Surgery and physiotherapy for prolapse to avoid recurrence: a feasibility study
ISRCTN | ISRCTN08203457 |
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DOI | https://doi.org/10.1186/ISRCTN08203457 |
Secondary identifying numbers | PRF/09/1 |
- Submission date
- 01/06/2010
- Registration date
- 02/08/2010
- Last edited
- 02/06/2015
- 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
Dr Doreen McClurg
Scientific
Scientific
Nursing, Midwifery and Allied Health Professions Research Unit
Glasgow Caledonian University
Buchanan House
Cowcaddens Road
Glasgow
G4 0BA
United Kingdom
Phone | +44 (0)141 331 8105 |
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doreen.mcclurg@gcu.ac.uk |
Study information
Study design | Two-group single-blind feasibility study |
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Primary study design | Interventional |
Secondary study design | Randomised controlled trial |
Study setting(s) | Hospital |
Study type | Treatment |
Scientific title | A two-group, single-blind, randomised controlled study to assess the feasibility of physiotherapy following surgery for prolapse to avoid recurrence |
Study acronym | SUPER |
Study objectives | 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(s) | Under application |
Health condition(s) or problem(s) studied | 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 |
Primary outcome measure | 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 study start date | 01/06/2010 |
Completion date | 31/05/2012 |
Eligibility
Participant type(s) | Patient |
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Age group | Adult |
Sex | Female |
Target number of participants | 30 |
Key inclusion criteria | Women who undergo surgery for pelvic organ prolapse and are able to attend for pre and post operative follow-ups |
Key exclusion criteria | Women who have undergone individual Pelvic Floor Muscle Training (PFMT) during the previous 3 years or have undergone surgery for gynaecological cancer |
Date of first enrolment | 01/06/2010 |
Date of final enrolment | 31/05/2012 |
Locations
Countries of recruitment
- Scotland
- United Kingdom
Study participating centre
Glasgow Caledonian University
Glasgow
G4 0BA
United Kingdom
G4 0BA
United Kingdom
Sponsor information
Physiotherapy Research Foundation (UK)
Charity
Charity
The Chartered Society of Physiotherapy
14 Bedford Row
London
WC1R 4ED
United Kingdom
attew@csp.org.uk | |
https://ror.org/04sn78z72 |
Funders
Funder type
Charity
Physiotherapy Research Foundation (UK) (ref: PRF/09/1)
No information available
Results and Publications
Intention to publish date | |
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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? |
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Results article | results | 01/07/2014 | Yes | No |