Condition category
Urological and Genital Diseases
Date applied
06/09/2005
Date assigned
12/09/2005
Last edited
21/10/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

http://www.gcal.ac.uk

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

  1. 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.

Additional files

Editorial Notes