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This is a prospective observational study of women undergoing vaginal treatment with the fractional carbon dioxide (fCO2) laser for various urogenital symptoms.
Fractional carbon dioxide (fCO2) laser treatment of the vaginal tissue has been proposed as a treatment for various genitourinary symptoms, including vaginal itching, burning, dryness, dyspareunia (difficult or painful sexual intercourse), dysuria (painful or difficult urination), nocturia (waking at night to urinate), incontinence (the involuntary loss of urine), urine frequency, urine urgency, and urinary tract infection (UTI).
Case report and case series data suggest that laser treatment of the vaginal tissues is well tolerated by patients and does not pose serious risks to the patient. Several case series demonstrate improvements in vulvovaginal and urinary symptoms, and in sexual function. However, these studies are from a select few centers, are small, and are also biased in that the laser treatment is only available to patients who are able to pay for it. Additionally, most studies report only on vulvovaginal symptoms, despite increasing use of laser for urinary symptoms. Several recent editorials have called for larger studies with longer follow-up and high quality outcome measures. This study has been designed to address these needs.
This is a prospective observational study of women undergoing vaginal treatment with the fCO2 laser for a wide range of patients with vulvovaginal, sexual and/or urologic complaints. The effects of fCO2 therapy will be evaluated by various physical assessments and patient questionnaires.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| fCO2 Laser Therapy Group | Women treated with the fCO2 laser |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| fCO2 Laser Therapy Group | Device | Women enrolled in the study will receive three treatments with the fractional carbon dioxide (fCO2) laser. The interval between treatments is approximately six weeks. Intra-vaginal laser treatments will be delivered at 8 points at each level of the vaginal wall. |
| Measure | Description | Time Frame |
|---|---|---|
| Patient Global Impression of Improvement (PGI-I) Score at 4 Weeks After Initial Treatment | PGI-I score is recorded 4 weeks after initial treatment completion. The PGI-I asks the patient to "check the box that best describes how your urinary and/or vaginal symptoms are now, compared with how you symptoms were before you began this study." There are 7 possible responses ranging from 1 to 7, where 1 is "Very Much Better", 2 is "Much Better, 3 is "A Little Bit Better", 4 is "No Change", 5 is "A Little Worse", 6 is "Much Worse", and 7 is "Very Much Worse". A score from 1 to 3 would indicate improvement. | 4 weeks post-initial treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Patient Global Impression of Improvement (PGI-I) Score | The average change in patients' PGI-I scores from baseline to 6 months and 36 months post-treatment. The PGI-I asks the patient to "check the one number that best describes how your urinary tract condition is now compared with how it was before your treatment." There are 7 possible responses ranging from 1 to 7, where 1 is "Very Much Better" and 7 is "Very Much Worse". A lower score would represent improvement and a favorable outcome. |
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Inclusion Criteria:
Female
18 years of age or greater and 90 years of age or less
One or more of the following indications for fCO2 laser treatment:
Must sign the informed consent
Must be willing to comply with the study protocol
Exclusion Criteria:
Contraindications to fCO2 laser treatment, such as:
Patients who have received vaginal fCO2 laser treatment within the past 12 months
Patients treated with vaginal estrogen within the past 3 months
Patients with undiagnosed vaginal bleeding
Active vulvar or vaginal infection, including herpes, candidiasis, etc.
Current urinary tract infection (UTI), confirmed by positive urine culture and patient-reported symptoms
Pelvic or vaginal surgery with the past 9 months
Pelvic organ prolapse beyond the introitus
Patient possesses any other characteristics that, per the investigator's judgment, deems them unsuitable (i.e. may increase the patient's risk, may affect the conduct of the study etc.) for the treatment and/or study
Participation in an investigational trial that used a study treatment, medication and/or biologic within 6 months or less prior to the date of the screening visit
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Women meeting all of the inclusion criteria and non of the exclusion criteria may be enrolled in the study.
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| Name | Affiliation | Role |
|---|---|---|
| Kenneth Peters, MD | Corewell Health William Beaumont University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Corewell Health William Beaumont University Hospital | Royal Oak | Michigan | 48073 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | fCO2 Laser Therapy Group | Women treated with the fCO2 laser fCO2 Laser Therapy Group: Women enrolled in the study will receive three treatments with the fractional carbon dioxide (fCO2) laser. The interval between treatments is approximately six weeks. Intra-vaginal laser treatments will be delivered at 8 points at each level of the vaginal wall. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 3, 2022 |
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|
| 6 months and 36 months post-initial treatment |
| Change in Vaginal pH and Overall Vaginal Health on Physical Exam as Measured by the Vaginal Health Inventory Score (VHIS). | The Vaginal Health Inventory Score (VHIS) is an assessment tool, used by providers, to determine if vaginal atrophy is present. Providers perform a vaginal exam and give a score of 1-5 (abnormal to normal, respectively) on each of the following vaginal parameters: elasticity, secretion/fluid volume, vaginal pH, integrity of the epithelium, and lubrication/moisture of the vaginal wall. A VHIS score less than 15 is indicative of vaginal atrophy. | 6 months and 36 months post-initial treatment |
| Change in Urinary Symptoms as Measured by the Questionnaire for Urinary Incontinence Diagnosis (QUID). | Patients will complete the QUID, which consists of 6 questions. Responses to the questions indicate the frequency of urinary incontinence. Scores are: 0 (none of the time), 1 (rarely), 2 (once in awhile), 3 (often), 4 (most of the time), or 5 (all of the time). Responses to items 1, 2, and 3 are summed for the Stress Urinary Incontinence Score. Responses to items 4, 5, and 6 are summed for the Urge Incontinence Score. | 6 months and 36 months post-initial treatment |
| Change in Overactive Bladder (OAB) Symptoms as Measured by the Overactive Bladder Questionnaire-Short Form (OAB-q SF). | The OAB-q SF consists of two scales assessing symptom bother and health-related quality of life (HR-QOL) in patients with OAB. Each question is rated on a 6 point scale with 1 = Not at all and 6 = A very great deal. | 6 months and 36 months post-initial treatment |
| Change in Voiding Diaries. | A 3-day voiding diary will be completed by the patient and evaluated to describe urinary frequency and incontinence episodes. | 6 months and 36 months post-initial treatment |
| Change in Sexual Function, Including Dyspareunia Symptoms, as Measured by the Female Sexual Function Inventory (FSFI). | The FSFI consists of 6 subscales related to sexual desire (2 Qs scale 1 worst - 5 best), arousal (4Qs 0 worst - 5 best), lubrication (4Qs 0 worst-5 best), orgasm (3Qs 0 worst - 5 best), satisfaction ( 3Qs 0 worst - 5 best), and pain (3 Qs 0 worst - 5 best). Higher scores indicate higher sexual functioning. Scores range from 2-36. A score of 26.55 has been clinically selected as the cut-off for sexual dysfunction. Scores below this value indicate sexual dysfunction. | 6 months and 36 months post-initial treatment |
| Change in Frequency of UTI Occurrences, as Measured by a Positive Urine Culture Test. | A clean catch urine specimen will be collected at each visit. A positive urine dipstick test will have the presence of leukocytes and nitrites accompanied by symptoms (dysuria, bladder pain, and/or urinary frequency). | 6 months and 36 months post-initial treatment |
| Change in Mental Health Status as Measured by the Generalized Anxiety Disorder Questionnaire (GAD-7). | The GAD-7 is a self-reported questionnaire for screening and measuring severity of generalized anxiety disorder. There are 7 questions total, each answer is scored on a scale from 0 = not at all to 3 = nearly every day. Scores greater than or equal to 10 indicate moderate anxiety and further assessment is recommended. | 6 months and 36 months post-initial treatment |
| Change in Mental Health Status as Measured by the Patient Health Questionnaire (PHQ-8). | The PHQ-8 is an eight item questionnaire that is a valid diagnostic and severity measure for depressive disorders. Each question is scored from 0 = not at all to 3 = nearly every day. A score of 10 or greater is considered major depression and a score of 20 or more as severe major depression. | 6 months and 36 months post-initial treatment |
| Change in Life and Sexual Impact of Vulvovaginal Skin Symptoms. | The Incontinence Quality of Life Questionnaire (I-QOL) is a validated tool to assess the impact of urinary incontinence problems. The I-QOL has 22 incontinent-specific quality of life items all having the following five-point ordinal response scale: 1= Extremely, 2= Quite a Bit, 3= Moderately, 4= A Little, and 5= Not at All. Total I-QOL is a combined score of all items. All 22 items are summed to calculate a total I-QOL score, ranging from 22 to 110, with a high score indicating a better quality of life. The 22 items are broken down into 3 subscales: Avoidance and Limiting Behaviors Score (8 of the 22 items), Psychosocial Impacts Score (9 of the 22 items), and Social Embarrassment Score (5 of the 22 items). Scores are summed based on the same 5-point scale. 1= Extremely, 2= Quite a Bit, 3= Moderately, 4= A Little, and 5= Not at All. A high score indicates a better quality of life. | 6 months and 36 months post-initial treatment |
| Change in the Presence of Lactobacillus, Assessed by Vaginal Swab. | Presence or absence of lactobacillus will be collected by the physician via a vaginal swab and assessed under the microscope. | 6 months and 36 months post-initial treatment |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | fCO2 Laser Therapy Group | Women treated with the fCO2 laser fCO2 Laser Therapy Group: Women enrolled in the study will receive three treatments with the fractional carbon dioxide (fCO2) laser. The interval between treatments is approximately six weeks. Intra-vaginal laser treatments will be delivered at 8 points at each level of the vaginal wall. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||||
| Region of Enrollment | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Patient Global Impression of Improvement (PGI-I) Score at 4 Weeks After Initial Treatment | PGI-I score is recorded 4 weeks after initial treatment completion. The PGI-I asks the patient to "check the box that best describes how your urinary and/or vaginal symptoms are now, compared with how you symptoms were before you began this study." There are 7 possible responses ranging from 1 to 7, where 1 is "Very Much Better", 2 is "Much Better, 3 is "A Little Bit Better", 4 is "No Change", 5 is "A Little Worse", 6 is "Much Worse", and 7 is "Very Much Worse". A score from 1 to 3 would indicate improvement. | Posted | Mean | Standard Deviation | score on a scale | 4 weeks post-initial treatment |
|
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| ||||||||||||||||||||||||||
| Secondary | Change in Patient Global Impression of Improvement (PGI-I) Score | The average change in patients' PGI-I scores from baseline to 6 months and 36 months post-treatment. The PGI-I asks the patient to "check the one number that best describes how your urinary tract condition is now compared with how it was before your treatment." There are 7 possible responses ranging from 1 to 7, where 1 is "Very Much Better" and 7 is "Very Much Worse". A lower score would represent improvement and a favorable outcome. | Not Posted | 6 months and 36 months post-initial treatment | Participants | |||||||||||||||||||||||||||||||
| Secondary | Change in Vaginal pH and Overall Vaginal Health on Physical Exam as Measured by the Vaginal Health Inventory Score (VHIS). | The Vaginal Health Inventory Score (VHIS) is an assessment tool, used by providers, to determine if vaginal atrophy is present. Providers perform a vaginal exam and give a score of 1-5 (abnormal to normal, respectively) on each of the following vaginal parameters: elasticity, secretion/fluid volume, vaginal pH, integrity of the epithelium, and lubrication/moisture of the vaginal wall. A VHIS score less than 15 is indicative of vaginal atrophy. | Not Posted | 6 months and 36 months post-initial treatment | Participants | |||||||||||||||||||||||||||||||
| Secondary | Change in Urinary Symptoms as Measured by the Questionnaire for Urinary Incontinence Diagnosis (QUID). | Patients will complete the QUID, which consists of 6 questions. Responses to the questions indicate the frequency of urinary incontinence. Scores are: 0 (none of the time), 1 (rarely), 2 (once in awhile), 3 (often), 4 (most of the time), or 5 (all of the time). Responses to items 1, 2, and 3 are summed for the Stress Urinary Incontinence Score. Responses to items 4, 5, and 6 are summed for the Urge Incontinence Score. | Not Posted | 6 months and 36 months post-initial treatment | Participants | |||||||||||||||||||||||||||||||
| Secondary | Change in Overactive Bladder (OAB) Symptoms as Measured by the Overactive Bladder Questionnaire-Short Form (OAB-q SF). | The OAB-q SF consists of two scales assessing symptom bother and health-related quality of life (HR-QOL) in patients with OAB. Each question is rated on a 6 point scale with 1 = Not at all and 6 = A very great deal. | Not Posted | 6 months and 36 months post-initial treatment | Participants | |||||||||||||||||||||||||||||||
| Secondary | Change in Voiding Diaries. | A 3-day voiding diary will be completed by the patient and evaluated to describe urinary frequency and incontinence episodes. | Not Posted | 6 months and 36 months post-initial treatment | Participants | |||||||||||||||||||||||||||||||
| Secondary | Change in Sexual Function, Including Dyspareunia Symptoms, as Measured by the Female Sexual Function Inventory (FSFI). | The FSFI consists of 6 subscales related to sexual desire (2 Qs scale 1 worst - 5 best), arousal (4Qs 0 worst - 5 best), lubrication (4Qs 0 worst-5 best), orgasm (3Qs 0 worst - 5 best), satisfaction ( 3Qs 0 worst - 5 best), and pain (3 Qs 0 worst - 5 best). Higher scores indicate higher sexual functioning. Scores range from 2-36. A score of 26.55 has been clinically selected as the cut-off for sexual dysfunction. Scores below this value indicate sexual dysfunction. | Not Posted | 6 months and 36 months post-initial treatment | Participants | |||||||||||||||||||||||||||||||
| Secondary | Change in Frequency of UTI Occurrences, as Measured by a Positive Urine Culture Test. | A clean catch urine specimen will be collected at each visit. A positive urine dipstick test will have the presence of leukocytes and nitrites accompanied by symptoms (dysuria, bladder pain, and/or urinary frequency). | Not Posted | 6 months and 36 months post-initial treatment | Participants | |||||||||||||||||||||||||||||||
| Secondary | Change in Mental Health Status as Measured by the Generalized Anxiety Disorder Questionnaire (GAD-7). | The GAD-7 is a self-reported questionnaire for screening and measuring severity of generalized anxiety disorder. There are 7 questions total, each answer is scored on a scale from 0 = not at all to 3 = nearly every day. Scores greater than or equal to 10 indicate moderate anxiety and further assessment is recommended. | Not Posted | 6 months and 36 months post-initial treatment | Participants | |||||||||||||||||||||||||||||||
| Secondary | Change in Mental Health Status as Measured by the Patient Health Questionnaire (PHQ-8). | The PHQ-8 is an eight item questionnaire that is a valid diagnostic and severity measure for depressive disorders. Each question is scored from 0 = not at all to 3 = nearly every day. A score of 10 or greater is considered major depression and a score of 20 or more as severe major depression. | Not Posted | 6 months and 36 months post-initial treatment | Participants | |||||||||||||||||||||||||||||||
| Secondary | Change in Life and Sexual Impact of Vulvovaginal Skin Symptoms. | The Incontinence Quality of Life Questionnaire (I-QOL) is a validated tool to assess the impact of urinary incontinence problems. The I-QOL has 22 incontinent-specific quality of life items all having the following five-point ordinal response scale: 1= Extremely, 2= Quite a Bit, 3= Moderately, 4= A Little, and 5= Not at All. Total I-QOL is a combined score of all items. All 22 items are summed to calculate a total I-QOL score, ranging from 22 to 110, with a high score indicating a better quality of life. The 22 items are broken down into 3 subscales: Avoidance and Limiting Behaviors Score (8 of the 22 items), Psychosocial Impacts Score (9 of the 22 items), and Social Embarrassment Score (5 of the 22 items). Scores are summed based on the same 5-point scale. 1= Extremely, 2= Quite a Bit, 3= Moderately, 4= A Little, and 5= Not at All. A high score indicates a better quality of life. | Not Posted | 6 months and 36 months post-initial treatment | Participants | |||||||||||||||||||||||||||||||
| Secondary | Change in the Presence of Lactobacillus, Assessed by Vaginal Swab. | Presence or absence of lactobacillus will be collected by the physician via a vaginal swab and assessed under the microscope. | Not Posted | 6 months and 36 months post-initial treatment | Participants |
3 years
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | fCO2 Laser Therapy Group | Women treated with the fCO2 laser fCO2 Laser Therapy Group: Women enrolled in the study will receive three treatments with the fractional carbon dioxide (fCO2) laser. The interval between treatments is approximately six weeks. Intra-vaginal laser treatments will be delivered at 8 points at each level of the vaginal wall. | 0 | 80 | 0 | 80 | 64 | 80 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pudendal nerve pain | Nervous system disorders | Systematic Assessment |
| ||
| Vaginal bleeding | Reproductive system and breast disorders | Systematic Assessment |
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| Urinary Tract Infection | Infections and infestations | Systematic Assessment |
| ||
| vaginal pain | Reproductive system and breast disorders | Systematic Assessment |
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| Vaginal yeast infection | Infections and infestations | Systematic Assessment |
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| Vaginal Burning | Reproductive system and breast disorders | Systematic Assessment |
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| Urethral mass | Renal and urinary disorders | Systematic Assessment |
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| Bladder pressure | Renal and urinary disorders | Systematic Assessment |
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| Flank pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Dysuria | Renal and urinary disorders | Systematic Assessment |
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| Increase urinary urgency | Renal and urinary disorders | Systematic Assessment |
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| Vaginal infection - not specified | Reproductive system and breast disorders | Systematic Assessment |
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| ovarian cysts | Reproductive system and breast disorders | Systematic Assessment |
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| positive urine dipstick | Renal and urinary disorders | Systematic Assessment |
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| Bacterial vaginosis | Infections and infestations | Systematic Assessment |
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| Pain during treatment | Injury, poisoning and procedural complications | Systematic Assessment |
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| Suspected urinary calculus | Renal and urinary disorders | Systematic Assessment |
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| Suspected bacterial vaginosis | Infections and infestations | Systematic Assessment |
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| Discomfort with probe insertion | Injury, poisoning and procedural complications | Systematic Assessment |
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| Vaginal burning during treatment | Reproductive system and breast disorders | Systematic Assessment |
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| Flare of pelvic floor muscle | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Rash - Allergic reaction to Cipro | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Worsening dyspareunia | Reproductive system and breast disorders | Systematic Assessment |
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| Vaginal itching | Reproductive system and breast disorders | Systematic Assessment |
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| Vaginal irritation | Reproductive system and breast disorders | Systematic Assessment |
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| Numbness to lower extremity and buttock | Nervous system disorders | Systematic Assessment |
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| Exacerbation of vaginal atrophy | Reproductive system and breast disorders | Systematic Assessment |
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| Left labial itching and redness | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Trauma to introitus during treatment | Injury, poisoning and procedural complications | Systematic Assessment |
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| Proteinuria | Renal and urinary disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jennifer Giordano | William Beaumont Hospital | 248-551-3517 | jennifer.giordano@corewellhealth.org |
| Dec 4, 2023 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D004414 | Dyspareunia |
| D014627 | Vaginitis |
| D014549 | Urinary Incontinence |
| D053201 | Urinary Bladder, Overactive |
| D014552 | Urinary Tract Infections |
| D014550 | Urinary Incontinence, Stress |
| ID | Term |
|---|---|
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D005832 | Genital Diseases, Male |
| D012735 | Sexual Dysfunction, Physiological |
| D052801 | Male Urogenital Diseases |
| D020018 | Sexual Dysfunctions, Psychological |
| D001523 | Mental Disorders |
| D014623 | Vaginal Diseases |
| D014555 | Urination Disorders |
| D014570 | Urologic Diseases |
| D059411 | Lower Urinary Tract Symptoms |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001745 | Urinary Bladder Diseases |
| D007239 | Infections |
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| Unknown or Not Reported |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|