Double-J stent-related lower urinary tract symptoms: a prospective randomized trial of mirabegron, solifenacin, tamsulosin, and tadalafil and their combinations

Efficacy of Mirabegron, Solifenacin, Tamsulosine, Tadalafil and Their Combinations in the Treatment of Double-J Stent-Related Lower Urinary Tract Symptoms

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

TCTR

Registry ID

TCTR20221014002

Enrollment

168

Registered

2022-10-14

Start date

2022-07-26

Completion date

Unknown

Last updated

2026-08-03

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

Conditions

Patients with Double-J Stent-Related Lower Urinary Tract Symptoms. Double-J Stent Lower Urinary Tract Symptoms Ureteral Stent Symptoms Questionnaire

Interventions

mirabegron 50 mg,solifenacin 5 mg ,tamsulosin 0,4 mg ,tadalafil 10 mg ,combination of mirabegron 25 mg + 5 mg solifenacin,combination of tamsulosine 0,4 mg + solifenacin 5 mg

Placebo Comparator Drug,Placebo Comparator Drug,Placebo Comparator Drug,Placebo Comparator Drug,Placebo Comparator Drug,Placebo Comparator Drug

Group A,Group B,Group C,Group D,Group E,Group F

Eligibility

Sex/Gender

All

Age

18 Years to 79 Years

Inclusion criteria

Inclusion criteria: Inclusion criterias are willing to undergo voluntary research, age 18 to 79 years old, has indications of endoscopic ureteral stent insertion, is diagnosed with ureteral stones less than 10 mm (with or without dilatation of pelvic, calix, ureter), ureteral stenosis, and or kidney stones and will undergo shockwave lithotripsy (ESWL), has had the first insertion of ureteral stent, and has indications for the unilateral ureteral stent insertion.

Exclusion criteria

Exclusion criteria: Exclusion criterias are history of malignancy in the urinary tract, history of hypertrophic prostate, history of previous sexual dysfunction, having had a urinary tract infections in the previous 6 months, pregnancy, history of diabetes mellitus, cardiovascular disease, or hypertension, having or undergoing radiation therapy, hormonal therapy, and or minor pelvic surgical procedures, previous surgery of ureteral reconstruction, history of alcoholism, history of stroke, having Alzheimers disease, having central nervous system trauma, having accompanying stones in the bladder, history of urethra diverticula in women, and hypersensitivity to Tadalafil or Tamsulosin or Mirabegron or Solifenacin.

Design outcomes

Primary

Measure	Time frame
treatment outcomes The Ureteral Stent Symptoms Questionnaire (USSQ) was used to compare treatment outcomes was measured 4 weeks after treatments. The Ureteral Stent Symptoms Questionnaire (USSQ)	—

Secondary

Measure	Time frame
demography data when the subject willing to undergo voluntary research age and gender	—

Countries

Indonesia

Contacts

Public ContactMuhammad Asykar Palinrungi

Hasanuddin University

apalinrungi@yahoo.com062411587571

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026