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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether sildenafil, a drug known for improving blood flow and muscle strength, can help with stress or mixed urinary incontinence. Researchers believe it may strengthen pelvic floor muscles, reducing urine leakage symptoms. Participants will receive either sildenafil or a placebo for 10 weeks to evaluate the treatment's effectiveness. Women who are postmenopausal and experience at least three episodes of urine leakage per week might be suitable for this study. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants a chance to contribute to groundbreaking research.

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.

Is there any evidence suggesting that this treatment is likely to be safe for humans?

Previous studies have used sildenafil safely for various conditions. It is best known for treating erectile dysfunction. Research has shown it may also help with urinary problems. For example, men taking sildenafil reported better urinary symptoms and an improved quality of life, suggesting the drug might be well-tolerated.

The FDA has approved sildenafil for other uses, providing some reassurance about its safety. However, specific safety information is limited when used for new conditions like urinary incontinence. As this is a Phase 1 trial, researchers are specifically studying its safety for urinary incontinence, even though sildenafil is already known to be safe for other uses. Early trials focus heavily on safety, so participants will be closely monitored. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for urinary incontinence?

Most treatments for urinary incontinence focus on muscle control or hormone regulation. But Sildenafil, commonly known for treating erectile dysfunction, works differently by enhancing blood flow through the relaxation of blood vessels. Researchers are excited about its potential because this unique mechanism might improve bladder function more effectively. Additionally, the use of Sildenafil offers a new approach by repurposing a well-known drug for a different condition, which could lead to quicker adoption if successful.

What evidence suggests that Sildenafil might be an effective treatment for urinary incontinence?

Research has shown that Sildenafil can improve blood flow, potentially aiding urinary incontinence by strengthening pelvic muscles. This trial will compare Sildenafil with a placebo to assess its impact on urinary incontinence. Some studies have found that Sildenafil does not significantly alter urine flow or the amount of urine remaining in the bladder after urination compared to a placebo. While the concept is promising, solid evidence of its effectiveness for urinary incontinence remains limited. Further research is needed to confirm its potential benefits for this condition. ^{1 3 4 6 7}

Who Is on the Research Team?

Kathleen L Vincent, MD

Principal Investigator

University of Texas

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/17296414/

Sildenafil citrate improves erectile function and urinary ... Conclusions: Improved erectile dysfunction and lower urinary tract symptoms with sildenafil in men with the 2 conditions were associated with improved quality ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT04565925

Sildenafil for Treatment of Urinary Incontinence in Patients ... Results will be reported as mL urine remaining. after 4 weeks of sildenafil treatment. Post void residual urine volume as measured by ultrasound bladder scanner ...

3. withpower.com withpower.com/trial/phase-1-urinary-incontinence-2-2017-d4943

Sildenafil for Urinary Incontinence · Info for Participants 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 ...

4. clinicaltrial.be clinicaltrial.be/en/details/9528?per_page=100&recruiting=1&enrolling_by_invitation=1&active_not_recruiting=1&not_yet_recruiting=0&completed=0&only_recruiting=0&only_eligible=0

Use of Sildenafil for Treatment of Urinary Incontinence -... Secondary outcomes will include evaluation of muscle and vaginal mucosal thickness. Interventions 2 ...

5. europeanurology.com europeanurology.com/article/S0302-2838(06)00704-4/pdf

Results of Double-Blind Placebo-Controlled ... Sildenafil was found to show no significant phar- macologic effect in altering flow rates and residual volumes when compared with placebo in this cohort of ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4707894/

Nightly sildenafil use after radical prostatectomy has ... In a randomized controlled study, nightly use of sildenafil was associated with decreased urinary function scores using the EPIC questionnaire.

7. accessdata.fda.gov accessdata.fda.gov/drugsatfda_docs/label/2014/20895s039s042lbl.pdf

Label: VIAGRA (sildenafil citrate) tablets - accessdata.fda.gov There are no controlled clinical data on the safety or efficacy of VIAGRA in the following groups; if prescribed, this should be done with caution ...