Contact information
Type
Scientific
Primary contact
Prof Suzanne Hagen
ORCID ID
Contact details
NMAHP Reserach Unit
Govan Mbeki Health Building
Glasgow Caledonian University
City Campus
Cowcaddens Road
Glasgow
G4 0BA
United Kingdom
+44 (0)141 331 8104
s.hagen@gcal.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
NCT00158626
Protocol/serial number
CZH/4/95; NRR N0470119684
Study information
Scientific title
Acronym
POPPY (Pelvic Organ Prolapse PhysiotherapY)
Study hypothesis
To address the feasibility of undertaking a multi-centre randomised controlled trial of the effectiveness of a pelvic floor muscle training (PFMT) intervention for women with pelvic organ prolapse. The feasibility of all aspects of such a trial will be assessed, and pilot data will be collected which will allow sample size calculations to be refined. Ultimately, a multi-centred trial would aim to establish if PFMT is better than standardised management for reducing prolapse specific symptoms, prolapse severity, the need for surgical prolapse repair and the costs associated with the condition.
Added 21/10/09:
This feasibility study lead to a full trial, details may be viewed at
http://www.controlled-trials.com/ISRCTN35911035
Ethics approval
Added 07/10/09:
1. Southern General Hospital Ethics Committee approved 25 September 2002 (ref: EC/02/S/115)
2. Grampian Research Ethics Committee approved 11 March 2003 (ref: 02/0243)
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Pelvic organ prolapse
Intervention
Intervention arm:
Women receive an individualised programme of PFMT delivered by a physiotherapist via 5 sessions of physiotherapy over a 16 week period. This programme includes pelvic muscle assessment, teaching, prescription of pelvic floor exercises and lifestyle advice.
Control arm:
Women receive an information leaflet containing lifestyle advice.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
Prolapse related symptoms and associated quality of life
Secondary outcome measures
POP-Q, days of symptoms, SF12
Overall trial start date
22/09/2003
Overall trial end date
31/08/2005
Reason abandoned
Eligibility
Participant inclusion criteria
Women with previously untreated stage I or stage II pelvic organ prolapse attending gynaecology, urogynaecology and prolapse specific out-patient clinics at South Glasgow University Hospitals NHS Trust and Grampian University Hospitals NHS Trust
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
50
Participant exclusion criteria
Women who have had previous surgical or conservative treatment for prolapse (e.g. pessary management or previous pelvic floor muscle training) or women not considered suitable for physiotherapy treatment
Recruitment start date
22/09/2003
Recruitment end date
31/08/2005
Locations
Countries of recruitment
United Kingdom
Trial participating centre
NMAHP Reserach Unit
Glasgow
G4 0BA
United Kingdom
Sponsor information
Organisation
Glasgow Caledonian University (UK)
Sponsor details
c/o Professor Catherine Niven
NMAHP Reserach Unit
Govan Mbeki Health Building
Glasgow Caledonian University
City Campus
Cowcaddens Road
Glasgow
G4 0BA
United Kingdom
+44 (0)141 331 8103
k.niven@gcal.ac.uk
Sponsor type
University/education
Website
Funders
Funder type
Government
Funder name
Chief Scientist Office, Scottish Executive (UK) (ref: CZH/4/95)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
2009 results in http://www.ncbi.nlm.nih.gov/pubmed/18806910
Publication citations
-
Results
Hagen S, Stark D, Glazener C, Sinclair L, Ramsay I, A randomized controlled trial of pelvic floor muscle training for stages I and II pelvic organ prolapse., Int Urogynecol J Pelvic Floor Dysfunct, 2009, 20, 1, 45-51, doi: 10.1007/s00192-008-0726-4.