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Testosterone Replacement in Postmenopausal Women With Stress Urinary Incontinence

Primary Purpose

Stress Urinary Incontinence

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Testosterone patch
Placebo
Sponsored by
Charles Drew University of Medicine and Science
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stress Urinary Incontinence focused on measuring Postmenopausal women

Eligibility Criteria

45 Years - 75 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Inclusion Criteria:

    • 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.

Exclusion Criteria:

  • 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.
  • Subjects who cannot have an MRI due to metal implants or pacemaker.

Sites / Locations

  • Charles R. Drew University of Medicine and Science

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Testosterone patch

Placebo

Arm Description

Testosterone patches

Placebo patches

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Change in urethral pressure profile.
This outcome will be evaluated with urodynamic measurement of urethral pressure (in cm H2O) along the urethra.
Change in pelvic floor muscle strength.
This outcome will be measured with a perineometer.
Change in amounts of urinary leakage.
This will be measured with the Pad Test ( in a 24 hour period).
Change in subjective quality of life as it relates to incontinence.
This outcome will be measured with a validated questionnaire and compared with the baseline before treatment.
Change in hormone levels including total and free testosterone, dihydrotestosterone (DHT), estradiol 17 B, sex hormone binding globulin (SHBG).
These will be measured at the baseline (before treatment) and then every four weeks during the treatment and recovery periods and compared with the baseline.
Change in laboratory values.
The blood sample will be collected for laboratory measurement (CBC, chem 20, lipid profile) at the baseline (before treatment) and then every four weeks during the treatment and recovery periods and compared with the baseline.

Full Information

First Posted
March 4, 2012
Last Updated
August 8, 2018
Sponsor
Charles Drew University of Medicine and Science
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1. Study Identification

Unique Protocol Identification Number
NCT03116087
Brief Title
Testosterone Replacement in Postmenopausal Women With Stress Urinary Incontinence
Official Title
Testosterone Replacement in Postmenopausal Women With Stress Urinary Incontinence
Study Type
Interventional

2. Study Status

Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
March 1, 2007 (Actual)
Primary Completion Date
May 31, 2018 (Actual)
Study Completion Date
May 31, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Charles Drew University of Medicine and Science

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
Primary Outcome Measure: Our primary outcome measure is the change in levator ani muscle volume with correlation in improvement in stress incontinence. These will be assessed by MRI, urodynamic studies and pad tests. [Time Frame: 36 weeks] Secondary Outcome Measures: Our secondary outcome measures are: [Time Frame: 36 weeks] Change in urodynamic measurements including urethral pressure profile, cough stress profile, maximum urethral closure pressure, Valsalva leak point pressure, and pressure transmission ratios. Change in pelvic floor muscle strength as measured with a perineometer. Change in amounts of urinary leakage (in a 24 hour period) using the Pad Test. Change in subjective quality of life as it relates to incontinence using the Incontinence Impact Questionnaire, Urogenital Distress Inventory and Incontinence Diary. Change in hormone levels including total and free testosterone, dihydrotestosterone (DHT), estradiol 17 B, and sex hormone binding globulin (SHBG). Change in complete blood count, chem 20, lipid profile (total cholesterol, triglyceride, HDL, LDL) and physical examination as compared to the baseline before treatment.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stress Urinary Incontinence
Keywords
Postmenopausal women

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Testosterone patch
Arm Type
Active Comparator
Arm Description
Testosterone patches
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo patches
Intervention Type
Drug
Intervention Name(s)
Testosterone patch
Other Intervention Name(s)
Testosterone patches
Intervention Description
300 mcg testosterone patches or placebo applied twice weekly
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
Placebo patch
Intervention Description
Placebo patch
Primary Outcome Measure Information:
Title
Our primary outcome measure is the change in levator ani muscle volume with correlation in improvement in stress incontinence.
Description
This outcome will be assessed by MRI, urodynamic studies and pad tests.
Time Frame
36 weeks
Secondary Outcome Measure Information:
Title
Change in urethral pressure profile.
Description
This outcome will be evaluated with urodynamic measurement of urethral pressure (in cm H2O) along the urethra.
Time Frame
36 weeks
Title
Change in pelvic floor muscle strength.
Description
This outcome will be measured with a perineometer.
Time Frame
36 weeks
Title
Change in amounts of urinary leakage.
Description
This will be measured with the Pad Test ( in a 24 hour period).
Time Frame
36 weeks
Title
Change in subjective quality of life as it relates to incontinence.
Description
This outcome will be measured with a validated questionnaire and compared with the baseline before treatment.
Time Frame
36 weeks
Title
Change in hormone levels including total and free testosterone, dihydrotestosterone (DHT), estradiol 17 B, sex hormone binding globulin (SHBG).
Description
These will be measured at the baseline (before treatment) and then every four weeks during the treatment and recovery periods and compared with the baseline.
Time Frame
36 weeks
Title
Change in laboratory values.
Description
The blood sample will be collected for laboratory measurement (CBC, chem 20, lipid profile) at the baseline (before treatment) and then every four weeks during the treatment and recovery periods and compared with the baseline.
Time Frame
36 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Inclusion Criteria: 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. Exclusion Criteria: 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. Subjects who cannot have an MRI due to metal implants or pacemaker.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Matthew H Ho, MD
Organizational Affiliation
Charles R. Drew University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Charles R. Drew University of Medicine and Science
City
Los Angeles
State/Province
California
ZIP/Postal Code
90059
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Plan to share IPD: Presentation (grand rounds, scientific meetings) and peer-reviewed publications.

Learn more about this trial

Testosterone Replacement in Postmenopausal Women With Stress Urinary Incontinence

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