ClinicalTrials.gg
RecruitingNCT06803030Updated Sep 8, 2025

Study of Tamsulosin, Solifenacin and Mirabegron in Alleviating Ureteral Stent-related Symptoms

A Phase 3 interventional study of Tamsulosin Hydrochloride 0.4 mg and Solifenacin Succinate 5 mg in Ureteral Stent-Related Symptom, sponsored by Bir Hospital. Recruiting at 1 site in Nepal. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2025-09-08.

Sponsored by Bir Hospital · Phase 3, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Dec 2025, 11 months ago, but the record still lists the study as recruiting.
  • Started Aug 2025; still recruiting 1 year 2 months later.
Phase
Phase 3
Study type
Interventional
Enrollment
189
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
01

Study summary

A comparative study on the efficacy of Tamsulosin, Solifenacin and Mirabegron in alleviating ureteral stent-related symptoms: a randomized controlled trial.

Read the 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.

02

Conditions studied

  • Ureteral Stent-Related Symptom

Keywords

  • Mirabegron
  • Tamsulosin
  • Solifenacin
03

In context

Lead sponsor

Bir Hospital is the lead sponsor of 3 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • Concomitant use of a-blockers, anticholinergics, , 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
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
189 participants (estimated)

Study arms

  • Active comparator
    Tamsulosin group

    placement of ureteral stents followed by Cap. Tamsulosin 0.4 mg once daily, to relieve the symptom

    Drug: Tamsulosin Hydrochloride 0.4 mg

  • Active comparator
    Solifenacin group

    placement of ureteral stents followed by Tab Solifenacin 5 mg once daily, to relieve the symptom

    Drug: Solifenacin Succinate 5 mg

  • Active comparator
    Mirabegron group

    placement of ureteral stents followed by Tab. Mirabegron 25 mg once daily, to relieve the symptom

    Drug: Mirabegron 25 mg

Interventions

  • placement of ureteral stents followed by Cap. Tamsulosin 0.4 mg once daily

    Also known as: Cap. Urimax 0.4 mg

  • placement of ureteral stents followed by Tab. Solifenacin 5 mg once daily

    Also known as: Tab. Solay 5 mg

  • placement of ureteral stents followed by Tab. Mirabegron 25 mg once daily

    Also known as: Tab. Mirasin 25 mg

06

What researchers measure

Primary outcomes

  1. alleviating Ureteral stent related symptoms

    mitigating the ureteric stent related symptoms using structured questionnaire

    Time frame: 2 weeks

Secondary outcomes

  1. early removal of ureteral stent

    early removal of stent due to stent migration, fever, urosepsis

    Time frame: before 2 weeks

07

Study locations

1 of 1 sites recruiting
  • NAMS, Bir Hospital
    Kathmandu, Bagmati 44600, Nepal
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Aug 2025 (actual). Primary completion is estimated for Dec 2025, 3 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 27, 2025
First posted
Jan 31, 2025
StartActual
Aug 30, 2025
Primary completionEst.
Dec 1, 2025
CompletionEst.
Dec 31, 2026
Last update
Sep 8, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 8, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06803030
Lead sponsor
Bir Hospital
Collaborators
Nepal Health Research Council
Responsible party
Jainendra Kumar Manoj (M Ch Urology Resident, Bir Hospital) — Principal investigator
First posted
Jan 31, 2025
Start date
Aug 30, 2025
Primary completion
Dec 1, 2025 (estimated)
Completion
Dec 31, 2026 (estimated)
Last update
Sep 8, 2025

Study contacts

Baikuntha Adhikari, MCh
Contact
baikadhe@gmail.com
+977 9849896780

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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Studies of the drugs tested here: Tamsulosin · Solifenacin · Mirabegron

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