A PROSPECTIVE MULTICENTRE RANDOMISEDCONTROLLED TRIAL OF QUALITY OF LIFE AND SEXUAL SATISFACTION COMPARINGCLINICIAN ASSISTED PELVIC FLOOR EXERCISES WITH PERICOACH ASSISTEDPELVIC FLOOR EXERCISES IN THE MANAGEMENT OF FEMALE STRESS URINARYINCONTINENCE
Womens PelvicHlth.Inst., Los Gatos, CA.
Introduction: Urinaryincontinence causes social embarrassment and lack of confidence forsexual engagement1. Pelvic Floor Muscle Exercises (PFME)done properly develop PFM strength, reducing incontinence and shownto influence sexual dysfunction2. PeriCoach is a sensordevice with Smartphone app for home use to assist performance andcompliance of PFME.
Objective: The aim of this study is ananalysis of quality of life and sexual satisfaction with relation touse of PeriCoach with clinician guided PFME.
Methods:Target enrolment of 90 female patients ≥18 years meeting inclusioncriteria undergo baseline screening prior to being randomized to oneof two groups: PeriCoach and PFME (PFME/PC) or standardclinician-guided PFME as practiced at each site. All patients aretrained to perform PFME as per standard clinic practice. PFME/PCgroup are also trained on device use. The Sexual Questionnaire(PISQIR IUGA) was collected only at baseline and week 20. Change frombaseline to week 20 was analyzed and compared between the groups forthe sexually active participants (Q7-Q20). Q7-11, 15-20 from Section2 are presented graphically in Figure 2 (Blue: PFME; Pink:PFME/PC).
Results: Enrolment concluded with 47 patients(mean age 41.2 years) randomized between the groups at conclusion oftrial. Of the 38 subjects available at baseline (18 and 20) weresexually active and filled out the questionnaire, with 30 subjects(13 and 17) still active at week 20. The overall sexual satisfactionscore increased (p=0.0765) for the PFME/PC, but worsenedsignificantly (0.0273) for the PFME group by week 20. The groupeffect was highly significant (p=0.0061) when compared change frombaseline between the groups in favor of PFME/PC. Also Figure 2, Q8,emotional state manifesting during sexual activity (TranslationProtocol PISQ-IR, page 19), showed improved shame and fear score forthe PFME/PC. The response data for Q18 also supports this improvementfurther, with reduced fear scores with relation to fear of urineleakage during sexual activity.
Conclusions: PeriCoach, asensor device and smartphone app for assisting patients to performand comply with PFME, is being studied in women with stressincontinence. Preliminary data shows that the PeriCoach may offerassistance in early improvement of urinary incontinence for thesexually active subject and increase their overall sexualsatisfaction. Results support the PeriCoach use as showing superiorsexual satisfaction outcomes when compared with the PFME group, andwhen looking at the individual question scores, it may indicate thatthe biofeedback of the PeriCoach leads to improved overallconfidence.
References: 1. Bo, 1999 2. de Mendes, 2016