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

Mansoura University

Status and phase: Completed; Phase 4

Conditions: Quality of Life

Treatments: Drug: Placebo; Drug: Sildenafil

Study type: Interventional

Funder types: Other

Identifiers

NCT02345980

Sildenafil and USS

Details and patient eligibility

About

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.

Full 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

Enrollment: 94 patients

Sex: Male

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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94 participants in 2 patient groups, including a placebo group

Sildenafil

Active Comparator group

Description:

Patient in this arm will receive sildenafil citrate 50 mg tablet once daily after ureteral stent fixation.

Treatment:

Drug: Sildenafil

Placebo

Placebo Comparator group

Description:

Patient in this arm will receive placebo daily after ureteral stent fixation.

Treatment:

Drug: Placebo