Condition category
Urological and Genital Diseases
Date applied
01/06/2010
Date assigned
02/08/2010
Last edited
02/06/2015
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

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

Publication citations

Additional files

Editorial Notes