A Randomized Controlled Trial Evaluating Sildenafil Citrate in Relieving Ureteral Stent Related Symptoms
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|ClinicalTrials.gov Identifier: NCT02345980|
Recruitment Status : Completed
First Posted : January 26, 2015
Last Update Posted : June 28, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|Quality of Life||Drug: Sildenafil Drug: Placebo||Phase 4|
Adult patient (>18 years) who will undergo ureteral stent fixation after endoscopic procedures will be randomized between the study arms.
- Patients who had lower urinary tract symptoms before stent fixation.
- Ureteral stent fixation after open surgery.
- Known contraindications to Sildenafil Citrate
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||94 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Outcomes Assessor)|
|Official Title:||A Randomized Controlled Trial Evaluating Sildenafil Citrate in Relieving Ureteral Stent Related Symptoms|
|Actual Study Start Date :||March 2014|
|Actual Primary Completion Date :||November 2016|
|Actual Study Completion Date :||November 2016|
Active Comparator: Sildenafil
Patient in this arm will receive sildenafil citrate 50 mg tablet once daily after ureteral stent fixation.
Other Name: Viagra
Placebo Comparator: Placebo
Patient in this arm will receive placebo daily after ureteral stent fixation.
- Ureteral Stent Symptoms Questionnaire (USSQ) Score [ Time Frame: 2-4 weeks ]Comparison of total USSQ scores between study arms.
- Number of participants with treatment-related adverse events [ Time Frame: 2-4 weeks ]Analyzing frequency and severity of side effects of Sildenafil
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02345980
|Urology and Nephrology Center, Mansoura University|
|Mansoura, Egypt, 35516|
|Principal Investigator:||Ahmed R EL-Nahas, MD||Urology and Nephrology Center, Mansoura University, Egypt|