Health TrialsbyHealthPanel

Effect of Preoperative Silodosin on Feasibility of Ureteral Access Sheath Insertion

ConditionRenal Stone
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorAl-Azhar University

About this trial

The ureteral access sheath (UAS) is an ancillary device widely used by urologists to facilitate fast, repeatable, and safe access to ureters and collecting systems; improve visibility; reduce the risk of infection by reducing intrarenal pressure; and protect ureters and scopes when extracting multiple stones during surgery.

Insertion of ureteric access sheath may be difficult due to tight ureter, so sometimes preoperative stenting might be needed. Silodosin is an α1A adrenoceptor with high affinity and selectivity for the ureteric muscle, which may reduce ureteral spasm.

Oral a1-blockers can reduce intraureteral pressure, and may reduce maximal ureteral access sheath insertion force.¹ Preoperative silodosin protects against significant ureteral injury related to UAS insertion during fURS and decreases postoperative pain level. Silodosin premedication might be an effective and safe technique to replace prestenting.²

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

All patients with renal stones who will undergo flexible ureteroscopy and planned for using ureteral access sheath

Disqualifiers

Paediatric age group (less than 18 year)

Trial design

Design model

Parallel

Treatments tested in this trial

  • Ureteral access sheath placement during flexible ureteroscope for renal stones

    Procedure/Surgery

    Ureteral access sheath placement during flexible ureteroscope

Treatment groups

2,000 Participants
are divided into 2 treatment groups
Group A: Silodosin groupActive comparator 1 intervention
Group B: Non premedicated groupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

failure rate of UAS insertion during FURS

Time frame
2 hours

Secondary outcomes

1

Ureteral injuries after UAS insertion

Ureter wall injury will be classified according to the following five grades: Grade 0: No lesion or only mucosal petechiae. Grade 1: Mucosal erosion or a mucosal flap without smooth muscle injury. Grade 2: Erosion involving the mucosa and smooth muscle but sparing the adventitia. Grade 3: Ureteral perforation involving the full thickness of the ureteral wall, including the adventitia. Grade 4: Total ureteral avulsion with a complete rupture of ureteral continuity.

Time frame
3 hours
2

Post operative pain

a visual analog scale (VAS) score (0 = no pain to 10 = excruciating pain) to indicate the intensity of postoperative pain 12 h after surgery.

Time frame
12 hours after surgery
3

Complications related to the procedure

will be graded using the modified Clavien-Dindo classification system.

Time frame
3 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Al-Azhar University

Lead sponsor

Benha University

Collaborator

Alexandria University

Collaborator

Cairo University

Collaborator

Menoufia University

Collaborator

Tanta University

Collaborator

Source ClinicalTrials.gov
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