|
ISRCTN
|
ISRCTN44995705
|
|
ClinicalTrials.gov identifier
|
NCT00158626
|
|
Public title
|
A feasibility study for an RCT of a pelvic floor muscle training intervention for pelvic organ prolapse
|
|
Scientific title
|
|
|
Acronym
|
POPPY (Pelvic Organ Prolapse PhysiotherapY)
|
|
Serial number at source
|
CZH/4/95; NRR N0470119684
|
|
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
|
|
Lay summary
|
|
|
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
|
|
Countries of recruitment
|
United Kingdom
|
|
Disease/condition/study domain
|
Pelvic organ prolapse
|
|
Participants - 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
|
|
Participants - 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
|
|
Anticipated start date
|
22/09/2003
|
|
Anticipated end date
|
31/08/2005
|
|
Status of trial
|
Completed |
|
Patient information material
|
Not available in web format, please use the contact details below to request a patient information sheet
|
|
Target number of participants
|
50
|
|
Interventions
|
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.
|
|
Primary outcome measure(s)
|
Prolapse related symptoms and associated quality of life
|
|
Secondary outcome measure(s)
|
POP-Q, days of symptoms, SF12
|
|
Sources of funding
|
Chief Scientist Office, Scottish Executive (UK) (ref: CZH/4/95)
|
|
Trial website
|
|
|
Publications
|
2009 results in http://www.ncbi.nlm.nih.gov/pubmed/18806910
|
|
Contact name
|
Prof
Suzanne
Hagen
|
|
Address
|
NMAHP Reserach Unit
Govan Mbeki Health Building
Glasgow Caledonian University
City Campus
Cowcaddens Road
|
|
City/town
|
Glasgow
|
|
Zip/Postcode
|
G4 0BA
|
|
Country
|
United Kingdom
|
|
Tel
|
+44 (0)141 331 8104
|
|
Fax
|
+44 (0)141 331 8101
|
|
Email
|
s.hagen@gcal.ac.uk
|
|
Sponsor
|
Glasgow Caledonian University (UK)
|
|
Address
|
c/o Professor Catherine Niven
NMAHP Reserach Unit
Govan Mbeki Health Building
Glasgow Caledonian University
City Campus
Cowcaddens Road
|
|
City/town
|
Glasgow
|
|
Zip/Postcode
|
G4 0BA
|
|
Country
|
United Kingdom
|
|
Tel
|
+44 (0)141 331 8103
|
|
Email
|
k.niven@gcal.ac.uk
|
|
Sponsor website:
|
http://www.gcal.ac.uk
|
|
Date applied
|
06/09/2005
|
|
Last edited
|
21/10/2009
|
|
Date ISRCTN assigned
|
12/09/2005
|
