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

NCT ID: NCT02345980

Last Updated: 2017-06-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

94 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-03-31

Study Completion Date

2016-11-30

Brief Summary

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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.

Detailed Description

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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

Conditions

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Quality of Life

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Sildenafil

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

Group Type ACTIVE_COMPARATOR

Sildenafil

Intervention Type DRUG

Placebo

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Interventions

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Sildenafil

Intervention Type DRUG

Placebo

Intervention Type DRUG

Other Intervention Names

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Viagra

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Mansoura University

OTHER

Sponsor Role lead

Responsible Party

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Ahmed R. EL-Nahas

Urology & Nephrology Center

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ahmed R EL-Nahas, MD

Role: PRINCIPAL_INVESTIGATOR

Urology and Nephrology Center, Mansoura University, Egypt

Locations

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Urology and Nephrology Center, Mansoura University

Al Mansurah, , Egypt

Site Status

Countries

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Egypt

References

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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.

Reference Type DERIVED
PMID: 29766318 (View on PubMed)

Other Identifiers

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Sildenafil and USS

Identifier Type: -

Identifier Source: org_study_id

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