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OpenTrials
Completed

NCT Number: NCT02345980

A Randomized Controlled Trial Evaluating Sildenafil Citrate in Relieving Ureteral Stent Related Symptoms

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.

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Key information

Conditions

Quality of Life

Age range

18 year–70 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 4

Primary location

Urology and Nephrology Center, Mansoura University

Al Mansurah, 35516, Egypt

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patient aged >18 years

Exclusion criteria

  • Patients who had LUTS before DJ stent fixation
  • DJ stent fixation after open surgery
  • Contraindication to Sildenafil citrate

Treatment and study plan

Sildenafil

Drug

Other names: Viagra

Placebo

Drug

Primary outcomes

  1. Ureteral Stent Symptoms Questionnaire (USSQ) Score

    Time frame: 2-4 weeks

    Comparison of total USSQ scores between study arms.

Secondary outcomes

  1. Number of participants with treatment-related adverse events

    Time frame: 2-4 weeks

    Analyzing frequency and severity of side effects of Sildenafil

Sponsors and collaborators

Lead sponsor

Mansoura University

Other

Registry information

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Jan 26, 2015
Registry last updated
Jun 28, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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