Surgery and physiotherapy for prolapse to avoid recurrence: a feasibility study

ISRCTN	ISRCTN08203457
DOI	https://doi.org/10.1186/ISRCTN08203457
Protocol serial number	PRF/09/1
Sponsor	Physiotherapy Research Foundation (UK)
Funder	Physiotherapy Research Foundation (UK) (ref: 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

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
Email	doreen.mcclurg@gcu.ac.uk

Study information

Primary study design	Interventional
Study design	Two-group single-blind feasibility study
Secondary study design	Randomised controlled trial
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(s)	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
Key secondary outcome measure(s)	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
Completion date	31/05/2012

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Female
Target sample size at registration	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

United Kingdom
Scotland

Study participating centre

Glasgow Caledonian University

Glasgow
G4 0BA
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	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	01/07/2014		Yes	No