Evaluation of intravaginal electrical stimulation parameters in women with pelvic organ prolapse.

Monash University0 sites10 target enrollmentJune 8, 2023

Overview

No summary available.

Registry

who.int

Start Date

June 8, 2023

End Date

January 24, 2024

Last Updated

last year

Study Type

Interventional

Sex

Female

Sponsor

•The women in the following group:
•1\.Women 18 years of age or above
•2\.Women with Pelvic Organ Prolapse Quantification System (POP–Q) Stage 2 or 3
•3\.Women with a ring pessary due for checking or replacement
•The following criteria are relevant as the women most likely to benefit from the solution are those with these grades of prolapse, and the demographics most likely to suffer from POP are women above 50 years of age or post\-partum women

•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