Oral Dissolution Therapy, Extracorporeal Shock Wave Lithotripsy, Noninvasive, Small, Medium, Radiolucent Renal Stones
Conditions
Brief summary
This study aimed to compare oral dissolution therapy (ODT), extracorporeal shock wave lithotripsy (ESWL), and a combination of ESWL and ODT as noninvasive modalities for treating small and medium-sized renal radiolucent.
Detailed description
Various methods exist for managing small and medium-sized radiolucent renal stones. These range from observation to oral dissolution therapy (ODT), percutaneous nephrolithotomy (PCNL), retrograde intrarenal surgery (RIRS), and extracorporeal shock wave lithotripsy (ESWL). Oral dissolving therapy diminishes the recurrence rates of stones. It positively influences the medical management of stone activity following ESWL in cases with residual calculi. By integrating oral dissolution therapy with extracorporeal shock wave lithotripsy, cases may experience the advantages of both non-invasive techniques. The combination of oral dissolution therapy and ESWL is an efficient therapeutic modality for radiolucent renal stones, dramatically reducing the overall stone volume. It also reduces the frequency of necessary extracorporeal shock wave lithotripsy sessions compared to treatment with ESWL alone
Interventions
DRUGOral dissolution therapy
Patients received guidance for oral potassium-sodium-hydrogen-citrate (6:6:3:5) at a dosage of twenty milliequivalents three times every day, along with a daily fluid intake of two to three liters and a food plan to restrict protein and sodium consumption for a maximum of three months.
Patients received extracorporeal shock wave lithotripsy utilizing a Dornier lithotripter equipped with an integrated ultrasound for stone localization. If the patient required additional sessions, up to a maximum of four sessions, at a rate of 60-90 shocks per minute, the period between sessions was three weeks.
PROCEDUREOral dissolution therapy + extracorporeal shock wave lithotripsy
Patients received a combination of oral dissolution therapy and extracorporeal shock wave lithotripsy.
Sponsors
Cairo University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age ≥ 18 years. * Both sexes. * Patients with a single radiolucent renal stone 0.5-2 cm at largest diameter diagnosed by non-contrast MSCT of the urinary tract (CTUT) ≤ 500 HU (Hounsfield Unit) and not seen on kidney, ureter, and bladder (KUB) X-ray.
Exclusion criteria
* Patients with Coagulation disorders, a pacemaker, severe deformity of the skeletal system, anatomical obstruction distal to the stone, and obesity (Body Mass Index more than or equal to 35 kilograms per meter square). * Patients with renal insufficiency (creatinine more than 1.7 mg/dl). * Patients with active urinary tract infections.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Stone-free status | 3 months after the procedure | To assess the stone-free status, which is characterized by no evidence of any residual stones in renal units by MSCT of the urinary tract (CTUT) at 3 months following oral dissolution therapy (ODT), extracorporeal shock wave lithotripsy (ESWL), or combined ODT and ESWL. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Complication rate | 3 months after the procedure | The complication rate of extracorporeal shock wave lithotripsy (ESWL) as hematuria, perinephric hematoma, renal colics, steinstrasse fragments, gastrointestinal tract upset, number of sessions needed, and the essential for auxiliary processes following 3 months as ureteroscopy (URS), Flexible URS, or percutaneous nephrolithotomy (PCNL). |
Countries
Egypt
Outcome results
None listed