Urology and Nephrology Center
Al Mansurah, DK, 35516, Egypt
NCT Number: NCT02373384
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.
Looking for future studies?
Notify Me18 year and older
All sexes
Interventional
Phase 4
Al Mansurah, DK, 35516, Egypt
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;
o Body mass index (BMI)
(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)
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
-
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.
Other names: systemic chemolysis
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.
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.
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.
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:
In the responders groups, factors predicting the success of treatment will be determined
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.
Mansoura University
Other
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT06615713
Calculi, Female Urogenital Diseases
Nadiād, India
View Trial DetailsNCT07101809
Calculi, Female Urogenital Diseases
Birmingham, Alabama, United States
View Trial DetailsNCT07155005
Calculi, Female Urogenital Diseases
View Trial DetailsNCT07172373
Calculi, Female Urogenital Diseases
View Trial Details