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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.
Adult patient (>18 years) who will undergo ureteral stent fixation after endoscopic procedures will be randomized between the study arms.
Exclusion criteria:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sildenafil | Active Comparator | Patient in this arm will receive sildenafil citrate 50 mg tablet once daily after ureteral stent fixation. |
|
| Placebo | Placebo Comparator | Patient in this arm will receive placebo daily after ureteral stent fixation. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sildenafil | Drug |
|
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Ureteral Stent Symptoms Questionnaire (USSQ) Score | Comparison of total USSQ scores between study arms. | 2-4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with treatment-related adverse events | Analyzing frequency and severity of side effects of Sildenafil | 2-4 weeks |
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Inclusion Criteria:
1. Patient aged >18 years
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ahmed R EL-Nahas, MD | Urology and Nephrology Center, Mansoura University, Egypt | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Urology and Nephrology Center, Mansoura University | Al Mansurah | 35516 | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29766318 | Derived | 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. |
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| ID | Term |
|---|---|
| D000068677 | Sildenafil Citrate |
| ID | Term |
|---|---|
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D013450 | Sulfones |
| D013457 |
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| Drug |
|
| Sulfur Compounds |
| D010879 | Piperazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |