BMC women's health · 2022
Novel, disposable, self-inserted, vaginal device for the non-surgical management of pelvic organ prolapse: efficacy, safety, and quality of life.
Многоцентровое исследованиеСтатьяПоддержка исследования: вне правительства СШАНазвание и аннотация: Перевод пока не подготовлен
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Ziv Elan, Erlich Tsvia
Аннотация
BACKGROUND: We evaluated a novel disposable, collapsible, ring-shaped vaginal device that is self-inserted within an applicator and removed with a string. The device was developed to overcome the drawbacks of existing ring pessaries for non-surgical pelvic organ prolapse management (POP).
METHODS: The primary objective efficacy endpoint of this prospective, interventional, multicenter, self-controlled, and home-use study was the proportion of subjects with improved staging on the Pelvic Organ Prolapse Quantification (POP-Q) scale. Subjective efficacy was assessed using the POP symptoms alleviation score. Safety was evaluated by recording the rate and incidence of adverse events (AEs) in a daily diary, and quality of life (QoL) was evaluated using the modified Pelvic Floor Impact (PFIQ-7) and Pelvic Floor Disability Index (PFDI-20) questionnaires.
RESULTS: A total of 94 usage cycles were observed in a group of 52 participants (mean age 60.2 ± 10.5 years, 81.1% postmenopausal) who used the device for 3558 days. Of these, 24 participants completed one usage cycle, 14 completed two usage cycles, and 14 completed three usage cycles with 28-45 days of ProVate use in each usage cycle. All patients experienced greater than two POP-Q stage reductions. The descent was completely reduced to POP-Q stage 0 in 97.8% of participants. The POP symptom alleviation questionnaire showed significant subjective efficacy (P < 0.0001). The modified PFDI-20 and PFIQ-7 scores also improved substantially (P < 0.0001 for both). There were 91 nonserious device-related AEs: 98.9% were mild and 87.9% anticipated, with no vaginal infection, and one case of urinary tract infection.
CONCLUSION: The novel device substantially reduces prolapse and provides significant subjective POP symptom relief and QoL improvement, with minimal AEs. The device may enable women to self-manage their prolapse with a small, disposable device that minimizes self-touching and frequent dependency on the clinic.
TRIAL REGISTRATION: Clinical.
TRIALS: gov , NCT02239133 , posted September 12, 2014 (retrospectively registered).
METHODS: The primary objective efficacy endpoint of this prospective, interventional, multicenter, self-controlled, and home-use study was the proportion of subjects with improved staging on the Pelvic Organ Prolapse Quantification (POP-Q) scale. Subjective efficacy was assessed using the POP symptoms alleviation score. Safety was evaluated by recording the rate and incidence of adverse events (AEs) in a daily diary, and quality of life (QoL) was evaluated using the modified Pelvic Floor Impact (PFIQ-7) and Pelvic Floor Disability Index (PFDI-20) questionnaires.
RESULTS: A total of 94 usage cycles were observed in a group of 52 participants (mean age 60.2 ± 10.5 years, 81.1% postmenopausal) who used the device for 3558 days. Of these, 24 participants completed one usage cycle, 14 completed two usage cycles, and 14 completed three usage cycles with 28-45 days of ProVate use in each usage cycle. All patients experienced greater than two POP-Q stage reductions. The descent was completely reduced to POP-Q stage 0 in 97.8% of participants. The POP symptom alleviation questionnaire showed significant subjective efficacy (P < 0.0001). The modified PFDI-20 and PFIQ-7 scores also improved substantially (P < 0.0001 for both). There were 91 nonserious device-related AEs: 98.9% were mild and 87.9% anticipated, with no vaginal infection, and one case of urinary tract infection.
CONCLUSION: The novel device substantially reduces prolapse and provides significant subjective POP symptom relief and QoL improvement, with minimal AEs. The device may enable women to self-manage their prolapse with a small, disposable device that minimizes self-touching and frequent dependency on the clinic.
TRIAL REGISTRATION: Clinical.
TRIALS: gov , NCT02239133 , posted September 12, 2014 (retrospectively registered).