An intervention to improve prolapse using Femmeze® (v1)

• Research type

  Research Study

• Full title

  An intervention to improve the management of posterior vaginal compartment prolapse using Femmeze®: a feasibility study

• IRAS ID

  162694

• Contact name

  Sharon Eustice

• Contact email

  sharon.eustice@pch-cic.nhs.uk

• Clinicaltrials.gov Identifier

  NCT02280382

• Duration of Study in the UK

  0 years, 11 months, 30 days

• Research summary

  The main purpose of the feasibility study is to identify the patient experience of Femmeze® which is a class 1 medical device aimed at improving posterior vaginal compartment prolapse (rectocele) for women with obstructive defaecation. We want to investigate implementation and preliminary effectiveness of the device. The method of investigation will be a pre-post intervention design, which involves asking 30 women recruited from Royal Cornwall Hospitals to use Femmeze® over a period of 8 weeks.

• REC name

  South West - Cornwall & Plymouth Research Ethics Committee

• REC reference

  15/SW/0107

• Date of REC Opinion

  1 Jun 2015

• REC opinion

  Further Information Favourable Opinion