(SWL) Versus (ODT) Versus Combined SWL And ODT For Radiolucent Stone
Primary Purpose
Urologic Diseases, Stone, Urinary, Stone, Kidney
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Ultrasound guided SWL
Dissolution therapy
Combined ultrasound guided SWL and dissolution therapy
Sponsored by
About this trial
This is an interventional treatment trial for Urologic Diseases focused on measuring Oral Dissolution Therapy, Kidney stone, ESWL
Eligibility Criteria
Inclusion Criteria:
- Adult patient with 1-2.5 cm renal stones.
- Normal Serum creatinine
- Radiolucent stone by X-ray
Exclusion Criteria:
- Pregnancy.
- Bleeding diatheses.
- Patients with a pacemaker.
- Uncontrolled UTIs.
- Severe skeletal malformations.
- Severe obesity which prevent targeting of the stone; BMI (40 or more).
- Arterial aneurysm in the vicinity of the stone.
- Anatomical obstruction distal to the stone.
Sites / Locations
- Urology and Nephrology Center
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Active Comparator
Arm Label
Ultrasound guided SWL
Dissolution therapy
Combined ultrasound guided SWL and dissolution therapy
Arm Description
ultrasound guided SWL for Radiolucent stone
Dissolution therapy for Radiolucent stone
Combined treatment for Radiolucent stone.
Outcomes
Primary Outcome Measures
Stone free rate
Free renal units from stones
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03388060
Brief Title
(SWL) Versus (ODT) Versus Combined SWL And ODT For Radiolucent Stone
Official Title
Shockwave Lithotripsy (SWL) Versus Oral Dissolution Therapy (ODT) Versus Combined SWL And ODT For Radiolucent Renal Stone Randomised Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
April 1, 2017 (Actual)
Primary Completion Date
March 30, 2018 (Actual)
Study Completion Date
March 30, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mansoura University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
compare the efficacy of of ultrasound guided SWL versus dissolution therapy versus combined SWL and dissolution therapy in management of 1 - 2.5 cm renal stones.
Detailed Description
Urolithiasis is a common morbidity worldwide, affecting 10% to 15% of the population in Europe and North America. A higher prevalence of stone disease is found in hot or dry areas, including 20% to 25% in the Middle East. Radiolucent stones are mostly uric acid (UA) calculi, which varies geographically with worldwide incidence ranges from 5 to 40% and about 7- 10 percent of all calculi. Other rare radiolucent stones include xanthine and 2,8-dihydroxyadenine calculi.
The main etiologic factors for the development of uric acid nephrolithiasis are low urinary pH, hyperuricosuria, and low urinary volume. Practically, all of those who form uric acid stones have persistently low urinary pH, and most excrete normal amounts of uric acid. This suggests the potential importance of urinary pH manipulation in dissolving UA stones. Dissolution therapy for UA calculi is based on hydration and raising the urinary pH. European guidelines recommended that urine pH should be increased to a level above 6. The early published papers discussed the efficacy of oral chemo-dissolution therapy reporting high success rates. Since that era, there have been only a few publications, with widely variable results (15-80% complete dissolution rate).
Retrograde intrarenal surgery (RIRS), shockwave lithotripsy (SWL), and percutaneous nephrolithotomy (PCNL) are the three main non-medical modalities for treating medium-sized renal stones. Resorlu et al., retrospectively compare the outcomes of SWL, PNL, and RSIS for 10-20 mm radiolucent renal calculi of 437 patients and concluded that success rates "defined as stone-free status or asymptomatic insignificant residual fragments <3 mm." were 66.5, 91.4, and 87 % for SWL, PNL, and RIRS (p<0.001). in a prospective randomized of 135 patient with 1 to 2 cm radiolucent lower calyceal renal calculi, the 3-month stone-free rate of SWL, RIRS and miniperc was 73.8%, 86.1% and 95.1%, respectively (p =0.01).
Comparing the medical in the form of dissolution therapy versus non-medical in the form of SWL, Elderwy et al, in a prospective study on 87 children with radiolucent renal calculi with length less than 25 mm and a normal upper urinary tract or grade I HN, found that stone-free rate was 72.9% for dissolution therapy vs 82.1% after a single session of shock wave lithotripsy (p = 0.314).
Dissolution success is related to stone size as well as compliance. Larger stones demand longer therapy, and in these cases SWL may increase treatment efficacy by increasing stone surface area. So when Mokhless et al., use combined extracorporeal shock wave lithotripsy and dissolution therapy in radiolucent stone 12-65 mm in the largest diameter, stone-free rate of 100% was achieved in all 24 children after 3 months.9 To the best of our knowledge, there is no controlled trial comparing the efficacy of ultrasound guided SWL versus dissolution therapy versus combined SWL and dissolution therapy in management of 1 - 2.5 cm single renal stone.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urologic Diseases, Stone, Urinary, Stone, Kidney, ESWL, Radiolucent Calculus of Urinary Tract, Dissolution
Keywords
Oral Dissolution Therapy, Kidney stone, ESWL
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
150 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Ultrasound guided SWL
Arm Type
Active Comparator
Arm Description
ultrasound guided SWL for Radiolucent stone
Arm Title
Dissolution therapy
Arm Type
Active Comparator
Arm Description
Dissolution therapy for Radiolucent stone
Arm Title
Combined ultrasound guided SWL and dissolution therapy
Arm Type
Active Comparator
Arm Description
Combined treatment for Radiolucent stone.
Intervention Type
Procedure
Intervention Name(s)
Ultrasound guided SWL
Intervention Description
Ultrasound guided SWL for radiolucent renal stone
Intervention Type
Procedure
Intervention Name(s)
Dissolution therapy
Intervention Description
Alkalinization dissolution therapy for radiolucent renal stone
Intervention Type
Procedure
Intervention Name(s)
Combined ultrasound guided SWL and dissolution therapy
Intervention Description
Combined ultrasound guided SWL and alkalinization dissolution therapy for radiolucent renal stone
Primary Outcome Measure Information:
Title
Stone free rate
Description
Free renal units from stones
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Adult patient with 1-2.5 cm renal stones.
Normal Serum creatinine
Radiolucent stone by X-ray
Exclusion Criteria:
Pregnancy.
Bleeding diatheses.
Patients with a pacemaker.
Uncontrolled UTIs.
Severe skeletal malformations.
Severe obesity which prevent targeting of the stone; BMI (40 or more).
Arterial aneurysm in the vicinity of the stone.
Anatomical obstruction distal to the stone.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Khalid Sheir, MD
Organizational Affiliation
Shock wave unit chief - Urology and nephrology center
Official's Role
Study Chair
Facility Information:
Facility Name
Urology and Nephrology Center
City
Mansourah
State/Province
Aldakahlia
ZIP/Postal Code
35516
Country
Egypt
12. IPD Sharing Statement
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(SWL) Versus (ODT) Versus Combined SWL And ODT For Radiolucent Stone
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