Skip to content

The impact of silodosin on ureteric dilatation and operative outcomes in primary RIRS a Randomised control trail

The impact of silodosin on ureteric dilatation and operative outcomes in primary RIRS a Randomised control trail

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2026/04/108761
Enrollment
120
Registered
2026-04-20
Start date
Unknown
Completion date
Unknown
Last updated
2026-04-27

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

Conditions

Health Condition 1: N202- Calculus of kidney with calculus of ureter

Interventions

Intervention1: Silodosin group: Silodosin 8 mg oral capsule, administered once daily for 5 consecutive days prior to the scheduled retrograde intrarenal surgery (RIRS). Control Intervention1: Placebo

Sponsors

Dr Mathi Sri Akshay
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Patients with renal calculi less than2 cm planned for primary retrograde intrarenal surgery (RIRS) Normal renal function Patients able and willing to provide written informed consent ASA (American Society of Anesthesiologists) Grade I III

Exclusion criteria

Exclusion criteria: Pregnant or lactating women Patients with solitary kidney or anatomical abnormalities (PUJO, ureteric stricture, horseshoe kidney) Previous ureteric surgery or stenting on the side of surgery Known allergy or contraindication to alpha-blockers Patients already on alpha-blocker therapy for other indications Severe hepatic, renal, or cardiovascular disease (ASA grade IV) Active urinary tract infection or fever at presentation Patients unwilling or unable to comply with study protocol

Design outcomes

Primary

MeasureTime frame
Successful access sheath placement without the need for active ureteric dilatationTimepoint: Intraoperative, assessed at the time of ureteric access sheath placement during the RIRS procedure.

Secondary

MeasureTime frame
Incidence of ureteric injury Mean operative time Stone-free rate (no residual fragments less than two mm on CT KUB) Adverse drug reactions attributable to silodosin ( dizziness, postural hypotension, retrograde ejaculation)Timepoint: Operative time and ureteric injuries during surgery, intra operative. Stone free rate two weeks post surgery

Countries

India

Contacts

Public ContactDr Mathi Sri Akshay

Department of Urology, Government Mohan Kumaramangalam Medical College Hospital Salem

sriakshaymathi@gmail.com9640737722

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: May 1, 2026