Contact information
Type
Scientific
Primary contact
Dr Doreen McClurg
ORCID ID
Contact details
Nursing
Midwifery and Allied Health Professions Research Unit
Glasgow Caledonian University
Buchanan House
Cowcaddens Road
Glasgow
G4 0BA
United Kingdom
+44 (0)141 331 8105
doreen.mcclurg@gcu.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
PRF/09/1
Study information
Scientific title
A two-group, single-blind, randomised controlled study to assess the feasibility of physiotherapy following surgery for prolapse to avoid recurrence
Acronym
SUPER
Study hypothesis
Women who undergo physiotherapy intervention following surgery for pelvic organ prolapse have short and long term symptom benefit when compared to those who do not have such an additional intervention
Ethics approval
Under application
Study design
Two-group single-blind feasibility study
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Pelvic organ prolapse
Intervention
The control group will receive a lifestyle advice only
The treatment group will receive one pre-operative appointment, one post-operative appointment on the ward, followed by 6 appointments with a physiotherapist to encourage pelvic floor muscle training. Home exercises and lifestyle advice will also be provided.
Intervention type
Behavioural
Phase
Drug names
Primary outcome measures
1. Pelvic organ prolapse symptom score
2. Organ prolapse quantification system
All outcome measures will be completed pre-intervention and 6 and 12 months post-intervention
Secondary outcome measures
1. Incontinence Questionnaire Short Form (ICIQ-SF)
2. Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-12)
3. Digital assessment of pelvic floor muscles
4. SF-12
All outcome measures will be completed pre-intervention and 6 and 12 months post-intervention
Overall trial start date
01/06/2010
Overall trial end date
31/05/2012
Reason abandoned
Eligibility
Participant inclusion criteria
Women who undergo surgery for pelvic organ prolapse and are able to attend for pre and post operative follow-ups
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
30
Participant exclusion criteria
Women who have undergone individual Pelvic Floor Muscle Training (PFMT) during the previous 3 years or have undergone surgery for gynaecological cancer
Recruitment start date
01/06/2010
Recruitment end date
31/05/2012
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Glasgow Caledonian University
Glasgow
G4 0BA
United Kingdom
Sponsor information
Organisation
Physiotherapy Research Foundation (UK)
Sponsor details
The Chartered Society of Physiotherapy
14 Bedford Row
London
WC1R 4ED
United Kingdom
-
attew@csp.org.uk
Sponsor type
Charity
Website
Funders
Funder type
Charity
Funder name
Physiotherapy Research Foundation (UK) (ref: PRF/09/1)
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
2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/24500453