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Effect of Tamsulosin vs Tadalafil on ureteric and renal stone clearance in patients receiving shock treatment

Effects of Tamsulosin vs Tadalafil on ureteric and renal stone clearance in patients receiving extracorporeal shock wave lithotripsy

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2018/01/011217
Enrollment
244
Registered
2018-01-10
Start date
Unknown
Completion date
Unknown
Last updated
2022-10-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- Ureteric and renal calculi Health Condition 2: N209- Urinary calculus, unspecified

Interventions

Intervention1: Tadalafil 5mg once daily until stone clearance or for a maximum of 30 days.: Phosphodiesterase inhibitor drug use in renal and ureteric stone expulsion along with shock wave lithotripsy

Sponsors

Christian Medical College and Hospital Vellore
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: a.Patients planned for SWL b.Single radiopaque renal 6 to 24 mm or c.Single ureteral 6 to 15 mm calculus

Exclusion criteria

Exclusion criteria: a.Radiolucent calculus b.Past unsuccessful SWL c.Renal impairment (creatinine greater than 1.5 mg/dl) d.Radiolucent calculus e. Urinary tract infection f. On calcium channel blockers, nitrates, alpha1-adrenergic antagonists or PDE5 inhibitors g. Congenital urinary tract anomalies h. Contraindication to PDE5 inhibitors or alpha blockers i. Children

Design outcomes

Primary

MeasureTime frame
Successful stone clearanceTimepoint: Stone-free status or presence of clinically insignificant asymptomatic residual fragments remaining in the kidney of less than 3 mm at 1 month or earlier.

Secondary

MeasureTime frame
Expulsion timeTimepoint: Duration in days - From day of start of study to stone clearance;Side effects of tamsulosin and tadafilTimepoint: Tamsulosin - dizziness, drowsiness, weakness; nausea, dyspepsia, diarrhea; headache, chest pain; abnormal ejaculation, back pain; blurred vision; tooth problems; fever, chills, body aches, flu symptoms. Tadalafil - redness or warmth in face, neck, or chest; Flu symptoms, headache; memory problems; diarrhea, dyspepsia or muscular pain, back pain.;SteinstrasseTimepoint: Incidence of Steinstrasse and its eventual clearance;Analgesic requirementTimepoint: Amount of analgesic ingested for pain episodes, pain episodes requiring hospital visit

Countries

India

Contacts

Public ContactDr Madhuri Sadanala

Christian Medical College and Hospital, Vellore

drsksingh@hotmail.com04162282111

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026