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Sildenafil for Urinary Incontinence

Phase 2

Recruiting

Led By Kathy Vincent, MD

Research Sponsored by The University of Texas Medical Branch, Galveston

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Have urinary incontinence (UI), with at least 3 leakage episodes/week

Adults with spinal cord injury (SCI), 18-75 years of age, at the time of consent

Must not have

History of greater than 4 urinary tract infections per year

Multiple sclerosis

Timeline

Screening 3 weeks

Treatment Varies

Follow Up after 4 weeks of placebo treatment

Summary

This trial is testing whether sildenafil can help people with spinal cord injuries by reducing urine leakage.

Who is the study for?

This trial is for adults aged 18-75 with spinal cord injuries who experience urinary incontinence, having at least three leakage episodes per week. Participants must have a urodynamics assessment and be willing to follow study procedures. Excluded are those satisfied with their current quality of life due to urinary symptoms, using certain medications or treatments recently, pregnant or lactating women, and individuals with significant health issues like heart disease or active cancer.

What is being tested?

The study aims to see if sildenafil can reduce urine leakage in patients with spinal cord injuries compared to a placebo. It's designed as an experiment where participants don't know if they're getting the actual drug or a dummy pill (placebo).

What are the potential side effects?

Sildenafil may cause headaches, flushing, indigestion, nasal congestion, dizziness, vision changes like increased sensitivity to light or blurred vision. These side effects aren't guaranteed but are possible.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I experience urinary leaks at least 3 times a week.

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I am between 18 and 75 years old with a spinal cord injury.

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I experience urinary leakage at least 3 times a week.

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I am between 18 and 75 years old with a spinal cord injury.

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I experience urinary leaks at least 3 times a week.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had more than 4 urinary tract infections in a year.

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I have multiple sclerosis.

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I have a serious heart, liver, kidney, lung, blood, autoimmune or circulation condition.

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My blood pressure is within the safe range for sildenafil use.

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My cancer is currently active.

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I do not have HIV, Hepatitis B, or Hepatitis C.

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I am not pregnant or breastfeeding.

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My bladder condition puts me at risk for kidney injury.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ after 4 weeks of sildenafil treatment

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~after 4 weeks of sildenafil treatment

This trial's timeline: 3 weeks for screening, Varies for treatment, and after 4 weeks of sildenafil treatment for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Bladder Leakage as measured by 5 day bladder diary after 4 weeks of Placebo Treatment

Bladder Leakage as measured by 5 day bladder diary after 4 weeks of Sildenafil Treatment

Bladder Leakage as measured by 5 day bladder diary at Baseline

Secondary study objectives

Bladder dysfunction as measured by the Neurogenic Bladder Symptom Score after 4 weeks of placebo treatment

Bladder dysfunction as measured by the Neurogenic Bladder Symptom Score after 4 weeks of sildenafil treatment

Bladder dysfunction as measured by the Neurogenic Bladder Symptom Score at baseline

+15 more

Side effects data

From 2013 Phase 4 trial • 105 Patients • NCT00323297

14%

Diarrhoea

14%

Oedema peripheral

14%

Headache

10%

Flushing

10%

Bronchitis

10%

Vertigo

10%

Palpitations

10%

Nasopharyngitis

Respiratory tract infection

Depression

Dyspnoea

Right ventricular failure

Vision blurred

Presyncope

Pulmonary hypertension

Anaemia

Upper respiratory tract infection

Pulmonary arterial hypertension

Bronchopneumonia

Nausea

Cough

Uterine haemorrhage

Acute coronary syndrome

Death

Breast cancer

Cardiovascular disorder

Haemoglobin decreased

Skin ulcer

Back pain

Haemoptysis

Hypoxia

Chest discomfort

Walking distance test abnormal

Coronary artery disease

Cardiac failure

Pancreatic neoplasm

Mitral valve incompetence

Inguinal hernia

Circulatory collapse

General physical health deterioration

Urinary tract infection

Asthenia

Respiratory syncytial virus infection

Gangrene

Sinusitis

Hypertension

100%

80%

60%

40%

20%

Study treatment Arm

Placebo

Sildenafil

Trial Design

2Treatment groups

Experimental Treatment

Group I: Sildenafil 20mg TID then Placebo TIDExperimental Treatment2 Interventions

Subjects will be administered Sildenafil 20mg TID for 4 weeks. There will be a 2 week washout period then subjects will be administered Placebo (lactose) TID for 4 weeks.

Group II: Placebo TID then Sildenafil 20mg TIDExperimental Treatment2 Interventions

Subjects will be administered Placebo (lactose) TID for 4 week. There will be a 2 week washout period and then subjects will be administered Sildenafil 20mg TID for 4 weeks.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Sildenafil Citrate

2021

Completed Phase 4

~1590

Placebo

1995

Completed Phase 3

~2670