Quality of LifePhase 4NCT02345980
A Randomized Controlled Trial Evaluating Sildenafil Citrate in Relieving Ureteral Stent Related Symptoms
A Phase 4 study testing Sildenafil in people with Quality of Life, run by Mansoura University at 1 site in Egypt.
Trial summary
Despite its beneficial effect, ureteral stents may produce symptoms (such as hematuria, dysuria, frequency, urgency, urge incontinence and suprapubic or flank pain) that affect the quality of life in 70-80%. Read more about this study
- Who is it for?
- Ages 18 to 70 years, men only
- Conditions the study is for
- Quality of Life
- What is being tested?
- Sildenafil
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 94 participants
- Where
- 1 siteEgypt
- Study dates
- Mar 2014to Nov 2016
- 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 18 to 70 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1. Patient aged >18 years
Who cannot join
- Patients who had LUTS before DJ stent fixation
- DJ stent fixation after open surgery
- Contraindication to Sildenafil citrate
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Urology and Nephrology Center, Mansoura University
Al Mansurah, 35516
About this study
Despite its beneficial effect, ureteral stents may produce symptoms (such as hematuria, dysuria, frequency, urgency, urge incontinence and suprapubic or flank pain) that affect the quality of life in 70-80%.
This study will be conducted to evaluate the role of Phosphodiestrase 5 inhibitor (Sildenafil Citrate) in relieving these symptoms.
Read the detailed description
Adult patient (>18 years) who will undergo ureteral stent fixation after endoscopic procedures will be randomized between the study arms.
Exclusion criteria:
- Patients who had lower urinary tract symptoms before stent fixation.
- Ureteral stent fixation after open surgery.
- Known contraindications to Sildenafil Citrate
- Conditions
- Quality of Life
- Being tested
- Sildenafil, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SildenafilDrug
Also called Viagra
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Sildenafil | Active comparator | Patient in this arm will receive sildenafil citrate 50 mg tablet once daily after ureteral stent fixation. Receives: Drug: Sildenafil |
| Placebo | Placebo comparator | Patient in this arm will receive placebo daily after ureteral stent fixation. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ureteral Stent Symptoms Questionnaire (USSQ) Score
Comparison of total USSQ scores between study arms.
Measured: 2-4 weeks
Secondary outcomes (1)
Number of participants with treatment-related adverse events
Analyzing frequency and severity of side effects of Sildenafil
Measured: 2-4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2015 (estimated)
- Study startMar 2014
- Primary completionNov 2016
- Study completionNov 2016
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 Quality of LifeStudies 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 94 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, MD, Principal investigator, Urology and Nephrology Center, Mansoura University, Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02345980
- Sponsor's protocol ID
- Sildenafil and USS
- Status last verified
- Jun 2017
- First submitted
- 1 Oct 2014
- Last updated
- 28 Jun 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Tharwat M, Elsaadany MM, Lashin AM, El-Nahas AR. A randomized controlled trial evaluating sildenafil citrate in relieving ureteral stent-related symptoms. World J Urol. 2018 Nov;36(11):1877-1881. doi: 10.1007/s00345-018-2339-y. Epub 2018 May 15.
PubMed 29766318
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial Evaluating Sildenafil Citrate in Relieving Ureteral Stent Related Symptoms
- ClinicalTrials.gov ID
- NCT02345980
- Acronym / sponsor ID
- Sildenafil and USS
- Conditions
- Quality of Life
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 94 participants (actual)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- Mar 2014 (actual)
- Primary completion
- Nov 2016 (actual)
- Study completion
- Nov 2016 (actual)
- First posted
- 26 Jan 2015 (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.
Despite its beneficial effect, ureteral stents may produce symptoms (such as hematuria, dysuria, frequency, urgency, urge incontinence and suprapubic or flank pain) that affect the quality of life in 70-80%.
This study will be conducted to evaluate the role of Phosphodiestrase 5 inhibitor (Sildenafil Citrate) in relieving these symptoms.
Detailed description
Adult patient (>18 years) who will undergo ureteral stent fixation after endoscopic procedures will be randomized between the study arms.
Exclusion criteria:
- Patients who had lower urinary tract symptoms before stent fixation.
- Ureteral stent fixation after open surgery.
- Known contraindications to Sildenafil Citrate
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sildenafil | Active comparator | Drug: SildenafilPatient in this arm will receive sildenafil citrate 50 mg tablet once daily after ureteral stent fixation. |
| Placebo | Placebo comparator | Drug: PlaceboPatient in this arm will receive placebo daily after ureteral stent fixation. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 1. Patient aged >18 years
Key exclusion criteria (3 listed)
- Patients who had LUTS before DJ stent fixation
- DJ stent fixation after open surgery
- Contraindication to Sildenafil citrate
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 |
|---|---|---|
| SildenafilAlso: Viagra | Drug | Sildenafil |
| Placebo | Drug | Placebo |
Primary outcome
Ureteral Stent Symptoms Questionnaire (USSQ) Score
Time frame: 2-4 weeks
Comparison of total USSQ scores between study arms.
1 secondary outcome
Number of participants with treatment-related adverse events
Time frame: 2-4 weeks
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 28 Jun 2017.
- Derived from this study: PubMed 29766318Tharwat M, Elsaadany MM, Lashin AM, El-Nahas AR. A randomized controlled trial evaluating sildenafil citrate in relieving ureteral stent-related symptoms. World J Urol. 2018 Nov;36(11):1877-1881. doi: 10.1007/s00345-018-2339-y. Epub 2018 May 15.
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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.
Ahmed R EL-Nahas, MD principal investigator
Urology and Nephrology Center, Mansoura University, Egypt
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 Sildenafil in people with Quality of Life, 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 1 inclusion and 3 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 28 Jun 2017. 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?
Ureteral Stent Symptoms Questionnaire (USSQ) Score (time frame: 2-4 weeks). 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 NCT02345980, 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 28 Jun 2017.