Stress Urinary IncontinenceNCT03116087
Testosterone Replacement in Postmenopausal Women With Stress Urinary Incontinence
A study testing Testosterone patch in people with Stress Urinary Incontinence, run by Charles Drew University of Medicine and Science at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 45 to 75 years, women only
- Conditions the study is for
- Stress Urinary Incontinence
- What is being tested?
- Testosterone patch
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2007to 31 May 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Charles R. Drew University of Medicine and Science
Los Angeles, California, 90059
About this study
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.
Read the 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.
- Conditions
- Stress Urinary Incontinence
- Being tested
- Testosterone patch, Placebo
- Keywords
- Postmenopausal women
- Medical subject headings
- Urinary Incontinence, Stress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Testosterone patchDrug
Also called Testosterone patches
300 mcg testosterone patches or placebo applied twice weekly
PlaceboDrug
Also called Placebo patch
Placebo patch
| Study group | Role | What they receive |
|---|---|---|
| Testosterone patch | Active comparator | Testosterone patches Receives: Drug: Testosterone patch |
| Placebo | Placebo comparator | Placebo patches Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 36 weeks
Secondary outcomes (6)
Change in urethral pressure profile.
This outcome will be evaluated with urodynamic measurement of urethral pressure (in cm H2O) along the urethra.
Measured: 36 weeks
Change in pelvic floor muscle strength.
This outcome will be measured with a perineometer.
Measured: 36 weeks
Change in amounts of urinary leakage.
This will be measured with the Pad Test ( in a 24 hour period).
Measured: 36 weeks
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.
Measured: 36 weeks
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.
Measured: 36 weeks
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.
Measured: 36 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2017
- Study start1 Mar 2007
- Primary completion31 May 2018
- Study completion31 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stress Urinary IncontinenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Charles Drew University of Medicine and Science
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Matthew Ho, Charles Drew University of Medicine and Science
- Investigators
- Matthew H Ho, MD, Principal investigator, Charles R. Drew University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03116087
- Sponsor's protocol ID
- 5-U54-HD041748-03-D227F
- Other IDs
- 5U54HD041748-03
- Status last verified
- Aug 2018
- First submitted
- 4 Mar 2012
- Last updated
- 9 Aug 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: Plan to share IPD: Presentation (grand rounds, scientific meetings) and peer-reviewed publications.
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Testosterone Replacement in Postmenopausal Women With Stress Urinary Incontinence
- ClinicalTrials.gov ID
- NCT03116087
- Acronym / sponsor ID
- 5-U54-HD041748-03-D227F
- Conditions
- Stress Urinary Incontinence
- Keywords
- Postmenopausal women
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Charles Drew University of Medicine and ScienceUniversity, hospital or other
- Study start
- 1 Mar 2007 (actual)
- Primary completion
- 31 May 2018 (actual)
- Study completion
- 31 May 2018 (actual)
- First posted
- 14 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Testosterone patch | Active comparator | Drug: Testosterone patchTestosterone patches |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo patches |
Who may qualify
- Ages
- 45 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
Key exclusion criteria (16 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Testosterone patchAlso: Testosterone patches300 mcg testosterone patches or placebo applied twice weekly | Drug | Testosterone patch |
| PlaceboAlso: Placebo patchPlacebo patch | Drug | Placebo |
Primary outcome
Our primary outcome measure is the change in levator ani muscle volume with correlation in improvement in stress incontinence.
Time frame: 36 weeks
This outcome will be assessed by MRI, urodynamic studies and pad tests.
6 secondary outcomes
Change in urethral pressure profile.
Time frame: 36 weeks
Change in pelvic floor muscle strength.
Time frame: 36 weeks
Change in amounts of urinary leakage.
Time frame: 36 weeks
Change in subjective quality of life as it relates to incontinence.
Time frame: 36 weeks
Change in hormone levels including total and free testosterone, dihydrotestosterone (DHT), estradiol 17 B, sex hormone binding globulin (SHBG).
Time frame: 36 weeks
Change in laboratory values.
Time frame: 36 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2018.
- Individual participant dataSharing planned: Yes. Plan to share IPD: Presentation (grand rounds, scientific meetings) and peer-reviewed publications.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Matthew H Ho, MD principal investigator
Charles R. Drew University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Testosterone patch in people with Stress Urinary Incontinence, run by Charles Drew University of Medicine and Science at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Our primary outcome measure is the change in levator ani muscle volume with correlation in improvement in stress incontinence. (time frame: 36 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Aug 2018.