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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
Sponsor:
Information provided by (Responsible Party):
Ahmed R. EL-Nahas, Mansoura University

Brief 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%.

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

Detailed Description:

Adult patient (>18 years) who will undergo ureteral stent fixation after endoscopic procedures will be randomized between the study arms.

Exclusion criteria:

  1. Patients who had lower urinary tract symptoms before stent fixation.
  2. Ureteral stent fixation after open surgery.
  3. Known contraindications to Sildenafil Citrate

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 94 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Sildenafil
Patient in this arm will receive sildenafil citrate 50 mg tablet once daily after ureteral stent fixation.
Drug: Sildenafil
Other Name: Viagra

Placebo Comparator: Placebo
Patient in this arm will receive placebo daily after ureteral stent fixation.
Drug: Placebo



Primary Outcome Measures :
  1. Ureteral Stent Symptoms Questionnaire (USSQ) Score [ Time Frame: 2-4 weeks ]
    Comparison of total USSQ scores between study arms.


Secondary Outcome Measures :
  1. Number of participants with treatment-related adverse events [ Time Frame: 2-4 weeks ]
    Analyzing frequency and severity of side effects of Sildenafil



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

1. Patient aged >18 years

Exclusion Criteria:

  1. Patients who had LUTS before DJ stent fixation
  2. DJ stent fixation after open surgery
  3. Contraindication to Sildenafil citrate

Information from the National Library of Medicine

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


Locations
Egypt
Urology and Nephrology Center, Mansoura University
Mansoura, Egypt, 35516
Sponsors and Collaborators
Mansoura University
Investigators
Principal Investigator: Ahmed R EL-Nahas, MD Urology and Nephrology Center, Mansoura University, Egypt

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Ahmed R. EL-Nahas, Urology & Nephrology Center, Mansoura University
ClinicalTrials.gov Identifier: NCT02345980     History of Changes
Other Study ID Numbers: Sildenafil and USS
First Posted: January 26, 2015    Key Record Dates
Last Update Posted: June 28, 2017
Last Verified: June 2017

Additional relevant MeSH terms:
Citric Acid
Sildenafil Citrate
Anticoagulants
Calcium Chelating Agents
Chelating Agents
Sequestering Agents
Molecular Mechanisms of Pharmacological Action
Vasodilator Agents
Phosphodiesterase 5 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Urological Agents