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

ISRCTN ISRCTN08203457
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

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

Study designTwo-group single-blind feasibility study
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Scientific titleA two-group, single-blind, randomised controlled study to assess the feasibility of physiotherapy following surgery for prolapse to avoid recurrence
Study acronymSUPER
Study objectivesWomen 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) studiedPelvic organ prolapse
InterventionThe 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 typeBehavioural
Primary outcome measure1. 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 measures1. 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 date01/06/2010
Completion date31/05/2012

Eligibility

Participant type(s)Patient
Age groupAdult
SexFemale
Target number of participants30
Key inclusion criteriaWomen who undergo surgery for pelvic organ prolapse and are able to attend for pre and post operative follow-ups
Key exclusion criteriaWomen who have undergone individual Pelvic Floor Muscle Training (PFMT) during the previous 3 years or have undergone surgery for gynaecological cancer
Date of first enrolment01/06/2010
Date of final enrolment31/05/2012

Locations

Countries of recruitment

  • Scotland
  • United Kingdom

Study participating centre

Glasgow Caledonian University
Glasgow
G4 0BA
United Kingdom

Sponsor information

Physiotherapy Research Foundation (UK)
Charity

The Chartered Society of Physiotherapy
14 Bedford Row
London
WC1R 4ED
United Kingdom

Email attew@csp.org.uk
ROR logo "ROR" 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
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot 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