Preliminary Results From a Multicenter Study on the Use of a New Device for the Treatment of Genito Pelvic Pain Disorders

Abstract

ABSTRACT Introduction Genito-pelvic pain/penetration disorder (GPPPD) causes painful sex, emotional distress, depression, as well as feelings of inadequacy and sexual frustration, which may gradually trigger problems with other domains of sexual functioning in the majority of diagnosed women. One in ten women suffers from GPPPD according to recent studies of prevalence with a wide range of psychosocial consequences. Treatment options in health care are limited. The majority of women with GPPPD do not receive appropriate treatment. Objective In this study, we will investigate the safety and preliminary evidence of the effectiveness of Crescendo Therapy System Kit (CTS) for the treatment of GPPPD. Methods A one-group pretest-posttest multicenter design was used in the current research. Main outcome measures were assessed using the Female Sexual Function Index (FSFI) domain for Sexual Pain at baseline and after 12 weeks. The collected data were tabulated and analyzed using the Statistical Package for the Social Sciences version 22 (SPSS). Quantitative data are expressed as means ± standard deviations (SDs). For the comparison of paired variables the Wilcoxon test was used. A total of 21 subjects, aged between 20 and 59 years of age (mean = 36.21 years, standard deviation (SD) = 12.29) were recruited, 11 patients completed CTS individually over 12 weeks. The inclusion criteria were as follows: Heterosexual woman aged 18 years or older, with a diagnosis of lifelong GPPPD, living in a relationship of at least 3 months, general health as evidenced by medical history. Exclusion criteria were: Absence of medical illness or use of other drugs known to interfere with sexual functioning, having received medication or psychological treatment for GPPPD in the last 6 months, medical cause, currently diagnosis post-traumatic stress disorder or psychosis/dissociative symptoms or depression or bipolar disorder.The CTS consists of 7 different exercises and an educational session online. Once the subjects finished each activity they were contacted for the next exercise with Crescendo device. Its objective is to provide patients with greater knowledge, awareness, and control of the excitation reflex and pelvic floor muscle activity using a bendable vibrator called Crescendo®. Results In the present study, there was a significant improvement score in domain of FSFI questionnaire Sexual Pain (mean pre = 0.40 (SD) = 0.61, mean post = 2.32 (SD) = 2.35, Wilcoxon test pre vs post p-value = 0.02). Conclusions In this study, we demonstrated that CTS was associated with a significant increase in the sexual pain domain score of the FSFI, with no adverse effects related to the treatment. We can conclude that CTS may have the potential to become an effective and safe treatment for patients suffering from GPPPD. Future studies with, larger group of patients, with larger follow-up and group control are needed. Disclosure Yes, this is sponsored by industry/sponsor: Mysteryvibe Clarification Industry funding only - investigator initiated and executed study