NCT02373384

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 182 (actual)
• Sponsor: Mansoura University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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 * Previous stone history regarding presentation and management * Previous trial oral dissolution therapy for renal stones and their compliance to the treatment * Previous GIT surgery * History of chronic medical or metabolic illness e.g; DM * Clinical examination including o Body mass index (BMI) * Laboratory investigations including; * Urine analysis (urine PH) * 24 hours urine testing for uric acid and citrate * Urine culture * Serum creatinine * Random blood sugar (RBS) * Serum uric acid * Serum calcium, phosphorus and magnesium. * Initial radiological evaluation will include * Renal ultrasonography (US) * Plain X-rays to exclude the presence of calcification in the targeted stone. * Non Contrast Computed Tomography (NCCT) on the abdomen and pelvis. * MAG3 diuretic renogram (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.

Conditions

• Urolithiasis
• Renal Stones

Interventions

Type	Name	Description
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.
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.

Timeline

• Start date: 2015-02-01
• Primary completion: 2017-02-01
• Completion: 2017-06-01
• First posted: 2015-02-27
• Last updated: 2018-03-22

Locations

1 site across 1 country: Egypt