Urinary Incontinence Clinical Trial
Official title:
An Open-Label Uncontrolled Single Centre Study for the Evaluation of the Performance Characteristics (Efficacy and Safety) of the Dermal Filler MMG-23-04-2019 (Hyaluronic Acid 2,0%) for Female Intimate Area Hydration and Atrophy of the Vagina.
Verified date | December 2020 |
Source | Mesoestetic Pharma Group S.L. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The study is an open-label uncontrolled single-center study for the evaluation of the Performance characteristics (efficacy and safety) of the dermal filler "MMG-23-04-2019" on the female genital area for the medicinal, functional and reconstructive indications.
Status | Completed |
Enrollment | 37 |
Est. completion date | August 17, 2020 |
Est. primary completion date | June 12, 2020 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Female subject aged =18; - Subject presenting vaginal atrophy, dryness, dyspareunia or discomfort in the intimate area; - Subject who presents no other type of pathology of the area to be treated; - Subject who is willing to abstain from any cosmetic or surgical procedures in the treatment area during the clinical investigation; - Subject who is willing to participate in all study related activities and who is available for the duration of their participation in the investigation for follow-up; - Absence of a history of significant hypersensitivity to food and drugs or known sensitivity to hyaluronic acid; - Clinically and anamnestic healthy individual; - Arterial blood pressure (BP) (after 5 min. at rest in the supine position) systolic 90 - 140 mmHg and diastolic 50 - 90 mmHg; - Heart rate (HR) (after 5 min. at rest in the supine position) over 50 beats/min and less than 90 beats/min; - Respiratory rate between 12 - 24 breaths/min; - An axillar body temperature of up to 37 degrees celsius; - Clinical-laboratory examinations within the reference ranges or with no clinically significant abnormalities; - Negative AIDS/HIV test; - Negative pregnancy test for the women with reproductive potential; - A reliable and acceptable method of contraception for the women of child-bearing potential: - Signed written Informed Consent Form Exclusion Criteria: - Subject with known sensitivity to hyaluronic acid or significant hypersensitivity to food and drugs; - Subject with a history of vulvar cancer and/or previous regional radiotherapy; - Subject with genital prolapse with a surgical indication or stress incontinence with a surgical indication; - A subject who suffers from vaginism; - Subject with genital bleeding of unknown origin; - Subject with frequent or present active herpes simplex or herpes zoster local infection or active herpes simplex or herpes zoster infection in other sites; - Subject with a history of frequent or active local dermatitis (of the injection site), vulvar scaly papilloma, mycosis; bacterial infection or laboratory tests indicating for such; - A subject suffering from autoimmune diseases or who are undergoing treatment with immunosuppressors or immunotherapy; - Subject with uncontrolled systemic diseases or who are undergoing current treatment with antihypertensives, steroid anti-inflammatory drugs anticoagulants, aspirin, major antidepressants; - Pregnancy, postpartum period (6 months), lactation or post-lactation period (6 months); - Absence of a reliable and effective method of contraception for a subject with childbearing potential; - Subjects who are currently receiving another investigational treatment or who had participated in another clinical investigation within 30 days prior to study enrollment; - A subject who suffer from another medical condition or who are receiving medication that in the Principal Investigator's judgment would prohibit the inclusion in the study; - Subject with limited mental activity and consistent comprehension ability; sportsmen and individuals on strenuous physical loading; prisoners; - Refusal to sign the Informed Consent Form. |
Country | Name | City | State |
---|---|---|---|
Bulgaria | Medical Centre Ramus | Sofia |
Lead Sponsor | Collaborator |
---|---|
Mesoestetic Pharma Group S.L. |
Bulgaria,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Vaginal Maturation Index (VMI) absolute change | Improvement in the properties of the vaginal wall, measured by the VMI. | From baseline to Day 60 (up to 8 weeks). | |
Primary | Treatment-Emergent Adverse Events [Safety and Tolerability] | Frequency and severity of adverse events (AEs) and adverse device effect | From screening through study completion, an average of 60 days - daily. | |
Secondary | The change in the Gloria Bachmann Vaginal Health Index (VHI) | The VHI is a score formed by 5 parameters (vaginal elasticity, vaginal secretions, pH, epithelial mucous membrane, vaginal hydration). The final score defines the degree of atrophy in the genitourinary tract by assigning a single score to each parameter. The maximum possible score is 25, while the minimum possible score is 5. | From baseline to Day 30 (4 weeks) and Day 60 (up to 8 weeks). | |
Secondary | The absolute change in Visual Analogous Scale (VAS). | The absolute change in VAS, ranged between 0 (no pain) and 10 (worst possible pain), judged by the Principal Investigator. | From baseline to Day 30 (4 weeks) and Day 60 (up to 8 weeks). | |
Secondary | The absolute change in Visual Analogous Scale (VAS) | The absolute change in VAS ranged between 0 (no pain) and 10 (worst possible pain), judged by the subject. | From Day 0 to Day 30 (4 weeks) and Day 60 (up to 8 weeks). | |
Secondary | The change of the Female Sexual Function Index (FSFI) score. | The FSFI is a validated questionnaire to measure the sexual functioning of women. The score ranges between 2 (minimum) and 36 (maximum). | From Day 0 to Day 30 and Day 60 (up to 4 weeks and 8 weeks respectively). | |
Secondary | Subject satisfaction evaluated by the Global Impression of Improvement (PGI-I) questionnaire | The PGI-I is a transition single question scale, asking the patient to rate their urinary tract condition now, as compared with how it was prior to before beginning treatment on a scale from 1 (Very much better) to 7 (Very much worse) | From Day 30 (4 weeks) to Day 60 (up to 8 weeks). | |
Secondary | The change if the Nugent Score | The Nugent Score is a Gram stain scoring system for vaginal swabs to diagnose bacterial vaginosis, relying on scoring of individual types of organisms; a score of 0 to 10 is derived from a weighted combination of the following: large Gram-positive rods (lactobacilli; decrease in Lactobacillus scored as 0 to 4), small Gram-negative or Gram-variable rods (G. vaginalis or other anaerobes; scored as 0 to 4), and curved Gram-negative or Gram-variable rods (Mobiluncus spp.; scored as 0 to 2). | From baseline to Day 60 (up to 8 weeks). | |
Secondary | Viganal biopsy (optional) | Evaluation of the mitotic activity of the mucosa (Ki-67 proliferation marker - %). | From Day 0 up to Day 60 (up to 8 weeks). | |
Secondary | Participant's Questionnaire | To register the overall discomfort and satisfaction of the subjects. | From Day 0 to Day 30 and Day 60 (up to week 4 and 8 respectively). |
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