A feasibility study for an RCT of a pelvic floor muscle training intervention for pelvic organ prolapse

ISRCTN	ISRCTN44995705
DOI	https://doi.org/10.1186/ISRCTN44995705
ClinicalTrials.gov number	NCT00158626
Secondary identifying numbers	CZH/4/95; NRR N0470119684

Submission date: 06/09/2005
Registration date: 12/09/2005
Last edited: 21/10/2009

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Urological and Genital Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Suzanne Hagen
Scientific

NMAHP Reserach Unit
Govan Mbeki Health Building
Glasgow Caledonian University
City Campus
Cowcaddens Road
Glasgow
G4 0BA
United Kingdom

Phone	+44 (0)141 331 8104
Email	s.hagen@gcal.ac.uk

Study information

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
Scientific title
Study acronym	POPPY (Pelvic Organ Prolapse PhysiotherapY)
Study objectives	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(s)	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)
Health condition(s) or problem(s) studied	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
Primary outcome measure	Prolapse related symptoms and associated quality of life
Secondary outcome measures	POP-Q, days of symptoms, SF12
Overall study start date	22/09/2003
Completion date	31/08/2005

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Female
Target number of participants	50
Key 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
Key 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
Date of first enrolment	22/09/2003
Date of final enrolment	31/08/2005

Locations

Countries of recruitment

Scotland
United Kingdom

Study participating centre

NMAHP Reserach Unit

Glasgow
G4 0BA
United Kingdom

Sponsor information

Glasgow Caledonian University (UK)
University/education

c/o Professor Catherine Niven
NMAHP Reserach Unit
Govan Mbeki Health Building
Glasgow Caledonian University
City Campus
Cowcaddens Road
Glasgow
G4 0BA
Scotland
United Kingdom

Phone	+44 (0)141 331 8103
Email	k.niven@gcal.ac.uk
Website	http://www.gcal.ac.uk
"ROR"	https://ror.org/03dvm1235

Funders

Funder type

Government

Chief Scientist Office, Scottish Executive (UK) (ref: CZH/4/95)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/01/2009		Yes	No