Testosterone for Stress Incontinence

Overseen By Shalender Bhasin, MB,BS

Age: 18+

Sex: Female

Trial Phase: Phase 2

Sponsor: Brigham and Women's Hospital

Must not be taking: Systemic estrogen, Insulin

Disqualifiers: Urge incontinence, Pelvic surgery, Neurologic disorders, Cancer, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 12

Duration: 12 weeks

30 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether testosterone therapy can help women with stress urinary incontinence, a condition where physical activities like coughing or sneezing cause urine leakage. Researchers aim to determine if testosterone can strengthen pelvic floor muscles and improve bladder control. Participants will receive weekly injections of either testosterone cypionate (a form of testosterone) or a placebo (a substance with no active medication). Women with medically confirmed stress urinary incontinence, who are not involved in certain other treatments or have specific health conditions, may be suitable for this trial. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to important advancements in managing stress urinary incontinence.

Do I need to stop my current medications for the trial?

The trial information does not specify if you need to stop taking your current medications. However, if you are on insulin therapy or systemic estrogen therapy, you would not be eligible to participate.

Is there any evidence suggesting that testosterone cypionate is likely to be safe for humans?

Research is exploring whether testosterone cypionate can help with stress urinary incontinence, particularly in older postmenopausal women. This treatment aims to strengthen pelvic floor muscles and improve bladder control.

Regarding safety, the FDA has already approved testosterone for other uses, such as treating low testosterone levels in men, suggesting general safety for humans. However, this does not automatically ensure safety for treating stress urinary incontinence in women.

The study seeks to determine if the treatment has manageable side effects for women with stress incontinence. The current phase of the trial indicates some confidence in its safety, but the study will provide more detailed information about patient tolerance. Individual experiences may vary, and participating in a trial helps gather important data on safety and effectiveness. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard treatments for stress incontinence, which typically include pelvic floor exercises, medications like anticholinergics, or surgical interventions, testosterone cypionate offers a novel approach by utilizing a hormone therapy. This treatment is unique because it involves weekly intramuscular injections of testosterone cypionate, potentially strengthening pelvic muscles and improving bladder control. Researchers are excited about this treatment because it represents a different mechanism of action, focusing on hormonal support to address the condition, which could provide an alternative for patients who do not respond well to traditional therapies.

What evidence suggests that testosterone might be an effective treatment for stress incontinence?

This trial will compare Testosterone Cypionate with a placebo to evaluate its effects on stress urinary incontinence in women. Research has shown that testosterone therapy might help with this condition. One study found that testosterone can strengthen pelvic floor muscles, aiding in urine flow control. Another study demonstrated that testosterone therapy might improve bladder function, easing urinary symptoms. Importantly, these studies suggest that testosterone does not worsen urinary issues, making it a promising option. While more research is needed, early findings are hopeful about testosterone's potential benefits for stress urinary incontinence. ^{1 2 6 7 8}

Who Is on the Research Team?

Grace Huang, MD

Principal Investigator

Brigham and Women's Hospital

Are You a Good Fit for This Trial?

This trial is for women aged 60 and older with medically confirmed stress urinary incontinence. Participants must have a normal mammogram from the last year and, if they have a uterus, an endometrial thickness of ≤4 mm. They need to be able to give informed consent.

Inclusion Criteria

I have been diagnosed with stress urinary incontinence.

My endometrial thickness is 4 mm or less, confirmed by ultrasound.

You are capable of and willing to provide informed consent.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either testosterone or placebo intramuscular injections weekly to assess the anabolic effect on pelvic floor muscles

12 weeks

12 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Testosterone cypionate

Trial Overview The study tests whether testosterone therapy can strengthen pelvic floor muscles and improve urinary function in postmenopausal women with stress urinary incontinence. It's a randomized, double-blind trial comparing testosterone cypionate injections against placebo.

How Is the Trial Designed?

Group I: Testosterone Active Control 1 Intervention

Testosterone Cypionate 25-mg weekly by intramuscular injection

Group II: Placebo Placebo Group 1 Intervention

Placebo intramuscular injections weekly

Who Is Running the Clinical Trial?

Brigham and Women's Hospital

Lead Sponsor

Trials

1,694

Recruited

14,790,000+

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborator

Trials

2,513

Recruited

4,366,000+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06111209

The Anabolic Effect of Testosterone on Pelvic Floor Muscles The investigators are conducting a 12-week double-blind, randomized-controlled, proof-of-concept pilot trial to determine the anabolic effect of testosterone ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5182217/

Testosterone replacement therapy and voiding dysfunction The current evidence suggests that not only does TRT not worsen lower urinary tract symptoms (LUTS), but that hypogonadism itself is an important risk factor ...

3. withpower.com withpower.com/trial/testosterone-for-stress-incontinence-14148

Testosterone for Stress Incontinence Trial Overview The study tests whether testosterone therapy can strengthen pelvic floor muscles and improve urinary function in postmenopausal women with stress ...

4. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/18821291/

The effect of testosterone therapy on lower urinary tract ... This study suggests that in addition to improvement in sexual functions, testosterone therapy may also improve LUTS/bladder functions by increasing bladder ...

5. rally.massgeneralbrigham.org rally.massgeneralbrigham.org/study/testosterone_incontinence

Testosterone Therapy To Improve Pelvic Floor Muscles in ... Testosterone may help improve pelvic floor muscles and provide a treatment option for women with stress urinary incontinence.

6. sciencedirect.com sciencedirect.com/science/article/pii/S1110570412000422

Practical Aspects of Testosterone Deficiency Syndrome in ... Stress urinary incontinence (SUI) in the male is most commonly seen post-prostatectomy 18, 19. It is always linked to deficient external sphincter muscles; ...

7. journals.lww.com journals.lww.com/juop/fulltext/2023/09000/male_hypogonadism_does_not_affect_surgical.3.aspx

Male Hypogonadism Does Not Affect Surgical Outcomes ... Studies suggest a link between hypogonadism and complications after artificial urinary sphincter (AUS) placement.

8. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37906265/

Correlation of serum circulating testosterone levels with ... The results of the present study indicate that low levels of serum testosterone are associated with an increased likelihood of stress urinary incontinence in ...