body mass index (BMI)
Laboratory investigations including;
Initial radiological evaluation will include
(All NCCT studies will be performed with multislice helical CT scanners, NCCT images will be obtained from above the kidneys through the bladder base. For each renal stone, its location will be recorded, its size will be measured using the largest dimension from length (L), width (W) and height (H) on axial and coronal reformat images. Its mean density will be recorded by measurement using region of interest just smaller than the stone. Associated hydronephrosis proximal to the stone will be also evaluated (Nakada et al 2000).)
Patient will receive the allocated instructions and medications
Patients' follow up (The aim at follow up is to monitor the urinary PH with adjustment of the dose of potassium citrate and also to assess the compliance of the patients regarding the dietary recommendations and the medications)
After 2 weeks, 4 weeks, 8 weeks and 12 weeks.
- the most important parameter will be assessed is the urinary PH every two weeks. The target urinary PH should be kept between6.5 to 7.0, the dose of potassium citrate should be adjusted to achieve this value.
Patients' compliance to medications intake and the instruction of fluid intake and dietary modification.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Study group | Experimental | Eligible patients, who fulfilled the study criteria, will be instructed For;
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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oral alkalinization (Potassium citrate, Allopurinol) | Drug | Eligible patients, who fulfilled the study criteria, will be instructed For; Oral alkalinization therapy
Allopurinol, a competitive inhibitor of xanthine oxidase, in a dose of 300 mg daily. |
| Measure | Description | Time Frame |
|---|---|---|
| The primary endpoint of this study will be change in stone surface area after 3 months of the determined protocol | 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. | participants will be followed for the duration of medical treatment which is specified to be 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of the predictors of response (more than 50% reduction in the surface area of the stone) to medical treatment | 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:
In the responders groups, factors predicting the success of treatment will be determined |
| Measure | Description | Time Frame |
|---|---|---|
| The cost efficiency of this procedure | Cumulative cost of medical treatment, including cost of medications and cost savings of sparred medical resources of interventional treatment will be assessed. | participants will be followed for the duration of medical treatment which is specified to be 3 months |
Inclusion Criteria:
Patients' criteria:
Stone criteria:
Exclusion Criteria:
Patients' criteria:
Stone criteria:
Obstructing stone in the renal pelvis with significant hydronephrosis.
Assumption of presence of calcium stones by presence of calcification in the stone in plain X-rays.
-
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| Name | Affiliation | Role |
|---|---|---|
| Ahmed A. Shokeir, MD | Urology And Nephrology Center, Mansoura University, Mansoura | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Urology and Nephrology Center | Al Mansurah | DK | 35516 | Egypt |
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|
| Life style modification | Behavioral | 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 recommendations (decrease purine rich diet as red meat and fish, increase vegetables) | Dietary Supplement | 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. |
|
| participants will be followed for the duration of medical treatment which is specified to be 3 months |
| ID | Term |
|---|---|
| D052878 | Urolithiasis |
| D053040 | Nephrolithiasis |
| ID | Term |
|---|---|
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D007674 | Kidney Diseases |
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| ID | Term |
|---|---|
| D019357 | Potassium Citrate |
| D000493 | Allopurinol |
| D000069466 | Red Meat |
| D017404 | In Situ Hybridization, Fluorescence |
| ID | Term |
|---|---|
| D019343 | Citric Acid |
| D002951 | Citrates |
| D014233 | Tricarboxylic Acids |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D008460 | Meat |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |
| D017403 | In Situ Hybridization |
| D013194 | Staining and Labeling |
| D016591 | Histocytological Preparation Techniques |
| D003584 | Cytological Techniques |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D006652 | Histological Techniques |
| D008919 | Investigative Techniques |
| D020732 | Cytogenetic Analysis |
| D005821 | Genetic Techniques |
| D009693 | Nucleic Acid Hybridization |
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