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Testosterone for Stress Urinary Incontinence in Older Women

This study is looking at whether testosterone cypionate can help older women (age 60 and above) with stress urinary incontinence (leaking urine when you cough, sneeze, or exercise). Researchers believe that testosterone might strengthen pelvic floor muscles, which are important for bladder control. You might be able to join if you are a woman aged 60 or older with stress urinary incontinence, have had a normal mammogram recently, and meet other health criteria. The main goal is to see if testosterone cypionate increases the volume of your pelvic floor muscles after 12 weeks. The study is currently recruiting participants.

Study design
This is a 12-week, double-blind, randomized, placebo-controlled study with 30 participants. This means some participants will receive testosterone cypionate and others a placebo (inactive substance), but neither you nor the researchers will know which you are receiving.
What's involved
You would receive weekly intramuscular injections of either testosterone cypionate or placebo for 12 weeks. You would also have an MRI to measure pelvic floor muscle volume and undergo urodynamic testing to assess bladder function.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint is measured at 12 weeks, which suggests the main treatment period and evaluation conclude around this time.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06111209

The Anabolic Effect of Testosterone on Pelvic Floor Muscles

Active, Not Recruiting
PHASE2Ages 60+InterventionalTreatment
Brigham and Women's Hospital
~30 participants
Updated 2026-06-26 on ClinicalTrials.gov
What's tested:Testosterone cypionatePlacebo

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in pelvic floor muscle volume
Measured over 12 weeks

Conditions

Stress Urinary Incontinence
Menopause

Explore related trials

Genuine stress incontinenceMenopause present

Where it's being run

1 sites across 1 states
Massachusetts1

Study leadership

  • Grace Huang, MD · PRINCIPAL_INVESTIGATOR · Brigham and Women's Hospital

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Women, age 60 years and older.
Medically documented pure stress urinary incontinence on physical exam or urodynamic testing.
Normal mammogram within the last 12 months
Endometrial thickness of ≤4 mm in women with an intact uterus assessed by endometrial ultrasound.
Ability and willingness to provide informed consent.

Exclusion

• Medically documented urge or mixed urinary incontinence (stress and urge) on physical exam or urodynamic testing.
Participating in pelvic floor muscle training (PFMT) therapy currently or in the past 3 months
Previous pelvic surgery (i.e., hysterectomy, pelvic organ prolapse repair, mid-urethral sling placement, injection of urethral bulking agents) or radiation treatment to the pelvis.
History of ≥ Grade 3 pelvic organ prolapse
Neurologic disorder causing UI or bladder dysfunction (i.e., multiple sclerosis, Parkinson's disease, stroke, cerebral palsy, spinal cord injury)
Current urinary tract infection
History of breast or endometrial cancer
Use of systemic estrogen therapy in the past 3 months
Baseline hematocrit \>48%, serum creatinine \>2.5 mg/dL; HbA1c \>8.0%; BMI \>40 kg/m2
Uncontrolled hypertension defined as an average of two blood pressure readings of greater than 160/100.
Subjects who are on insulin therapy will be excluded.
Uncontrolled congestive heart failure
Myocardial infarction, acute coronary syndrome, revascularization surgery or stroke within 6 months
History of pulmonary embolism, deep vein thrombosis or a genetic thromboembolic disorder
History of bipolar disorder, schizophrenia or untreated major depression
Presence of metallic implants (pacemakers, aneurysm clips, etc.) that preclude the patient from undergoing MRI

What this trial measures

  • Change in pelvic floor muscle volume12 weeks

    volume of levator ani muscles of the pelvic floor, assessed by magnetic resonance imaging (MRI)