RECRUITING

The Anabolic Effect of Testosterone on Pelvic Floor Muscles

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

Stress urinary incontinence is the most common female pelvic floor disorder encountered in clinical practice with significant negative impact on quality of life. The prevalence of urinary incontinence increases with aging, and weakness of the pelvic floor muscles contributes to the development of stress urinary incontinence. Given that androgen receptors are expressed throughout the pelvic floor, the anabolic effects of androgens on pelvic floor muscles may provide a therapeutic option in women with stress urinary incontinence. The investigators are conducting a randomized, double-blind, placebo-controlled proof-of-concept trial in older postmenopausal women with stress urinary incontinence to assess whether testosterone therapy can increase pelvic floor muscles and improve urinary function.

Official Title

A Pilot Study to Evaluate the Anabolic Effect of Testosterone on Muscles of the Pelvic Floor in Older Women With Stress Urinary Incontinence

Quick Facts

Study Start:2025-02-15
Study Completion:2026-05-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06111209

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:60 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Women, age 60 years and older.
  2. * Medically documented pure stress urinary incontinence on physical exam or urodynamic testing.
  3. * Normal mammogram within the last 12 months
  4. * Endometrial thickness of ≤4 mm in women with an intact uterus assessed by endometrial ultrasound.
  5. * Ability and willingness to provide informed consent.
  1. * • Medically documented urge or mixed urinary incontinence (stress and urge) on physical exam or urodynamic testing.
  2. * Participating in pelvic floor muscle training (PFMT) therapy currently or in the past 3 months
  3. * 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.
  4. * History of ≥ Grade 3 pelvic organ prolapse
  5. * Neurologic disorder causing UI or bladder dysfunction (i.e., multiple sclerosis, Parkinson's disease, stroke, cerebral palsy, spinal cord injury)
  6. * Current urinary tract infection
  7. * History of breast or endometrial cancer
  8. * Use of systemic estrogen therapy in the past 3 months
  9. * Baseline hematocrit \>48%, serum creatinine \>2.5 mg/dL; HbA1c \>8.0%; BMI \>40 kg/m2
  10. * Uncontrolled hypertension defined as an average of two blood pressure readings of greater than 160/100.
  11. * Subjects who are on insulin therapy will be excluded.
  12. * Uncontrolled congestive heart failure
  13. * Myocardial infarction, acute coronary syndrome, revascularization surgery or stroke within 6 months
  14. * History of pulmonary embolism, deep vein thrombosis or a genetic thromboembolic disorder
  15. * History of bipolar disorder, schizophrenia or untreated major depression
  16. * Presence of metallic implants (pacemakers, aneurysm clips, etc.) that preclude the patient from undergoing MRI

Contacts and Locations

Study Contact

Shalender Bhasin, MB,BS
CONTACT
617-525-9150
sbhasin@bwh.harvard.edu

Principal Investigator

Grace Huang, MD
PRINCIPAL_INVESTIGATOR
Brigham and Women's Hospital

Study Locations (Sites)

Brigham and Women's Hospital
Boston, Massachusetts, 02115
United States

Collaborators and Investigators

Sponsor: Brigham and Women's Hospital

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-02-15
Study Completion Date2026-05-31

Study Record Updates

Study Start Date2025-02-15
Study Completion Date2026-05-31

Terms related to this study

Keywords Provided by Researchers

  • stress urinary incontinence
  • testosterone therapy
  • menopause
  • pelvic floor disorders

Additional Relevant MeSH Terms

  • Stress Urinary Incontinence
  • Menopause