Health Condition 1: F528- Other sexual dysfunction not due to a substance or known physiological condition
Conditions
Interventions
Intervention1: BTL-398 with 398-AP-MA-3 applicator: The BTL-398 device equipped with 398-AP-MA-3 applicator utilizes simultaneous delivery of electromagnetic technology (HIFEM) and pressure waves (PWT
Sponsors
BTL India Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1.Scoring less than 26.55 points in FSFI 2.Female subjects over 18 years of age seeking improvement of sexual dysfunction 3.Sexually active (having intercourse at least once a month) 4.Subjects should be able to understand the investigative nature of the treatment, the possible benefits and side effects, and must sign the Informed Consent Form. 5.Subjects are willing and able to comply with protocol requirements, including obtaining study-required assessments and returning for follow-up visits 6.Subjects willing and able to abstain from partaking in any treatments other than the study procedure to treat sexual dysfunction during study participation 7.Women of childbearing potential are required to use birth control measures
Exclusion criteria
Exclusion criteria: 1.cardiac pacemakers2.implanted defibrillators, implanted neurostimulators3.electronic implants 4.pulmonary insufficiency 5.any metal implants in the vicinity of the treated area 6.drug pumps 7.decompensated hemorrhagic conditions 8.decompensated blood coagulation disorders 9.malignant tumor 10.fever 11.pregnancy 12.previous surgical or non-surgical treatments in the treated area within the last six months 13.Subjects enrolled in another investigational study within the past 30 days14.14.any other disease or condition at the investigator s discretion that may pose risk to the patient
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.At least 80% of the treated subjects reported satisfaction (level satisfied or very satisfied) with the therapy outcome at 90 days using the Subject Satisfaction Questionnaire. 2.Evaluation of the therapy comfort during the therapy with BTL-398 device via the Therapy Comfort Questionnaire.Timepoint: The results of individual questions from the FSFI questionnaire will be analysed. The following data will be evaluated at 30-day follow-up: 1.FSFI questionnaire score 2.individual questions from the FSFI questionnaire 3.Subject Satisfaction Questionnaire 4.Body weight and subsequently BMI | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.At least 80% of the treated subjects reported satisfaction (level satisfied or very satisfied) with the therapy outcome at 90 days using the Subject Satisfaction Questionnaire. 2.Evaluation of the therapy comfort during the therapy with BTL-398 device via the Therapy Comfort Questionnaire.Timepoint: The results of individual questions from the FSFI questionnaire will be analysed. The following data will be evaluated at 30-day follow-up: 1.FSFI questionnaire score 2.individual questions from the FSFI questionnaire 3.Subject Satisfaction Questionnaire 4.Body weight and subsequently BMI | — |
Countries
India
Contacts
Public ContactDr Ramya K S
sunshine Healthcare Clinic
Outcome results
None listed