Product Highlight
Condition targeted:
Vaginismus, dyspareunia and genito pelvic pain/penetration disorder (GPPPD)
How it works:
GPPPD is the most prevalent sexual dysfunction for women and individuals with vaginal anatomy. It refers to pain, discomfort and anxiety related to vaginal penetration. HelloBetter Vaginismus Plus is an online program that helps individuals with GPPPD overcome the psychological and physiological symptoms associated with the condition. It was developed and evaluated by a team of scientists, women’s health experts and psychotherapists and is based on well-established methods from cognitive behavioral therapy (CBT). This program was extensively studied and found to be effective in two randomized controlled trials. It also has high satisfaction rates with 97.2% saying that they would recommend the program to a friend.
Impact:
Clinically proven to make sexual and non-sexual vaginal penetration possible and significantly reduce penetration-related anxiety, genital pain and other pain-related impairments.
Product Overview
Medical condition:
Adults who experience pain during vaginal penetration and meet the criteria for the ICD-10 codesF52.5 Organic Vaginismus and F52.6 Non-Organic Vaginismus.
Target patient population:
Women and individuals with vaginal anatomy over the age of 18 who wish to overcome the pain, anxiety and discomfort they may experience related to vaginal penetration.
What to expect:
HelloBetter Vaginismus Plus is a 12-week program that is structured into eight core units and an additional follow-up unit. Numerous exercises help individuals – alone or with their partner – to combat the fears and challenges associated with the topic. Step-by-step, the program teaches clients about their sexual anatomy, how to practice relaxation and pelvic floor exercises, and learn to insert a dilator.
Note: for more information, please visit https://hellobetter.de/en/online-courses/vaginismus-plus/
Clinical Overview
Indications for use:
HelloBetter Vaginismus Plus is a digital therapeutic aimed at reducing the anxiety, pain and discomfort related to vaginal penetration.
Outcomes:
Clinically proven to make sexual and non-sexual vaginal penetration possible and significantly reduce sexual anxiety, genital pain and pain-related impairments.
Directions:
HelloBetter Vaginismus Plus delivers well-founded psychoeducation via text, video and audio recordings, and teaches the well-established methods of cognitive behavioral therapy (CBT). These include strategies for dealing with stressful thoughts and feelings, pelvic floor and relaxation exercises, sensate focus and step-by-step vaginal penetration exercises with dilators. The exercises are taught throughout the units and can be integrated into everyday life. Goals are set and formulated in such a way that they are specific, realistic and achievable. The online course consists of eight core units and an additional follow-up unit. Each unit takes approximately 45-60 minutes to complete. In addition to the course units and practical exercises, the program grants access to an online journal, and recurring symptom checks to record, monitor and evaluate one’s own progress.
Risks & warnings:
HelloBetter Vaginismus Plus may not be suitable for people without internet, wifi, a mobile or desktop device. This digital therapeutic was developed and evaluated on adults aged 18 years and older.
Place in therapy:
Complementary to therapy or as a standalone solution. The program is also suitable for bridging the waiting time for a place in psychotherapy and as support after treatment has been completed.
Product Access
Product description:
HelloBetter Vaginismus Plus is accessible through mobile and web.
Prescription status:
A prescription is not required. In Germany, it has been listed as a digital health application (‘DiGA’), meaning that a diagnosis or prescription leads to universal reimbursement. However, individuals without a diagnosis can access the program through self-pay, or via their care provider.
Patient access:
Eligible users can access the program online or through the HelloBetter app on iOS or Android devices.
Use of this product requires access to:
- Internet or wifi
- and a mobile phone, tablet, or computer
Provider access:
Full provider access is given if providers (e.g. clinic) purchase HelloBetter through their ‘Software-As-A-Service’ offering, which allows providers to add patients, choose products for patients, guide the patients, through the product via messages, chat, and regular feedback, etc. Patients may choose to export their information via a downloadable file to certain healthcare providers. This file contains all relevant information on patient progress and symptoms and can be integrated with major EHRs going forward.
Coverage options:
In Germany, HelloBetter Vaginismus Plus is eligible for prescription and covered by statutory health insurance in Germany – making it available free of charge to over 73 million people.
Product availability:
HelloBetter Vaginismus Plus is available in:
- Germany: Class I CE mark (MDR)
- Switzerland: Class I CE mark (MDR)
- Austria: Class I CE mark (MDR)
Unique Features.
HelloBetter Vaginismus Plus is the first and only clinically-validated digital intervention for the treatment of Genito-pelvic pain/penetration disorder (GPPPD).
Clinical Trials
The provided set of evidence represents a sample of conducted studies. For a comprehensive collection contact manufacturers directly.
- Study Title: Efficacy of internet-based treatment for genito-pelvic pain/penetration disorder: Results of a randomized controlled trial – 2021
Study Design: Randomized controlled trial
Outcomes: In this study, conducted on individuals who had not had sexual intercourse with their partner in over six months, 31 % of participants reported that they were able to engage in penetrative sex again after using the program. Compared to a control group, participants that used HelloBetter Vaginismus Plus experienced a significant greater reduction in pain and anxiety before or during sexual intercourse or other sexual activity after 12 weeks. These effects remained stable at a 6 months follow-up. - Study Title: Internet-Based Guided Self-Help for Vaginal Penetration Difficulties: Results of a Randomized Controlled Pilot Trial – 2017
Study Design: Randomized controlled trial
Outcomes: After using the program, 34.5% of the participants that used HelloBetter Vaginismus Plus were able to have penetrative sex to only 20.7% of those in the waitlist control group. Additionally, there were significant effects concerning non-intercourse penetration.
Note: for more research, please visit https://hellobetter.de/en/research/