Viveve Medical, Inc. · OTC:VIVE
Viveve Medical — Technical Presentation (2010)
22 slides from Viveve Medical's technical presentation, 2010
Slide 1: A Cross-Sectional Survey to Assess the Symptoms Associated with and Prevalence of Vaginal Laxity
A Cross-Sectional Survey to Assess the Symptoms Associated with and Prevalence of vaginal Laxity
Slide 2: Background
Background • Vaginal laxity may occur following vaginal delivery • Infrequently discussed condition between patients and clinicians • Laxity may lead to loss of physical sensation and reduction in sexual satisfaction • Paucity of data available regarding the impact of vaginal laxity on sexual functi
Slide 3: Aims of Study
Aims of Study • Explore the relationship between vaginal laxity and changes in genital sensation or sexual satisfaction • Quantify the prevalence of vaginal laxity among parous women
Slide 4: Study Design
Study Design • Two phases: – 1st Phase • Qualitative: Cross-sectional survey utilizing focus groups – 2nd Phase • Quantitative: on-line survey
Slide 5: Qualitative phase: Recruitment
Qualitative phase: Recruitment • Nine focus groups: Portland, OR; Cleveland, OH; Atlanta, GA -5-8 women per group -n= 50 • Inclusion criteria: – women aged 25-45 – had at least one vaginal delivery – self-reported changes in vaginal sensitivity and/or tone
Slide 6: Qualitative phase: demographics
Qualitative phase: demographics Portland Atlanta Cleveland Race 100% caucasian 2/3 caucasian 2/3 caucasian 1/3 african american 1/3 african american Age Greater than 50% Greater than 50% Greater than 50% between 25-35 yrs between 25-35 yrs between 25-35 yrs Employment Status Mix of working and Prima
Slide 7: Procedure
procedure • Moderated focus group • Duration: 2 hours • To understand the mindset, attitudes, experience and perceived unmet need to address the issue of vaginal laxity • Compensation: $100
Slide 8: Qualitative Phase: Results
Qualitative Phase: Results • Most of the subjects perceived laxity as a concern • Subjects didn’t talk about it with their doctors, spouse/partner, or friends • Subjects felt as though they were ‘suffering in silence’ with this condition
Slide 9: Qualitative phase: results
Qualitative phase: results • Subjects’ description of the complexity of physical and emotional consequences due to vaginal laxity Difficulty Reduced Feeling old, Reaching sensation worn out Orgasm Burdensome Yearning for Loss of Sexual Intimacy and Sexuality Performance Confidence
Slide 10: Impedance to Discussing Sexual Concerns
Impedance to Discussing Sexual Concerns • Embarrassment • Physicians can’t relate – age, i.e. “too old” or “too young” – not a woman, doesn’t have children • Ability to articulate the problem • No validation of the problem
Slide 11: Quantitative phase: Demographics
Quantitative phase: Demographics • 421 of 635 women who received questionnaire completed survey • Inclusion criteria: age: 25-55; at least one vaginal delivery • Median age: 41.4 • Representation from every state of the continental U.S. • Respondent demographics: – 81% Caucasian – 55% college gradua
Slide 12: Quantitative phase: results
Quantitative phase: results •Some of the survey responses related to concerns about self-image, sexuality and sexual satisfaction p-value <0.001 0.676 <0.001 <0.001 0.047 <0.001 <0.001 <0.001 <0.001
Slide 13: Vaginal Laxity Prevalence
Vaginal Laxity Prevalence • When asked: ‘Since having children, to what degree has vaginal looseness been a concern for you?’ nearly half responded it was a concern 48% 22%
Slide 14: Vaginal laxity by age group
Vaginal laxity by age group 25-35 yrs old 36-45 yrs old 46-55 yrs old (%) (%) (%) 5 (a lot) 11 9 6 4 17 10 13 3 27 24 27 2 27 23 20 1 (not at all) 18 34 34 Subjects in the 25-35 year old group rated a higher concern for vaginal laxity than the two older age groups
Slide 15: Discussion of the Condition
Discussion of the Condition
Slide 16: Subject/Clinician Interaction
Subject/Clinician Interaction According to the 25-35 years old 36-55 years old data, the younger the survey respondent, the more likely she is to: Talk to her OB/GYN about her sex life 69% 49%
Slide 17: Benefit of Improving Vaginal Laxity
Benefit of Improving Vaginal Laxity Strongly Benefit Statement Agree/Agre e Benefit Me and My Partner 65% Would improve my sexual satisfaction 59% Positive effect on my relationship with my partner 56% I would have better orgasms 55% I would feel more confident during lovemaking 53%
Slide 18: Kegels
Do you know how Have you ever done Do you think Kegels kegels are done? _ Kegels to tighten are effective in your vagina? tightening the Byes MNo ®Don't Know vagina?
Slide 19: Conclusions
Conclusions • Provides a new focus on vaginal laxity – As an important quality of life concern after vaginal childbirth – One that is infrequently discussed between patients and physicians and under-reported in the literature • Unique in assessing women’s attitudes about body image, sexual health an
Slide 20: Conclusions
Conclusions • Among 25-55 year old women who’ve had at least one vaginal childbirth, approximately half expressed some degree of concern for vaginal laxity • Future research is needed to identify effective non-surgical treatment modalities for vaginal laxity
Slide 21: Limitations
limitations • Applicability to broader population – On-line access – Education level • Objective measurement tool not utilized
Slide 22: Thank you
Thank you