Development of a novel intravaginal device for rehabilitating women with pelvic organ prolapse: Investigating safety and feasibility of use.

Monash University0 个研究点目标入组 10 人开始时间: 2023年2月8日最近更新: 2023年2月13日

适应症

试验速览

暂无简介。

•The women in the following group:
•1.Women above 18 years of age
•2.Women with POP-Q Stage 2 or 3
•The clinicians included in this study will be the pelvic floor physiotherapists administering IVES to the patient. As such, the clinicians will not be considered participants for recruitment but their feedback on the application to the patient will be sought to understand usability.

•1.Women below 18 years of age
•2.Patients with an intellectual impairment
•3.Women with an allergy to nickel or stainless steel.
•4.People in existing dependent or unequal relationships with any member of the research team, the researcher(s) and/or the person undertaking the recruitment/consent process
•5.People highly dependent on medical care
•6.Women with a pre-existing cardiac condition and/or possess a cardiac pacemaker or neuromodulation device
•7.Women with an active implantable medical device
•8.Women with an active deep vein thrombosis
•9.Women who are pregnant or within a period of 3 months post-partum
•10.Women with any known or suspected tissue damage (eg. levator avulsion) or malignancy, active infection/disease in the vaginal region, impaired vaginal sensation, recently radiated tissue, or recent history of gynaecological surgery

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