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Ohio university is committed to providing a workplace, educational environment, and programs and activities that are free from sexual harassment and other sexual misconduct.

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Study record managers: refer to the Data Element Definitions if submitting registration or information.

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Cleveland Clinic will serve as the central Data Coordinating Center. Study Identification and Recruitment Potential subjects will be identified Cleveland members of the sections of Urogynecology and Reconstructive Pelvic Surgery and Benign Gynecology at the mature institutions. Eligible patients who submit to participate will be provided written informed consent administered by the collaborators listed on this IRB.

Randomization The participants will then be randomized to either fractional CO2 vaginal laser therapy or vaginal estrogen cream according to a computer-generated randomization schedule with random block sizes with the use of the SAS statistical software package SAS Institute, Cary, NC. All patients will be unblinded to their asment. Completion of these questionnaires should take no more than minutes. A vaginal maturation index will be obtained at the baseline visit on a regular Pap Smear side and fixed with cytofixative and air dried.

This will be repeated during the Ohio follow up visit at 6 months. Stack 1 is used at baseline and stack 3 at 6 weeks and 3 months. At the investigators discretion a flat probe vulvar probe may be Cleveland to more efficiently treat the introital area and vestibule. At the level of the vaginal introitus, the dot power will be decreased to 26 watts.

A treatment cycle includes three laser applications every days, approximately 6 weeks. The procedure will be performed in the outpatient clinic and does not require any specific preparation e. At the clinician's discretion, EMLA submit may be applied to introitus for thirty minutes and wiped clean and dried prior to vulvar laser therapy.

Patients will be recommended to avoid coital sexual activity for at least 3 days after each laser application because a mild inflammatory reaction may last up to 48 hours after laser therapy. Vaginal Estrogen Protocol The women in the vaginal estrogen group will be prescribed and asked to administer the conjugated estrogen cream 0.

Vaginal examinations Vaginal Health Index VHI Pussy including vaginal pH will be obtained using litmus mature during baseline and each follow-up examination Ohio recorded. This will be obtained during baseline, 6 week, 3 month, and 6 month pussy by a blinded examiner prior to assessment of vaginal wall elasticity with silastic dilators.

A limited vaginal exam will be performed to assess the condition of the vaginal area. This exam will include a vaginal calibration, performed with a standard vaginal dilator Syracuse Medical. The investigator will determine the largest dilator of the five sizes available XS, S, M, L, XLthat the subject can comfortably have placed in her vagina.

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The subject then assesses how much pain she is experiencing when the dilator is placed in her vagina, using a 5-point Likert scale. Questionnaires and evaluations Questionnaires will be administered by a research nurse coordinator who is blinded to the patient's therapy. Note that all patients will follow up 6 months from baseline visit for final assessment. Data points recorded during the procedure will include:.

Protection of each subject's personal health information will be a priority in this study. One master Excel file containing subject personal information including name and medical record will be kept in a password-protected file, on a deated protected research drive on a password-protected computer in a locked office at each respective institution.

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In that file, each subject will be ased a subject identification that will be used for the purposes of data collection in order to de-identify subjects. All paper forms used for data collection will be kept in a research cabinet dedicated to this project, which will be locked at all times, in a locked office at the Cleveland Clinic or other institution name. All forms will contain de-identified information.

Identification s will correspond to the subjects listed in the master excel file. Each subject will be entered into REDCap using the ased identification from the master excel file. Device: CO2 fractionated vaginal laser Intravaginal treatment with fractional microablative CO2 laser at baseline, 6 weeks and 3 months Other Name: MonaLisa Touch Active Comparator: Estrogens, Conjugated USP The women in the vaginal estrogen group will be prescribed and asked to administer the conjugated estrogen cream 0. Data presented is the mean difference before and after treatment.

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A higher mean difference ifies that the vaginal dryness score decreased to a greater measure hence resulting in a better outcome. The data presented are mean differences before and after treatment. Effect of Treatment on Vaginal Maturation Index [ Time Frame: 6 months ] Vaginal Maturity Index VMI scores are from 0 minimum to maximum with higher scores representing higher maturity which is a favorable better outcome.

The reported are the difference between 2 time points baseline and 6 month follow up.

A change in outcome which is negative ifies a worse outcome. Conversely, a positive change ifies improvement.

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Vaginal Wall Elasticity Assessed by of Participants Able to Tolerate a Larger Vaginal Dilator Size [ Time Frame: 6 months ] Participants who were able to tolerate a larger dilator size compared to before treatment representing improvement in vaginal wall elasticity were marked as "yes" and participants who could not tolerate a larger size representing no change in vaginal elasticity were marked as "no".

The scores represent the difference between baseline and 6 month follow up. A negative difference ifies worsened function whereas a positive difference ifies improvement.

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Effect of Treatment on Urinary Symptoms [ Time Frame: 6 months ] Urogenital distress inventory UDI-6 is measures on a scale of 0 minimum to 75 maximum with higher scores representing less favorable outcomes more severe urinary symptoms. Data here are presented as mean differences from before and after treatment. The 5-point Likert scale for satisfaction indicates 1 Very dissatisfied2 Dissatisfied3 Same4 Satisfied or 5 Very satisfied. As reported, the responses for level of dissatisfaction after treatment on the Patient Global Index included responses of very dissatisfied and dissatisfied.

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This is directly out of the questionnaire given to the patient to complete. Talk with your doctor and family members or friends about deciding to a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below.

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For general information, Learn About Clinical Studies. Hide glossary Glossary Study record managers: refer to the Data Element Definitions if submitting registration or information. Search for terms x. Save this study. Warning You have reached the maximum of saved studies Listing a study does not mean it has been evaluated by the U. Federal Government.

Read our disclaimer for details. First Posted : October 17, Last Update Posted : October 30, Study Description.

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Show detailed description. Hide detailed description. Detailed Description:. Cleveland Clinic Ohio serve as the central Data Coordinating Center Study Identification and Recruitment Potential subjects will be identified by members of the sections of Urogynecology and Reconstructive Pelvic Surgery and Benign Gynecology at the respective institutions. Post Treatment Instructions Each subject shall be evaluated immediately post-treatment for complications and side effects, excessive bleeding, symptomatic vaginal discharge, pain, etc.

Each study subject will be asked to assess discomfort of treatment using a 5-point Likert scale. The mature will be instructed on the Cleveland activity limitations following the procedure, sedentary activities are recommended for a least a few days.

The subject will not engage in pussy exercise or submit sports for at least 72 hours, or until approved by the physician. The subject will refrain from douching for at least 72 hours after the procedures.

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Subjects will not engage in intercourse for at least 72 hours post procedure. The subject may shower but may not bathe the day following the procedure. They will use regular shower gel or soap. GSM symptom vaginal dryness, vaginal burning, vaginal itching, dysuria will be assessed using the VAS. Patient evaluation of the overall treatment PGI using a 5-point Likert scale will be conducted at 6 week, 3 month and 6 month follow-up visits. After each treatment, the PI or co-investigator will be asked to evaluate the ease of treatment using a 5-point Likert scale.

After each treatment, the subject will be asked the degree of discomfort experienced as a result of treatment using a 5-point Likert scale. Events will be evaluated and recorded.

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Adverse events including inability to complete the procedure due to discomfort or constricted vagina Post-procedure data will include the following: The rate of satisfaction of patients with treatment by mean of the Patient Global Impression of Improvement PGIusing a 5-point Likert scale. The degree of difficulty encountered by the physician in performing the treatment, by mean of a 5-point Likert scale. Additionally, untoward side effects of treatment such as new bothersome vaginal irritation and ificant vaginal bleeding will be recorded.

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Drug Information available for: Estrogens, conjugated Estrogens. FDA Resources. Arms and Interventions. Intravaginal treatment with fractional microablative CO2 laser at baseline, 6 weeks and 3 months.