Status:
COMPLETED
PEssary Plus Physiotherapy for Pelvic Organ Prolapse (PEPPY)
Lead Sponsor:
Glasgow Caledonian University
Collaborating Sponsors:
NHS Greater Glasgow and Clyde
Conditions:
Pelvic Organ Prolapse
Eligibility:
FEMALE
16+ years
Phase:
NA
Brief Summary
1. To determine the feasibility of conducting a randomised controlled trial (RCT) of the effectiveness of a PFMT intervention in conjunction with vaginal pessary management versus vaginal pessary mana...
Detailed Description
It is hypothesised that undertaking PFMT with a pessary in place may increase the level of existing muscle support in the pelvic area: by reducing the descent of the pelvic organs and the consequent s...
Eligibility Criteria
Inclusion
- Women:
- who are new attendees at outpatient gynaecology clinics with a primary complaint of prolapse;
- who have a prolapse of stage I to IV confirmed by their gynaecologist using the POP-Q grading system;
- who have a prolapse of one or more of the following types:
- anterior vaginal wall prolapse (urethrocele, cystocele,paravaginal defect);
- uterine/cervical prolapse;
- vaginal vault (after hysterectomy)prolapse;
- posterior vaginal wall prolapse (enterocele, rectocele, perineal deficiency);
- who require a vaginal pessary for treatment of their prolapse (the process of fitting the pessary will be according to standard practice at the centre thus the protocol for choice of pessary, insertion and follow-up will be determined locally);
- who successfully retain the vaginal pessary for two weeks after fitting;
- who are willing to participate in the study and to comply with their group allocation.
Exclusion
- Women:
- who wish surgical treatment for prolapse and wish to be immediately added to the surgical waiting list;
- who have had previous surgical treatment for prolapse;
- who have had a pessary fitted for treatment of prolapse within the last 12 months;
- who have had previous formal instruction in PFMT;
- who present with contraindications to either pessary or PFMT treatment;
- who are unable to comply with PFMT treatment;
- who have local atrophy (this must be treated first);
- who are less than 6-months postnatal;
- who are pregnant;
- who are unable to give informed consent.
Key Trial Info
Start Date :
April 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2010
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT01136889
Start Date
April 1 2008
End Date
December 1 2010
Last Update
January 19 2011
Active Locations (4)
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1
Aberdeen Royal Infirmary
Aberdeen, United Kingdom
2
Falkirk and District Royal Infirmary
Falkirk, United Kingdom
3
Southern General Hospital
Glasgow, United Kingdom
4
Victoria Infirmary
Glasgow, United Kingdom