Study of Tamsulosin, Solifenacin and Mirabegron in Alleviating Ureteral Stent-related Symptoms
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Tamsulosin Hydrochloride 0.4 mg, Solifenacin Succinate 5 mg, Mirabegron 25 mg.
- Who it may be relevant to
- Registry conditions: Ureteral Stent-Related Symptom. Basic parameters: 18 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Nepal
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Comparative Study on the Efficacy of Tamsulosin, Solifenacin and Mirabegron in Alleviating Ureteral Stent-related Symptoms: a Randomized Controlled Trial
Overview
A comparative study on the efficacy of Tamsulosin, Solifenacin and Mirabegron in alleviating ureteral stent-related symptoms: a randomized controlled trial.
Detailed description
Ureteral stent related symptoms can be a major issue in patient undergoing stent placement after any procedure such as- complains of pain, urinary symptoms, sex related and work related and other symptoms. These symptoms can be alleviated with use of drugs such as Tamsulosin, Solifenacin and Mirabegron. Patient recruited in each arm of the study will have their stent related symptoms scoring done using a validated outcome assessment tool to measure the ureteral stent-related symptoms, Ureteral Stent Symptom Questionnaire (USSQ) on day 1, day 7 and day 14 after the stent placement.
Interventions
- Drug Tamsulosin Hydrochloride 0.4 mg
placement of ureteral stents followed by Cap. Tamsulosin 0.4 mg once daily - Drug Solifenacin Succinate 5 mg
placement of ureteral stents followed by Tab. Solifenacin 5 mg once daily - Drug Mirabegron 25 mg
placement of ureteral stents followed by Tab. Mirabegron 25 mg once daily
Primary outcome measures
- alleviating Ureteral stent related symptoms [Time frame: 2 weeks]
Secondary outcome measures (1)
- early removal of ureteral stent [Time frame: before 2 weeks]
Eligibility criteria
Inclusion criteria
- Eligible participants were adult patients (aged 19-80 years) who underwent unilateral retrograde rigid ureteroscopy (URS) or retrograde intrarenal surgery (RIRS) with planned ureteric stent insertion for urinary tract stones
Exclusion criteria
- Concomitant use of a-blockers, anticholinergics, corticosteroids, calcium channel blockers, and analgesics
- Undergoing percutaneous nephrolithotomy, open ureteric surgery or laparoscopic ureteric surgery, including ureterolithotomy
- Neurogenic bladder, Over Active Bladder (OAB) syndrome, and neurological and psychiatric diseases
- Preoperative febrile Urinary Tract Infection (UTI)
- Pregnancy or breastfeeding;
- A single kidney
- Moderate or severe cardiovascular or cerebrovascular disease
- Hepatic dysfunction
- History of pelvic surgery or irradiation
- History of bladder or prostate surgery
- Other acute medical conditions (including acute pancreatitis, acute gastroenteritis, musculoskeletal disorders) that might influence the Ureteral Stent Symptom Questionnaire(USSQ) pain score
- Allergy to any medication
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
Nepal · 1 center
- NAMS, Bir Hospital — Kathmandu
Identifiers
NCT: NCT06803030 · BirH