Development of a novel intravaginal device for rehabilitating women with pelvic organ prolapse.

Not Applicable

• Conditions: Pelvic organ prolapse; Physical Medicine / Rehabilitation - Other physical medicine / rehabilitation; Renal and Urogenital - Other renal and urogenital disorders

• Registration Number: ACTRN12623000134628
• Lead Sponsor: Monash University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-02-08
• Last Update Posted: 13 February 2023

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: Female
• Target Recruitment: 10

Inclusion Criteria

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.

Exclusion Criteria

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified