Sildenafil for Urinary Incontinence

Age: 18+

Sex: Female

Trial Phase: Phase 1

Sponsor: The University of Texas Medical Branch, Galveston

Must not be taking: Nitrates, Steroids, Alpha blockers

Disqualifiers: Heart disease, Diabetes, Cancer, others

Approved in 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 10 weeks

24 Participants Needed

Trial Summary

What is the purpose of this trial?

The investigators goal is to develop medical treatments for stress/mixed urinary incontinence. Sildenafil has been shown to improve blood flow as well as muscle mass and strength and to decrease muscle fatigue. The investigators believe that it will improve muscular atrophy in the pelvic floor, thus improving symptoms of urinary incontinence related to pelvic floor dysfunction.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you plan to continue using urinary incontinence medications during the study. Also, you should not have used systemic nitrates, anabolic steroids, corticosteroids, or alpha blockers recently.

What data supports the effectiveness of the drug Sildenafil for urinary incontinence?

While there is no direct evidence for Sildenafil's effectiveness in treating urinary incontinence, studies have shown that similar drugs, like Tadalafil, can help with lower urinary tract symptoms. Additionally, Sildenafil has been effective in treating erectile dysfunction, which suggests it may have potential benefits for urinary issues due to its action on blood flow and muscle relaxation. ^{1 2 3 4 5}

Is sildenafil generally safe for humans?

Sildenafil, known by various names like Viagra and Revatio, has been used by millions of people worldwide for conditions like erectile dysfunction. Studies show it is generally well-tolerated, with most side effects being mild or moderate, such as headaches or dizziness, and rarely causing people to stop treatment. ^{2 6 7 8 9}

How is the drug sildenafil unique for treating urinary incontinence?

Sildenafil, commonly known for treating erectile dysfunction, is being explored for urinary incontinence due to its ability to improve lower urinary tract symptoms, which is different from traditional treatments that often focus on muscle relaxation or bladder control. ^{1 2 10 11 12}

Research Team

Kathleen L Vincent, MD

Principal Investigator

University of Texas

Eligibility Criteria

This trial is for postmenopausal women aged 50-80 with stress or mixed urinary incontinence, experiencing at least three episodes a week. Participants should be able to follow the study procedures and provide consent. Excluded are those with significant health issues like heart or liver disease, active cancer, untreated endocrine diseases, high BMI (>40), certain infections (HIV/Hepatitis), or on conflicting medications.

Inclusion Criteria

I am a woman aged 50-80 and have gone through menopause.

Willing and able to comply with study procedures

Willing and able to provide written informed consent

Exclusion Criteria

I am currently taking and plan to keep taking medication for urinary incontinence.

I am not pregnant or breastfeeding.

My cancer is currently active.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either Sildenafil or placebo for 10 weeks to assess its effect on urinary incontinence

10 weeks

Regular visits for assessment and monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Sildenafil

Trial Overview The trial is testing Sildenafil's effectiveness against urinary incontinence by improving pelvic floor muscle function. Women will either receive Sildenafil or a placebo to see if there's an improvement in their symptoms compared to those not receiving the drug.

Participant Groups

Group I: Sildenafil Active Control 1 Intervention

Double Blind Sildenafil, 20mg x 3 times a day, 10 weeks.

Group II: Placebo Placebo Group 1 Intervention

Double Blind Placebo 3 times a day for 10 weeks.

Sildenafil is already approved in United States, European Union, Canada, Japan for the following indications:

Approved in United States as Viagra for:

• Erectile dysfunction
• Pulmonary arterial hypertension

Approved in European Union as Viagra for:

• Erectile dysfunction
• Pulmonary arterial hypertension

Approved in United States as Revatio for:

• Pulmonary arterial hypertension

Approved in Canada as Sildenafil for:

• Erectile dysfunction
• Pulmonary arterial hypertension

Approved in Japan as Sildenafil for:

• Erectile dysfunction
• Pulmonary arterial hypertension

Who Is Running the Clinical Trial?

The University of Texas Medical Branch, Galveston

Lead Sponsor

Trials

263

Recruited

55,400+

Findings from Research

Sildenafil citrate (Viagra) has been prescribed to over 10 million patients and has shown significant improvements in erectile function across various conditions, including diabetes and cardiovascular disease, based on clinical trials.

The medication is generally well-tolerated, with most side effects being mild or moderate and rarely causing patients to stop treatment, indicating its safety in a wide range of patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Three-year update of sildenafil citrate (Viagra) efficacy and safety. Sadovsky, R., Miller, T., Moskowitz, M., et al.[2022]

A large observational study involving 22,471 patients found that sildenafil, used primarily for erectile dysfunction, has a safety profile consistent with expectations, with no unexpected adverse drug reactions reported.

The study showed that the standardized mortality ratio for deaths due to ischemic heart disease in patients taking sildenafil was not higher than that of the general male population in England, indicating no increased risk associated with the medication.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of the safety of sildenafil for male erectile dysfunction: experience gained in general practice use in England in 1999. Boshier, A., Wilton, LV., Shakir, SA.[2015]

References

1. Spain pubmed.ncbi.nlm.nih.gov

The efficacy of Tadalafil 5mg in the treatment of lower urinary tract symptoms in patients where alpha blocker treatments have failed in terms of lower urinary tract symptoms. [2022]

2. India pubmed.ncbi.nlm.nih.gov

Three-year update of sildenafil citrate (Viagra) efficacy and safety. [2022]

3. Netherlands pubmed.ncbi.nlm.nih.gov

Real-life safety and efficacy of vardenafil in the treatment of erectile dysfunction-results from 30,010 U.S. patients. [2022]

4. Netherlands pubmed.ncbi.nlm.nih.gov

Combination Therapy with Alpha-blocker and Phosphodiesterase-5 Inhibitor for Improving Lower Urinary Tract Symptoms and Erectile Dysfunction in Comparison with Monotherapy: A Systematic Review and Meta-analysis. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

A new era in the treatment of erectile dysfunction. [2019]

6. England pubmed.ncbi.nlm.nih.gov

Evaluation of the safety of sildenafil for male erectile dysfunction: experience gained in general practice use in England in 1999. [2015]

7. Iran pubmed.ncbi.nlm.nih.gov

Sildenafil Vs. Tadalafil for The Treatment of Benign Prostatic Hyperplasia: A Single-arm Self-controlled Clinical Trial. [2023]

8. United States pubmed.ncbi.nlm.nih.gov

Effect of sildenafil in patients with erectile dysfunction taking antihypertensive therapy. Sildenafil Study Group. [2023]

9. England pubmed.ncbi.nlm.nih.gov

The effect of sildenafil citrate on bladder outlet obstruction: a mouse model. [2015]

10. England pubmed.ncbi.nlm.nih.gov

Pre-clinical evidence for the use of phosphodiesterase-5 inhibitors for treating benign prostatic hyperplasia and lower urinary tract symptoms. [2022]

11. England pubmed.ncbi.nlm.nih.gov

The mesh wallstent in the treatment of detrusor external sphincter dyssynergia in men with spinal cord injury: a 12-year follow-up. [2019]

12. United States pubmed.ncbi.nlm.nih.gov

Sildenafil citrate improves erectile function and urinary symptoms in men with erectile dysfunction and lower urinary tract symptoms associated with benign prostatic hyperplasia: a randomized, double-blind trial. [2023]