Ureteral Stent-Related SymptomPhase 4NCT07114848
Comparing Tamsulosin and Solifenacin for Relieving Double J Stent Symptoms: Using the USSQ.
A Phase 4 study testing Tamsulosin and solifenacin in people with Ureteral Stent-Related Symptom and Alpha Blocker, run by Liaquat National Hospital & Medical College at 1 site in Pakistan.
Trial summary
This study evaluates the effects of two medications-tamsulosin and solifenacin-on symptoms associated with double J (DJ) ureteral stents. The research is conducted among patients undergoing unilateral DJ stent placement for ureteric calculi or post-ureteroscopic lithotripsy. Read more about this study
- Who is it for?
- Ages 20 to 50 years
- Conditions the study is for
- Ureteral Stent-Related Symptom, Alpha Blocker, Anticholinergics
- What is being tested?
- Tamsulosin and solifenacin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 sitePakistan
- Study dates
- 13 Jun 2024to 30 Mar 2025
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age 20 to 50 years
- Undergoing unilateral DJ stenting for:
- Ureteric calculi
- Post-ureteroscopic lithotripsy
Who cannot join
- Bilateral stents
- History of LUTS or recurrent UTI
- Urological malignancy or bladder surgery
- Known hypersensitivity to alpha-blockers or anticholinergics
- Uncontrolled hypertension, cardiovascular instability
- Chronic liver or kidney disease
- Stent complications (migration, encrustation, infection)
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Liaquat National Hospital, Karachi, Pakistan
Karachi, Sindh, 75330
About this study
Official title: Comparative Efficacy of Tamsulosin and Solifenacin in Managing Double J Stent-Related Symptoms: A Randomized Clinical Study Using the USSQ Tool.
This study evaluates the effects of two medications-tamsulosin and solifenacin-on symptoms associated with double J (DJ) ureteral stents. The research is conducted among patients undergoing unilateral DJ stent placement for ureteric calculi or post-ureteroscopic lithotripsy. Participants are randomly assigned to receive either tamsulosin or solifenacin, and symptom severity is assessed using the Ureteral Stent Symptom Questionnaire (USSQ).
Read the detailed description
Ureteral stents are widely used in urological procedures but are frequently associated with stent-related symptoms such as urinary urgency, pain, and reduced quality of life. These symptoms are believed to arise from mechanical irritation and bladder overactivity. Alpha-blockers and antimuscarinic agents are commonly prescribed to alleviate these effects. This study is designed to compare the effects of tamsulosin, an alpha-1 adrenergic receptor antagonist, and solifenacin, a muscarinic M3 receptor antagonist, in reducing DJ stent-related symptoms.
The study is a single-center, randomized clinical trial conducted at the Department of Urology, Liaquat National Hospital, Karachi. Sixty adult patients who undergo unilateral DJ stent placement for ureteric stones or after ureteroscopic lithotripsy are randomized into two equal groups. Group A receives tamsulosin 0.4 mg daily, and Group B receives solifenacin 5 mg daily. Symptom evaluation is performed on day 14 post-procedure using a culturally adapted version of the Ureteral Stent Symptom Questionnaire (USSQ), which assesses domains such as urinary symptoms, pain, general health, work performance, and sexual health.
The findings from this study aim to inform treatment decisions for managing stent-related symptoms in similar clinical populations.
- Being tested
- Tamsulosin, solifenacin
- Keywords
- Tamsulosin vs solifenacin in improving stent related symptoms, Double J stent, Tamsulosin, solifencin, ureteral stent-related symptoms, ussq, alpha-blocker, anticholinergic, RCT, quality of life
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TamsulosinDrug
Also called Tamsolin
Tamsulosin 0.4 mg once daily for 14 days
solifenacinDrug
Also called solifen
Solifenacin 5 mg once daily for 14 day
| Study group | Role | What they receive |
|---|---|---|
| Tamsulosin | Active comparator | Group A received tamsulosin starting within 24 hours after stent placement. Receives: Drug: Tamsulosin |
| Solifenacin | Active comparator | Group B received solifenacin starting within 24 hours after stent placement. Receives: Drug: solifenacin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in total USSQ score
Total score on the Ureteral Stent Symptom Questionnaire (USSQ), assessing pain, urinary symptoms, general health, work performance, and sexual health.
Measured: 14days post stent placement
Secondary outcomes (5)
Urinary index score
Measured: 14days
Pain index score
Measured: 14days
General Health Index score
Measured: 14days
Work Performance Index Score
Measured: 14days
Sexual Function Index Score
Measured: 14days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2025
- Study start13 Jun 2024
- Primary completion30 Dec 2024
- Study completion30 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ureteral Stent-Related SymptomStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Liaquat National Hospital & Medical College
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fareha Khan, Liaquat National Hospital & Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07114848
- Sponsor's protocol ID
- 0996-2024-LNH-ERC
- Status last verified
- Aug 2025
- First submitted
- 17 Jul 2025
- Last updated
- 11 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Efficacy of Tamsulosin and Solifenacin in Managing Double J Stent-Related Symptoms: A Randomized Clinical Study Using the USSQ Tool.
- ClinicalTrials.gov ID
- NCT07114848
- Acronym / sponsor ID
- 0996-2024-LNH-ERC
- Keywords
- Tamsulosin vs solifenacin in improving stent related symptoms, Double J stent, Tamsulosin, solifencin, ureteral stent-related symptoms, ussq, alpha-blocker, anticholinergic
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Liaquat National Hospital & Medical CollegeUniversity, hospital or other
- Study start
- 13 Jun 2024 (actual)
- Primary completion
- 30 Dec 2024 (actual)
- Study completion
- 30 Mar 2025 (actual)
- First posted
- 11 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study evaluates the effects of two medications-tamsulosin and solifenacin-on symptoms associated with double J (DJ) ureteral stents. The research is conducted among patients undergoing unilateral DJ stent placement for ureteric calculi or post-ureteroscopic lithotripsy. Participants are randomly assigned to receive either tamsulosin or solifenacin, and symptom severity is assessed using the Ureteral Stent Symptom Questionnaire (USSQ).
Detailed description
Ureteral stents are widely used in urological procedures but are frequently associated with stent-related symptoms such as urinary urgency, pain, and reduced quality of life. These symptoms are believed to arise from mechanical irritation and bladder overactivity. Alpha-blockers and antimuscarinic agents are commonly prescribed to alleviate these effects. This study is designed to compare the effects of tamsulosin, an alpha-1 adrenergic receptor antagonist, and solifenacin, a muscarinic M3 receptor antagonist, in reducing DJ stent-related symptoms.
The study is a single-center, randomized clinical trial conducted at the Department of Urology, Liaquat National Hospital, Karachi. Sixty adult patients who undergo unilateral DJ stent placement for ureteric stones or after ureteroscopic lithotripsy are randomized into two equal groups. Group A receives tamsulosin 0.4 mg daily, and Group B receives solifenacin 5 mg daily. Symptom evaluation is performed on day 14 post-procedure using a culturally adapted version of the Ureteral Stent Symptom Questionnaire (USSQ), which assesses domains such as urinary symptoms, pain, general health, work performance, and sexual health.
The findings from this study aim to inform treatment decisions for managing stent-related symptoms in similar clinical populations.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tamsulosin | Active comparator | Drug: TamsulosinGroup A received tamsulosin starting within 24 hours after stent placement. |
| Solifenacin | Active comparator | Drug: solifenacinGroup B received solifenacin starting within 24 hours after stent placement. |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Age 20 to 50 years
- Undergoing unilateral DJ stenting for:
- Ureteric calculi
- Post-ureteroscopic lithotripsy
Key exclusion criteria (7 listed)
- Bilateral stents
- History of LUTS or recurrent UTI
- Urological malignancy or bladder surgery
- Known hypersensitivity to alpha-blockers or anticholinergics
- Uncontrolled hypertension, cardiovascular instability
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TamsulosinAlso: TamsolinTamsulosin 0.4 mg once daily for 14 days | Drug | Tamsulosin |
| solifenacinAlso: solifenSolifenacin 5 mg once daily for 14 day | Drug | Solifenacin |
Primary outcome
Change in total USSQ score
Time frame: 14days post stent placement
Total score on the Ureteral Stent Symptom Questionnaire (USSQ), assessing pain, urinary symptoms, general health, work performance, and sexual health.
5 secondary outcomes
Urinary index score
Time frame: 14days
Pain index score
Time frame: 14days
General Health Index score
Time frame: 14days
Work Performance Index Score
Time frame: 14days
Sexual Function Index Score
Time frame: 14days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Tamsulosin and solifenacin in people with Ureteral Stent-Related Symptom and Alpha Blocker, run by Liaquat National Hospital & Medical College at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in total USSQ score (time frame: 14days post stent placement). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2025.