Management of Ureteric Stent Related LUTS and PainPhase 1/2NCT07206706
Efficacy and Tolerability of Tadalafil Versus Darifenacin in Management of Ureteric Stent-Related LUTS
A Phase 1/2 study testing Tadalafil 5Mg Tab and Darifenacin 7.5 MG in people with Management of Ureteric Stent Related LUTS and Pain, run by Ain Shams University at 1 site in Egypt.
Trial summary
This randomized, crossover clinical trial evaluated the efficacy and safety of tadalafil compared with darifenacin in managing lower urinary tract symptoms (LUTS) and pain related to indwelling ureteric stents. Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Management of Ureteric Stent Related LUTS and Pain
- What is being tested?
- Tadalafil 5Mg Tab and Darifenacin 7.5 MG
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteEgypt
- Study dates
- 1 May 2022to 28 Dec 2022
- Phase
- Phase 1/2
- 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 18 to 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age:18-40 years
- Patient with ureteric stent size 6 Fr-26 cm post endoscopic procedure.
Who cannot join
- Known prostatic patient with LUTS
- Pregnant or lactating women
- Recurrent urinary tract infection.
- Neurological diseases.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy and Tolerability of Tadalafil 5mg Once Daily Versus Darifenacin for Ureteric Stent Related Symptoms
This randomized, crossover clinical trial evaluated the efficacy and safety of tadalafil compared with darifenacin in managing lower urinary tract symptoms (LUTS) and pain related to indwelling ureteric stents. A total of 150 patients who underwent ureteric stent insertion after endoscopic treatment of ureteric stones were enrolled. Patients were randomized into two groups: Group 1 received tadalafil 5 mg once daily for 3 weeks, followed by a 1-week washout, then darifenacin 7.5 mg once daily for 3 weeks. Group 2 received the reverse sequence.
The primary outcome was change in LUTS as measured by a shortened International Prostate Symptom Score (IPSS). The secondary outcome was stent-related pain measured by the Numeric Pain Rating Scale (NPRS). Drug safety and tolerability were also assessed.
- Being tested
- Tadalafil 5Mg Tab, Darifenacin 7.5 MG
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tadalafil 5Mg TabDrug
PDE5 inhibitor
Darifenacin 7.5 MGDrug
anti muscarinic
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | in the 1st phase Group 1 received Tadalafil 5 mg tab once daily orally and switched to Darifenacin 7.5 mg once daily orally in the 2nd phase Receives: Drug: Tadalafil 5Mg Tab; Drug: Darifenacin 7.5 MG |
| Group 2 | Experimental | in the 1st phase: group 2 received darifenacin 7.5 mg once daily orally and switched to tadalafil 5 mg once daily orally in the 2nd phase of the study Receives: Drug: Tadalafil 5Mg Tab; Drug: Darifenacin 7.5 MG |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in stent related lower urinary tract symptoms (LUTS)
Change from baseline in stent-related symptoms, measured by a shortened International Prostate Symptom Score (IPSS), including incomplete emptying (Q1) and storage domain (Q2, Q4, Q7). The score was calculated (minimum 0 and maximum 20) according to patients' answers to the questions Higher scores indicate worse symptoms.
Measured: 3 weeks
Change in numerical Pain rating score (NPRS)
Change from baseline in ureteric stent-related pain, measured by the Numeric Pain Rating Scale (0 = no pain, 10 = worst pain).
Measured: 3 weeks
Secondary outcomes (1)
Incidence of Adverse Events
Number and type of drug-related adverse events (e.g., dry mouth, constipation, headache, flushing, myalgia), recorded during each treatment phase.
Measured: Throughout the 7-week study period (3 weeks first drug, 1 week washout, 3 weeks second drug)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2025
- Study start1 May 2022
- Primary completion14 Dec 2022
- Study completion28 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Management of Ureteric Stent Related LUTS and PainStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- hossam M elawady, MD, Principal investigator, urology department, Ain shams university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07206706
- Sponsor's protocol ID
- FMASU MS221/2022
- Status last verified
- Mar 2022
- First submitted
- 26 Sep 2025
- Last updated
- 16 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The datasets generated and analyzed during the current study will not be publicly available due to institutional restrictions, but are available from the corresponding author on reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Tolerability of Tadalafil 5mg Once Daily Versus Darifenacin for Ureteric Stent Related Symptoms
- ClinicalTrials.gov ID
- NCT07206706
- Acronym / sponsor ID
- FMASU MS221/2022
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 May 2022 (actual)
- Primary completion
- 14 Dec 2022 (actual)
- Study completion
- 28 Dec 2022 (actual)
- First posted
- 3 Oct 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 randomized, crossover clinical trial evaluated the efficacy and safety of tadalafil compared with darifenacin in managing lower urinary tract symptoms (LUTS) and pain related to indwelling ureteric stents. A total of 150 patients who underwent ureteric stent insertion after endoscopic treatment of ureteric stones were enrolled. Patients were randomized into two groups: Group 1 received tadalafil 5 mg once daily for 3 weeks, followed by a 1-week washout, then darifenacin 7.5 mg once daily for 3 weeks. Group 2 received the reverse sequence.
The primary outcome was change in LUTS as measured by a shortened International Prostate Symptom Score (IPSS). The secondary outcome was stent-related pain measured by the Numeric Pain Rating Scale (NPRS). Drug safety and tolerability were also assessed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Drug: Tadalafil 5Mg Tab, Drug: Darifenacin 7.5 MGin the 1st phase Group 1 received Tadalafil 5 mg tab once daily orally and switched to Darifenacin 7.5 mg once daily orally in the 2nd phase |
| Group 2 | Experimental | Drug: Tadalafil 5Mg Tab, Drug: Darifenacin 7.5 MGin the 1st phase: group 2 received darifenacin 7.5 mg once daily orally and switched to tadalafil 5 mg once daily orally in the 2nd phase of the study |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Age:18-40 years
- Patient with ureteric stent size 6 Fr-26 cm post endoscopic procedure.
Key exclusion criteria (4 listed)
- Known prostatic patient with LUTS
- Pregnant or lactating women
- Recurrent urinary tract infection.
- Neurological diseases.
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 |
|---|---|---|
| Tadalafil 5Mg TabPDE5 inhibitor | Drug | Group 1, Group 2 |
| Darifenacin 7.5 MGanti muscarinic | Drug | Group 1, Group 2 |
Primary outcome
change in stent related lower urinary tract symptoms (LUTS)
Time frame: 3 weeks
Change from baseline in stent-related symptoms, measured by a shortened International Prostate Symptom Score (IPSS), including incomplete emptying (Q1) and storage domain (Q2, Q4, Q7). The score was calculated (minimum 0 and maximum 20) according to patients' answers to the questions Higher scores indicate worse symptoms.
Change in numerical Pain rating score (NPRS)
Time frame: 3 weeks
Change from baseline in ureteric stent-related pain, measured by the Numeric Pain Rating Scale (0 = no pain, 10 = worst pain).
1 secondary outcome
Incidence of Adverse Events
Time frame: Throughout the 7-week study period (3 weeks first drug, 1 week washout, 3 weeks second drug)
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 16 Jan 2026.
- Individual participant dataSharing planned: No. The datasets generated and analyzed during the current study will not be publicly available due to institutional restrictions, but are available from the corresponding author on reasonable request.
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.
hossam M elawady, MD principal investigator
urology department, Ain shams university
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Tadalafil 5Mg Tab and Darifenacin 7.5 MG in people with Management of Ureteric Stent Related LUTS and Pain, run by Ain Shams University at 1 site in Egypt.
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 2 inclusion and 4 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 16 Jan 2026. 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 Egypt. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 stent related lower urinary tract symptoms (LUTS) (time frame: 3 weeks). The study lists 2 primary outcomes in all. 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 16 Jan 2026.