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Urologic DiseasesNCT03388060

(SWL) Versus (ODT) Versus Combined SWL And ODT For Radiolucent Stone

A study testing Ultrasound guided SWL, Dissolution therapy and Combined ultrasound guided SWL and dissolution therapy in people with Urologic Diseases and Stone, Urinary, run by Mansoura University at 1 site in Egypt.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Urologic Diseases, Stone, Urinary, Stone, Kidney
What is being tested?
Ultrasound guided SWL, Dissolution therapy and Combined ultrasound guided SWL and dissolution therapy
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
150 participants
Where
1 siteEgypt
Study dates
1 Apr 2017to 30 Mar 2018
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Adult patient with 1-2.5 cm renal stones.
  • Normal Serum creatinine
  • Radiolucent stone by X-ray

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Egypt1 site
  • Urology and Nephrology Center

    Al Mansurah, Aldakahlia, 35516

Other trials in Egypt

About this study

Official title: Shockwave Lithotripsy (SWL) Versus Oral Dissolution Therapy (ODT) Versus Combined SWL And ODT For Radiolucent Renal Stone Randomised Controlled Trial

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.

Read the 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.

Being tested
Ultrasound guided SWL, Dissolution therapy, Combined ultrasound guided SWL and dissolution therapy
Keywords
Oral Dissolution Therapy, Kidney stone, ESWL
Medical subject headings
Urologic Diseases, Urinary Calculi, Kidney Calculi

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Ultrasound guided SWLProcedure or surgery

    Ultrasound guided SWL for radiolucent renal stone

  • Dissolution therapyProcedure or surgery

    Alkalinization dissolution therapy for radiolucent renal stone

  • Combined ultrasound guided SWL and dissolution therapyProcedure or surgery

    Combined ultrasound guided SWL and alkalinization dissolution therapy for radiolucent renal stone

Study groups in NCT03388060
Study groupRoleWhat they receive
Ultrasound guided SWLActive comparatorultrasound guided SWL for Radiolucent stone
Receives: Procedure: Ultrasound guided SWL
Dissolution therapyActive comparatorDissolution therapy for Radiolucent stone
Receives: Procedure: Dissolution therapy
Combined ultrasound guided SWL and dissolution therapyActive comparatorCombined treatment for Radiolucent stone.
Receives: Procedure: Combined ultrasound guided SWL and dissolution therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Stone free rate

    Free renal units from stones

    Measured: 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Jan 2018
  2. Study start1 Apr 2017
  3. Primary completion30 Mar 2018
  4. Study completion30 Mar 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
150 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03388060
Sponsor's protocol ID
RL STONE
Status last verified
Aug 2018
First submitted
23 Dec 2017
Last updated
6 Aug 2018
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Ultrasound guided SWL, Dissolution therapy and Combined ultrasound guided SWL and dissolution therapy in people with Urologic Diseases and Stone, Urinary, run by Mansoura University at 1 site in Egypt.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Stone free rate (time frame: 3 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2018.

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