Clinical trial NCT07018934: Alfuzosin and Mirabegron for Double-J Stent Symptoms
Official title: Comparison of the Efficacy of Alpha-Blockers and Mirabegron on Symptoms Associated With Double-J Stent Implanted After Retrograde Intrarenal Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ureteral Stent-Related Symptoms
Keywords: Nephrolithiasis
Ureteral Stent-Related Symptoms
Lower Urinary Tract Symptoms
Postoperative Pain
Retrograde Intrarenal Surgery
Lead sponsor: University of Gaziantep
Sponsor class: OTHER
First posted: 2025-06-13
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adult patients aged 18 to 75 years undergoing retrograde intrarenal surgery (RIRS) for renal stones, followed by double-J (DJ) stent placement

Brief summary: This prospective randomized controlled trial investigates the effects of alfuzosin, mirabegron, and their combination on stent-related symptoms and outcomes in patients undergoing DJ stent placement after retrograde intrarenal surgery (RIRS) for renal stones. The primary outcomes include stone-free rate and residual fragment status, while secondary outcomes focus on stent-related pain and lower urinary tract symptoms (LUTS). Patients will be randomly assigned to one of four groups: alfuzosin only, mirabegron only, combination therapy, or control. Pain and LUTS will be assessed using validated questionnaires such as the Ureteral Stent Symptom Questionnaire (USSQ) and IPSS.

Detailed description: Retrograde intrarenal surgery (RIRS) is a commonly used minimally invasive procedure for the treatment of renal stones. Postoperative placement of double-J (DJ) stents is often necessary but can result in significant stent-related discomfort and lower urinary tract symptoms (LUTS), which negatively impact patient quality of life. Alfuzosin, an alpha-blocker, and mirabegron, a beta-3 agonist, are pharmacological agents known to reduce stent-related symptoms. This study aims to compare the individual and combined efficacy of these agents on stent-related pain, LUTS, and postoperative stone outcomes. Patients will be evaluated for stone clearance, residual fragments (by imaging), and symptom scores over a follow-up period of 2 to 4 weeks post-RIRS

Eligibility criteria: Inclusion Criteria:

- Undergoing RIRS and DJ stenting

Ability to provide informed consent

Exclusion Criteria:

* Neurogenic bladder

Prostate volume \>40 mL or significant LUTS at baseline

Contraindications to alpha-blockers or mirabegron

Hepatic or severe renal impairment

Primary outcomes:
measure: Stent-Related Pain Score
timeFrame: Day 7 postoperatively and Day 14 postoperatively.
measure: Lower Urinary Tract Symptom (LUTS) Score
timeFrame: Day 7 postoperatively and Day 14 postoperatively
Secondary outcomes:
measure: Stone-Free Rate
timeFrame: Day 14 postoperatively
measure: Residual Fragment Status
timeFrame: Day 14 postoperatively
Other outcomes:
Locations:
city: Gaziantep
country: Turkey
facility: Gaziantep University Faculty of Medicine Hospital
Study officials:
References:
citation: Zhang K, Yan W, Li H, Chen J, Wang Q, Chai Y, Yuan L, Zhu G. Comparison of Mirabegron plus Tamsulosin and Tamsulosin Monotherapy for the Treatment of Ureteral Stent-Related Symptoms: A Prospective Randomized Study. Urol Int. 2022;106(12):1226-1232. doi: 10.1159/000526607. Epub 2022 Oct 14.
citation: Uslu M, Yildirim U, Ezer M, Erihan IB, Sarica K. Residual fragment size following retrograde intrarenal surgery: a critical evaluation of related variables. Urolithiasis. 2023 Aug 9;51(1):100. doi: 10.1007/s00240-023-01478-8.
citation: Geraghty RM, Davis NF, Tzelves L, Lombardo R, Yuan C, Thomas K, Petrik A, Neisius A, Turk C, Gambaro G, Skolarikos A, Somani BK. Best Practice in Interventional Management of Urolithiasis: An Update from the European Association of Urology Guidelines Panel for Urolithiasis 2022. Eur Urol Focus. 2023 Jan;9(1):199-208. doi: 10.1016/j.euf.2022.06.014. Epub 2022 Aug 1.
citation: Yuk HD, Park J, Cho SY, Sung LH, Jeong CW. The effect of preoperative ureteral stenting in retrograde Intrarenal surgery: a multicenter, propensity score-matched study. BMC Urol. 2020 Sep 14;20(1):147. doi: 10.1186/s12894-020-00715-1.