Multiple Sclerosis, Neurogenic Bladder
Conditions
Keywords
remyelination, urogenital health, multiple sclerosis
Brief summary
Study to evaluate the efficiency of vaginal estriol, as a treatment for urogenital symptoms in female patients with RRMS. The secondary objective is to evaluate the potential role of vaginal estriol in re-myelination in RRMS patients.
Detailed description
Pilot project to determine the effectiveness of 1 mg transvaginal estriol, as an adjunctive therapy for female MS patients. The goal is to recruit 20 patients from the MS clinic in the neurology department of Texas Tech University Health Sciences Center. This study has been planned in collaboration with reproductive endocrinology, endocrinology, gynecology and basic science. The 1mg transvaginal dose was chosen after careful search of the literature and consultation with collaborators. Single-group pilot study. Subjects: Patients with relapsing remitting MS and urogenital symptoms (frequency, urgency, frequent urinary tract infections, incontinence) will be invited to participate in the study. Enrollment will be during their scheduled clinic appointment. Some candidates (patients of the primary investigator) may be contacted by phone and invited to participate in the study. The clinical trial will be explained to potential participants in detail, reviewing the objectives and methodology of the study. There will be adequate time allotted to answer any questions or concerns from the potential participants. Those patients interested in participating in the study will be asked to sign the consent form. In order to remind patients about their follow-up visits, lab work, etc., they will be contacted routinely. Participants will be instructed to call in case of questions or concerns. Patients will be evaluated clinically during their scheduled follow up in which a full neurological exam will be performed during each visit. Patients will be instructed by the primary investigator how to correctly use the vaginal cream. This will be done at their enrolment and reinforced by the principal investigator, during their follow up visits.
Interventions
DRUGvaginal estriol
Estriol vaginal cream will be formulated by Twin Oaks specialty pharmacy-by the same compound specialist. 30 mg estriol powder will be mixed with 5 mL of propylene glycol and 22 g of vaginal base cream. The product can be stored at room temperature and has a shelf life of up to 4 months. It comes with an applicator.
Sponsors
Texas Tech University Health Sciences Center
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
This is a single-group prospective repeated-measures pilot trial. Duration is 12 months,
Eligibility
Sex/Gender
FEMALE
Age
40 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
1. Female patients with RRMS over the age of 40 to 65. * Being prescribed vaginal estriol to treat their urogenital symptoms such as frequency, urgency, incontinence and frequent urinary tract infections. * Patients that had underwent chemical or surgical hysterectomy. 2. Patients will continue their current disease modifying agent for MS during the trial.
Exclusion criteria
1. Patients with history of breast cancer, uterine or ovarian cancer. 2. Patients with progressive multiple sclerosis 3. Patients who are unable to undergo an MRI 4. Males 5. Patient is already on vaginal or oral or transdermal estrogens 6. Pregnant or breast-feeding patients 7. Patient taking sex hormones eg testosterone for libido 8. Patients taking DHEA or OTC related products that could influence the hormonal milieu. 9. Patient with prolapse uterus or conditions that would impact on transvaginal absorption of estriol
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Bladder Control Scale (BLCS) | baseline and 9 months | The questions are regarding control of the bladder, number of accidents in the past 4 weeks, alteration of activities because of bladder problems and restriction on lifestyle because of bladder problems. The total score for the BLCS is the sum of the scores for the 4 items. Scores can range from 0-22, with higher scores indicating greater bladder control problems. Change from baseline at 9 months. |
| Change in Visual Evoked Potential and Ocular Tomography Results From Baseline to 9 Months of Both Eyes | Baseline and 9 months | visual evoked potential measured in each eye at baseline and 9 months normal value should be bellow 100 milliseconds |
| Change in MS Quality of Life Questionnaire at Baseline and 9 Months. (Physical Score) | Quality of life score at baseline and Quality of life score at 9 months | Multiple sclerosis quality of life questionnaire is an extensive questionnaire filled by the patient and graded by physician. It consists of 2 main areas the physical health which include physical function, health perceptions, energy fatigue, role limitations, pain, sexual function, social function and health distress. The mental health score which includes health distress, overall quality of life, emotional wellbeing, role limitations and cognitive function. The physical health and mental health parts each include a possible score range of 0-100. Overall the lower the score the better |
Countries
United States
Participant flow
Pre-assignment details
one participant was enrolled twice
Participants by arm
| Arm | Count |
|---|---|
| Vaginal Estriol as a Potential Adjunctive Therapy for MS Remyelination To evaluate the efficiency of vaginal estriol, as a treatment for urogenital symptoms in female patients with RRMS.
vaginal estriol: Estriol vaginal cream will be formulated by Twin Oaks specialty pharmacy-by the same compound specialist. 30 mg estriol powder will be mixed with 5 mL of propylene glycol and 22 g of vaginal base cream. The product can be stored at room temperature and has a shelf life of up to 4 months. It comes with an applicator. | 12 |
| Total | 12 |
Baseline characteristics
| Characteristic | Vaginal Estriol as a Potential Adjunctive Therapy for MS Remyelination | — |
|---|---|---|
| Age, Categorical <=18 years | 0 Participants | — |
| Age, Categorical >=65 years | 0 Participants | — |
| Age, Categorical Between 18 and 65 years | 12 Participants | — |
| Age, Continuous | 52 years STANDARD_DEVIATION 6.9 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment United States | 12 Participants | — |
| Sex: Female, Male Female | 12 Participants | — |
| Sex: Female, Male Male | 0 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 12 |
| other Total, other adverse events | 0 / 12 |
| serious Total, serious adverse events | 0 / 12 |
Outcome results
Primary
Change in Bladder Control Scale (BLCS)
The questions are regarding control of the bladder, number of accidents in the past 4 weeks, alteration of activities because of bladder problems and restriction on lifestyle because of bladder problems. The total score for the BLCS is the sum of the scores for the 4 items. Scores can range from 0-22, with higher scores indicating greater bladder control problems. Change from baseline at 9 months.
Time frame: baseline and 9 months
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Urogenital Symptoms | Change in Bladder Control Scale (BLCS) | -9 score on a scale |
p-value: 0.002p value
Primary
Change in MS Quality of Life Questionnaire at Baseline and 9 Months. (Physical Score)
Multiple sclerosis quality of life questionnaire is an extensive questionnaire filled by the patient and graded by physician. It consists of 2 main areas the physical health which include physical function, health perceptions, energy fatigue, role limitations, pain, sexual function, social function and health distress. The mental health score which includes health distress, overall quality of life, emotional wellbeing, role limitations and cognitive function. The physical health and mental health parts each include a possible score range of 0-100. Overall the lower the score the better
Time frame: Quality of life score at baseline and Quality of life score at 9 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Urogenital Symptoms | Change in MS Quality of Life Questionnaire at Baseline and 9 Months. (Physical Score) | Quality of life Physical score | 14.87 score on a scale | Standard Deviation 16.9 |
| Urogenital Symptoms | Change in MS Quality of Life Questionnaire at Baseline and 9 Months. (Physical Score) | Quality of life Mental score | 10.8 score on a scale | Standard Deviation 17.8 |
Primary
Change in Visual Evoked Potential and Ocular Tomography Results From Baseline to 9 Months of Both Eyes
visual evoked potential measured in each eye at baseline and 9 months normal value should be bellow 100 milliseconds
Time frame: Baseline and 9 months
Population: patients were evaluated at baseline and 9 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Urogenital Symptoms | Change in Visual Evoked Potential and Ocular Tomography Results From Baseline to 9 Months of Both Eyes | R EYE | -4.4 millisecond | Standard Deviation 10.4 |
| Urogenital Symptoms | Change in Visual Evoked Potential and Ocular Tomography Results From Baseline to 9 Months of Both Eyes | L EYE | -10.7 millisecond | Standard Deviation 14.4 |