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

NCT02373384 | Completed Phase 4 DMC

• 1 other identifier: AEl-Sawy122015
• Study Type: interventional
• Target: 182
• Locations: 1 country
• Sites: 1

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.

Conditions

Urolithiasis; Renal Stones

Keywords

Radiolucent renal stones; Oral dissolution therapy; Systemic chemolysis; Renal uric acid stones; Alkalinization

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Assessment of the predictors of response (more than 50% reduction in the surface area of the stone) to medical treatment

  participants will be followed for the duration of medical treatment which is specified to be 3 months

Other Outcomes (1)

• The cost efficiency of this procedure

  participants will be followed for the duration of medical treatment which is specified to be 3 months

Study Arms (1)

Study group

EXPERIMENTAL

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); Behavioral: Life style modification; Dietary Supplement: Dietary recommendations (decrease purine rich diet as red meat and fish, increase vegetables)

Interventions

Oral alkalinization (Potassium citrate, Allopurinol) DRUG

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.

Also known as: systemic chemolysis

Study group

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.

Study group

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.

Study group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients' criteria:
• Ability to give informed consent.
• Age more than 18 years.
• Absence of significant hydronephrosis, serious urinary tract infection, congenital anomalies or distal ureteric obstruction in the affected renal unit.
• Normal cardiac, hematological, and renal functions.
• Stone criteria:
• Primary or recurrent renal stone.
• Patients with residual renal stones after primary intervention whether open surgery, endoscopic or ESWL.
• Peripheral calyceal stones or stone in the renal pelvis with no significant hydronephrosis.
• Stone size less than 3 cm in maximum diameter
• Stones with radiodensity less than 600 Hounsefield units attenuation in Non Contrast Computed Tomography (NCCT).

You may not qualify if:

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

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (1)

Urology and Nephrology Center

Al Mansurah, DK, 35516, Egypt

Location

MeSH Terms

Conditions

Urolithiasis; Nephrolithiasis

Interventions

Potassium Citrate; Allopurinol; Red Meat; In Situ Hybridization, Fluorescence

Condition Hierarchy (Ancestors)

Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Kidney Diseases

Intervention Hierarchy (Ancestors)

Citric Acid; Citrates; Tricarboxylic Acids; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Meat; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages; In Situ Hybridization; Staining and Labeling; Histocytological Preparation Techniques; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Histological Techniques; Investigative Techniques; Cytogenetic Analysis; Genetic Techniques; Nucleic Acid Hybridization

Study Officials

• Ahmed A. Shokeir, MD

  Urology And Nephrology Center, Mansoura University, Mansoura

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident in Urology, Urology and Nephrology Center, Mansoura University, Mansoura, Egypt

Study Record Dates

• First Submitted: February 13, 2015
• First Posted: February 27, 2015
• Study Start: February 1, 2015
• Primary Completion: February 1, 2017
• Study Completion: June 1, 2017
• Last Updated: March 22, 2018

Record last verified: 2018-03

Locations

EG (1)