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Medical Expulsive Therapy Post-SWL For Renal Stones

M

Mansoura University

Status

Completed

Conditions

Stone, Kidney
Urolithiasis
Urologic Diseases

Treatments

Drug: Tamsulosin
Drug: Placebo

Study type

Interventional

Funder types

Other

Identifiers

NCT05032287
MET SWL

Details and patient eligibility

About

To evaluate the efficacy and stone free rate of placebo versus tamsulosin as medical expulsive therapy post-SWL in patients with renal stone less than 20 mm

Enrollment

235 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Renal stone ≤ 20 mm.
  • Lower calyceal stone ≤ 15 mm

Exclusion criteria

  • Women with known or suspected pregnancy or breastfeeding.
  • History of alpa-blockers (more than 7 days prior to study participation)
  • History of ureteral stricture
  • Multiple (that is more than 2) stones
  • Stone in solitary kidney (either anatomically or functionally).
  • Presence of urinary sepsis.
  • Estimated glomerular filtration rate < 30 ml/min
  • Contraindication or allergy to tamsulosin

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

235 participants in 2 patient groups, including a placebo group

tamsulosin
Active Comparator group
Description:
tamsulosin 0.4 mg once daily
Treatment:
Drug: Tamsulosin
Placeb
Placebo Comparator group
Description:
Placebo once daily
Treatment:
Drug: Placebo

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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