ClinicalTrials.gg
CompletedNCT03388060Updated Aug 6, 2018

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

An interventional study of Ultrasound guided SWL and Dissolution therapy in Urologic Diseases, Stone, Urinary and Stone, Kidney, sponsored by Mansoura University. Completed at 1 site in Egypt. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-08-06.

Primary conditionKidney CalculiRegistry: Urologic DiseasesReclassifiedWhy we changed it
Registry
Urologic Diseases — the first condition term the registry derived for this study.
ClinicalTrials.gg
Kidney Calculi
Why
  1. The study's listed conditions name Kidney Calculi, a narrower term within Urologic Diseases.
Confidence
High: the new condition is named in the study's own listed conditions. Of 351 hand-checked studies reclassified this way, 68% were exactly right and 84% in the right disease family; the registry's first term was right for 5% (measured 2026-10-21). How we classify →
Wrong?
Tell us the study's main condition →

Sponsored by Mansoura University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 8 months after the study started (first participant enrolled Apr 2017, registered Dec 2017).
Phase
Not applicable
Study type
Interventional
Enrollment
150
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 12 studies in Kidney Calculi by Mansoura University — 1 open to participants now, 1 under way, none of them phase 3. Kidney Calculi · Mansoura University.

Enrollment
5th of 10
150 · median 140
Started
2017
the only one that year
No phase
9 of 12
1 open now
Registered
4th of 12
by date

Among the 12 studies in Kidney Calculi by Mansoura University, this one is the 5th largest by enrollment of the 10 interventional ones that give a count, is the only one that started in 2017, is one of 9 with no phase, and was the 4th registered.

Kidney Calculi

509 studies on the registry are indexed under Kidney Calculi; 146 are open to participants now.

This study's enrollment of 150 is above the median of 86 across 391 interventional studies indexed under Kidney Calculi.

Browse Kidney Calculi studies →

Open to participants now

1 of the 12 studies in Kidney Calculi by Mansoura University is open now, in 1 country. Each count lists the studies.

Where they have run

Who these studies take

Of the 88 Kidney Calculi studies recruiting now, 48 (55%) set no upper age limit and 23 (26%) stop at 75 or younger; 6 take children under 18; 11 take healthy volunteers.

This study: 18 Years and older · all sexes · no healthy volunteers.

The full table on the hub →
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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 12 studies in Kidney Calculi by Mansoura University, or all of them as a file.
02

Study 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 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.

03

Conditions studied

  • Urologic Diseases
  • Stone, Urinary
  • Stone, Kidney
  • ESWL
  • Radiolucent Calculus of Urinary Tract
  • Dissolution

Browse trials for

Keywords

  • Oral Dissolution Therapy
  • Kidney stone
  • ESWL
04

In context

Kidney Calculi Reclassified

509 studies on the registry are indexed under Kidney Calculi; 146 are open to participants now.

This study's enrollment of 150 is above the median of 86 across 391 interventional studies indexed under Kidney Calculi.

Browse Kidney Calculi studies →

Lead sponsor

Mansoura University is the lead sponsor of 1,119 studies on the registry; 183 are open to participants now.

Of its 9 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Compared within Kidney Calculi, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Urologic Diseases. The counts are of registry records indexed under each term, refreshed daily. How we classify →

05

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Pregnancy.
  • Bleeding diatheses.
  • Patients with a pacemaker.
  • Uncontrolled UTIs.
  • Severe skeletal malformations.
  • Severe obesity which prevent targeting of the stone; (40 or more).
  • Arterial aneurysm in the vicinity of the stone.
  • Anatomical obstruction distal to the stone.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

06

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
150 participants (actual)

Study arms

  • Active comparator
    Ultrasound guided SWL

    ultrasound guided SWL for Radiolucent stone

    Procedure: Ultrasound guided SWL

  • Active comparator
    Dissolution therapy

    Dissolution therapy for Radiolucent stone

    Procedure: Dissolution therapy

  • Active comparator
    Combined ultrasound guided SWL and dissolution therapy

    Combined treatment for Radiolucent stone.

    Procedure: Combined ultrasound guided SWL and dissolution therapy

Interventions

  • ProcedureUltrasound guided SWL

    Ultrasound guided SWL for radiolucent renal stone

  • ProcedureDissolution therapy

    Alkalinization dissolution therapy for radiolucent renal stone

  • ProcedureCombined ultrasound guided SWL and dissolution therapy

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

07

What researchers measure

Primary outcomes

  1. Stone free rate

    Free renal units from stones

    Time frame: 3 months

08

Study locations

1 site
  • Urology and Nephrology Center
    Mansourah, Aldakahlia 35516, Egypt
09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Apr 2017 to primary completion in Mar 2018, 11 months.

Of 183 non-industry interventional studies with no phase under Kidney Calculi, half reached primary completion within 31 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 54. This study's 11 months is below that.

Counting every sponsor, half of 199 studies reached it within 26 months; a quarter within 12 and three quarters within 51.

How these figures are worked out, and which studies are left out of them.

Registered
Dec 23, 2017
First posted
Jan 2, 2018
StartActual
Apr 1, 2017
Primary completionActual
Mar 30, 2018
CompletionActual
Mar 30, 2018
Last update
Aug 6, 2018
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 6, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03388060
Responsible party
Mohamed Abdelbaset (Principal investigator, Mansoura University) — Principal investigator
First posted
Jan 2, 2018
Start date
Apr 1, 2017
Primary completion
Mar 30, 2018
Completion
Mar 30, 2018
Last update
Aug 6, 2018

Study contacts

Khalid Sheir, MD
study chair · Shock wave unit chief - Urology and nephrology center

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2018. You cannot join it, but the record below documents what was studied.

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Discussion

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