Testosterone Replacement in Postmenopausal Women With Stress Urinary Incontinence

NCT03116087 | Completed DMC

• 2 other identifiers: 5-U54-HD041748-03-D227F5U54HD041748-03
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The overall objective of this study is to establish if testosterone replacement in post-menopausal women with low testosterone levels and stress urinary incontinence (SUI) will lead to improvement in symptoms of SUI. This study is a prospective, randomized, double-blind, placebo-controlled, parallel-group, clinical trial and will involve sixty (60) post-menopausal women with clinically diagnosed stress urinary incontinence and low testosterone concentrations. These subjects will enter the control period, which involves the baseline measurements of pelvic floor muscle volume and strength, amounts of urine leakage in 24-hour period, urodynamic parameters, and quality of life using Incontinence Impact Questionnaire and Urogenital Distress Inventory. Subjects are then randomly assigned to either placebo (30 subjects) or 300 mcg/twice-weekly testosterone patch (30 subjects) group. Both the subjects and investigators will be blinded. The duration of the testosterone/control study will be 36 weeks, with weeks 1-3 screening/control period, 4-28 application of placebo or testosterone patches and 29-36 recovery time/assessment of effects.

Conditions

Stress Urinary Incontinence

Keywords

Postmenopausal women

Outcome Measures

Primary Outcomes (1)

• Our primary outcome measure is the change in levator ani muscle volume with correlation in improvement in stress incontinence.

  This outcome will be assessed by MRI, urodynamic studies and pad tests.

  36 weeks

Secondary Outcomes (6)

• Change in urethral pressure profile.

  36 weeks

• Change in pelvic floor muscle strength.

  36 weeks

• Change in amounts of urinary leakage.

  36 weeks

• Change in subjective quality of life as it relates to incontinence.

  36 weeks

• Change in hormone levels including total and free testosterone, dihydrotestosterone (DHT), estradiol 17 B, sex hormone binding globulin (SHBG).

  36 weeks

Study Arms (2)

Testosterone patch

ACTIVE COMPARATOR

Testosterone patches

Drug: Testosterone patch

Placebo

PLACEBO COMPARATOR

Placebo patches

Drug: Placebo

Interventions

Testosterone patch DRUG

300 mcg testosterone patches or placebo applied twice weekly

Also known as: Testosterone patches

Testosterone patch

Placebo DRUG

Placebo patch

Also known as: Placebo patch

Placebo

Eligibility Criteria

• Age: 45 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Ambulatory, postmenopausal women
• The presence of stress urinary incontinence, defined as involuntary urine loss during physical activity, cough, or sneeze.
• Able to understand and give informed consent.
• Those on estrogen replacement therapy prior to the study should have been on a stable regimen for at least three months. For those who are not on estrogen replacement therapy prior to the study, will not be started on estrogen for the duration of the study.
• Normal Pap smear and mammogram in the preceding 12 months by history and chart review.

You may not qualify if:

• Uncontrolled depression as assessed by history and physical exam.
• Those with any acute or chronic illness, malignant disease, fever of known or unknown origin, diabetes mellitus (fasting blood glucose \> 126 mg/dl), or uncontrolled hypertension (defined as blood pressure greater than 160/100).
• Current urinary tract infection (UTI). For those with acute UTI, treatment will be given and repeat culture should be negative before enrollment.
• Severe obesity defined as body mass index of greater than 40 kg/m2.
• Current or recent (last 6 months) use of illicit drugs (which may affect appetite, food intake, metabolism, and/or compliance with the protocol).
• Current or recent (last 6 months) alcohol or drug dependence.
• Significant liver function abnormalities defined as AST, ALT, or alkaline phosphatase value of greater than three times the upper limit of normal in our Clinical Pathology Laboratory, or serum bilirubin levels of greater than 2 mg/dl.
• History of breast or endometrial cancer.
• History of hyperandrogenic disorders such as hirsutism and polycystic ovary disease.
• Previous intolerance to testosterone.
• Women with abnormal PAP smears or mammograms will be included only after they have been evaluated by their gynecologists and breast and uterine/cervical cancers have been excluded by appropriate diagnostic tests.
• Women with significant dementia as assessed by history and physical exam.
• Those with disabilities that would prevent them from participating in the outcome testing, including tests of pelvic floor strength (e.g. severe arthritis, Parkinson's disease, stroke, or myopathy).
• Those who have received in the preceding three months drugs known to affect testosterone production or metabolism such as Ketoconazole, Megace, and or anabolic/androgenic steroids.
• Because of their age and post-menopausal status, spontaneous pregnancy is unlikely. Regardless, women who are pregnant, seeking to become pregnant in the next six months, or breastfeeding will not be included.

Sponsors & Collaborators

• Charles Drew University of Medicine and Science: lead

Study Sites (1)

Charles R. Drew University of Medicine and Science

Los Angeles, California, 90059, United States

Location

MeSH Terms

Conditions

Urinary Incontinence, Stress

Condition Hierarchy (Ancestors)

Urinary Incontinence; Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Matthew H Ho, MD

  Charles R. Drew University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: March 4, 2012
• First Posted: April 14, 2017
• Study Start: March 1, 2007
• Primary Completion: May 31, 2018
• Study Completion: May 31, 2018
• Last Updated: August 9, 2018

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will share

Locations

US (1)