Relieve of Ureteral Stent SymptomsPhase 4NCT01880619
Comparison of Tamsulosin and Solifenacin in Treatment of Ureteral Stent Symptoms
A Phase 4 study testing Tamsulosin and Solifenacin in people with Relieve of Ureteral Stent Symptoms, run by Mansoura University at 1 site in Egypt.
Trial summary
This study will be conducted to compare the effectiveness of alpha blocker (Tamsulosin) and Anticholinergic (Solifenacin) in relieving lower urinary tract symptoms caused DJ ureteral stents. Read more about this study
- Who is it for?
- Ages 20 to 50 years
- Conditions the study is for
- Relieve of Ureteral Stent Symptoms
- What is being tested?
- Tamsulosin and Solifenacin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 131 participants
- Where
- 1 siteEgypt
- Study dates
- Jan 2013to Jul 2014
- 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
- Patient who will undergo unilateral ureteral stent fixation:
- To relieve upper urinary tract obstruction caused by ureteric calculi
- After ureteroscopic lithotripsy for ureteral calculi.
Who cannot join
- Patients who had LUTS before stent fixation.
- Ureteral stent fixation after open or laparoscopic surgery.
- Bilateral ureteral stents.
- Patients who developed complications related to the primary endoscopic procedure
- Patients who developed stent related complications such as hematuria, acute pyelonephritis or stent displacement
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Clinical Trial Comparing Alpha Blacker (Tamsulosin) and Anticholinergic (Solifenacin) in Treatment of Ureteral Stent Related Symptoms
This study will be conducted to compare the effectiveness of alpha blocker (Tamsulosin) and Anticholinergic (Solifenacin) in relieving lower urinary tract symptoms caused DJ ureteral stents.
Read the detailed description
Eligible patients who signed the informed consent will randomly assigned to one of 3 groups; group 1 (control), group 2 (tamsulosin) and group 3 (Solifenacin). Ureteral stent symptom questionnaire (USSQ) will be used to compare health related quality of life scores.
- Conditions
- Relieve of Ureteral Stent Symptoms
- Being tested
- Tamsulosin, Solifenacin, Control
- Keywords
- Double J, Ureteral stents, Symptoms, Alpha blockers, Anticholinergic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TamsulosinDrug
Also called Tamsulin
Patients in this arm will receive Tamsulosin 0.4 mg daily
SolifenacinDrug
Also called Sofinacin
Patients in the arm will receive Solifenacin
ControlDrug
Patients in this are will receive placebo
| Study group | Role | What they receive |
|---|---|---|
| Group A | Placebo comparator | Patients in this group will receive placebo Receives: Drug: Control |
| Group B | Active comparator | Patients in this group will receive Tamsulosin Receives: Drug: Tamsulosin |
| Group C | Active comparator | Patients in this group will receive Solifenacin Receives: Drug: Solifenacin |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Efficacy of tamsulosin and solifenacin in relieving ureteral stent symptoms will be evaluated by comparing the scores of ureteral stent symptoms questionnaire in the studied groups
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2013 (estimated)
- Study startJan 2013
- Primary completionMay 2014
- Study completionJul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Relieve of Ureteral Stent SymptomsStudies of the same condition, open and under way.
- More trials run by Mansoura 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 131 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed R. EL-Nahas, Mansoura University
- Investigators
- Ahmed R EL-Nahas, A. Professor, Principal investigator, urology and nephrology center mansoura university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01880619
- Sponsor's protocol ID
- Treatment of USS
- Status last verified
- Aug 2015
- First submitted
- 13 Jun 2013
- Last updated
- 25 Nov 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
El-Nahas AR, Tharwat M, Elsaadany M, Mosbah A, Gaballah MA. A randomized controlled trial comparing alpha blocker (tamsulosin) and anticholinergic (solifenacin) in treatment of ureteral stent-related symptoms. World J Urol. 2016 Jul;34(7):963-8. doi: 10.1007/s00345-015-1704-3. Epub 2015 Oct 9.
PubMed 26453222
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Clinical Trial Comparing Alpha Blacker (Tamsulosin) and Anticholinergic (Solifenacin) in Treatment of Ureteral Stent Related Symptoms
- ClinicalTrials.gov ID
- NCT01880619
- Acronym / sponsor ID
- Treatment of USS
- Conditions
- Relieve of Ureteral Stent Symptoms
- Keywords
- Double J, Ureteral stents, Symptoms, Alpha blockers, Anticholinergic
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 131 participants (actual)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- May 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 19 Jun 2013 (estimated)
- 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 will be conducted to compare the effectiveness of alpha blocker (Tamsulosin) and Anticholinergic (Solifenacin) in relieving lower urinary tract symptoms caused DJ ureteral stents.
Detailed description
Eligible patients who signed the informed consent will randomly assigned to one of 3 groups; group 1 (control), group 2 (tamsulosin) and group 3 (Solifenacin). Ureteral stent symptom questionnaire (USSQ) will be used to compare health related quality of life scores.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group A | Placebo comparator | Drug: ControlPatients in this group will receive placebo |
| Group B | Active comparator | Drug: TamsulosinPatients in this group will receive Tamsulosin |
| Group C | Active comparator | Drug: SolifenacinPatients in this group will receive Solifenacin |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- To relieve upper urinary tract obstruction caused by ureteric calculi
- After ureteroscopic lithotripsy for ureteral calculi.
Key exclusion criteria (5 listed)
- Patients who had LUTS before stent fixation.
- Ureteral stent fixation after open or laparoscopic surgery.
- Bilateral ureteral stents.
- Patients who developed complications related to the primary endoscopic procedure
- Patients who developed stent related complications such as hematuria, acute pyelonephritis or stent displacement
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: TamsulinPatients in this arm will receive Tamsulosin 0.4 mg daily | Drug | Group B |
| SolifenacinAlso: SofinacinPatients in the arm will receive Solifenacin | Drug | Group C |
| ControlPatients in this are will receive placebo | Drug | Group A |
Primary outcome
The Efficacy of tamsulosin and solifenacin in relieving ureteral stent symptoms will be evaluated by comparing the scores of ureteral stent symptoms questionnaire in the studied groups
Time frame: 1 year
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 25 Nov 2015.
- Derived from this study: PubMed 26453222El-Nahas AR, Tharwat M, Elsaadany M, Mosbah A, Gaballah MA. A randomized controlled trial comparing alpha blocker (tamsulosin) and anticholinergic (solifenacin) in treatment of ureteral stent-related symptoms. World J Urol. 2016 Jul;34(7):963-8. doi: 10.1007/s00345-015-1704-3. Epub 2015 Oct 9.
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.
Ahmed R EL-Nahas, A. Professor principal investigator
urology and nephrology center mansoura university
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 Relieve of Ureteral Stent Symptoms, run by Mansoura 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 3 inclusion and 5 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 25 Nov 2015. 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. Some participants in this study may receive a placebo. 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?
The Efficacy of tamsulosin and solifenacin in relieving ureteral stent symptoms will be evaluated by comparing the scores of ureteral stent symptoms questionnaire in the studied groups (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01880619, which also lists 1 linked publication.
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 25 Nov 2015.