Efficacy of Pre-operative Silodosin on Facilitating Insertion of Ureteral Access SheathPrior to Retrograde Intra Renal Surgery: A Randomized Controlled Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Ain Shams University
- Enrollment
- 42
- Locations
- 1
- Primary Endpoint
- Assess success of ureteric access sheath placement.
Study Overview
Brief Summary
This study aims to provide robust evidence on whether a specific, potent pre-operative medication (silodosin) can make the critical step of ureteral access (UAS placement after dilation) easier and safer during f-URS for kidney stones in non-stented patients, potentially reducing complications and the need for pre-stenting.
Detailed Description
This study specifically evaluates the effect of administering pre-operative silodosin (8mg daily for one week) on facilitating ureteral dilation prior to ureteral access sheath (UAS) placement during flexible ureteroscopy (f-URS), aiming to leverage the drug's potent ureteral smooth muscle relaxation to ease mechanical dilation with Teflon dilators (6-14Fr) and subsequent UAS insertion. Its primary endpoint directly measures the ease of UAS placement (categorized as smooth, resistant, or failed) after sequential dilation. To objectively assess safety, post-operative diagnostic ureteroscopy by a second surgeon grades ureteral wall injuries using a specific 5-grade scale. Employing a rigorous randomized, placebo-controlled trial (RCT) design with strict criteria (non-stented patients, stone burden 1-2 cm, no prior interventions), the study also evaluates secondary outcomes including ureteral injury severity, stone-free rates (SFR), post-operative pain (VAS), complications, hospital stay length, and medication side effects.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to 60 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •adult male or female
- •single renal or ureteric stone
- •1 to 2 cm in size.
Exclusion Criteria
- •pregnant women
- •Untreated urinary tract infections
- •Uncorrected bleeding disorders or coagulopathies
- •Bilateral ureteric stones or multiple ipsilateral ureteric stones
- •ureteral stricture,
- •Patients who had previous ureteric stenting
Arms & Interventions
Receiving Placebo prior to intervention
Intervention: ureteric access sheath insertion in RIRS without silodosin (Placebo) (Procedure)
Receiving Sioldosin 8 mg prior to intervention
Intervention: Preoperative sioldosin to facilitate ureteric access sheath insertion in RIRS (Procedure)
Outcomes
Primary Outcomes
Assess success of ureteric access sheath placement.
Time Frame: during the operation in the OR
assess success of ureteric access sheath placement as follows: 1. spontaneous passage of UAS without dilatation or 2. passage of UAS after dilatation or 3. failure of the UAS insertion.
Secondary Outcomes
- Operative time(from time of induction of anaesthesia in surgery till the end of procedure.)
- Cost of the procedure(from admission and through study completion)
- complications(Perioperative and up to 24 weeks)
Investigators
Younan Ramsis
Lecturer of urology
Ain Shams University