Impact of Physiotherapy on sexual function in women with Stress Urinary Incontinence (SUI)

ISRCTN	ISRCTN09586238
DOI	https://doi.org/10.1186/ISRCTN09586238
Secondary identifying numbers	11623

Submission date: 03/05/2013
Registration date: 03/05/2013
Last edited: 19/10/2017

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 Swati Jha
Scientific

University of Sheffield
Academic Unit of Reproductive and Developmental Medicine
Level 4, Jessop Wing
Tree Root Walk
Sheffield
S10 2SF
United Kingdom

Phone	+44 (0)114 226 8166
Email	Swati.Jha@sth.nhs.uk

Study information

Study design	Randomised interventional trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details to request a patient information sheet
Scientific title	IPSU study: Impact of Physiotherapy on Sexual function in women with Stress Urinary Incontinence (SUI) and a comparison of electrical stimulation versus standard physiotherapy: a randomised controlled trial
Study acronym	IPSU
Study objectives	This study aims to evaluate the effect of physiotherapy on the sexual function in women with urinary incontinence. It also compares 2 different methods of pelvic floor muscle training comparing electrical stimulation to standard physiotherapy as a prospective parallel group randomised controlled trial (RCT). The clinical and cost effectiveness of these 2 interventions on the sexual function of women with urinary incontinence and the response to treatments over a 6-month period will be compared.
Ethics approval(s)	26/05/2011, ref: 11/YH/0170
Health condition(s) or problem(s) studied	Topic: Reproductive Health and Childbirth/Stress Urinary Incontinence
Intervention	Physiotherapy, 114 women (57 to each arm) will be randomly allocated to each treatment arm via the web based randomization procedure. Pelvic floor symptoms, including incontinence severity before and after treatment will be assessed using the Electronic Pelvic Floor Assessment Questionnaire (ePAQ). Changes in sexual function will be assessed using the Prolapse and Incontinence Sexual function Questionnaire (PISQ). SF-36 domain scores; EQ-5D score; ePAQ urinary & sexual domain scores before and after physiotherapy. Follow Up Length: 4 months Study Entry: Single Randomisation only Sample size estimation of the primary outcome will be the mean PISQ-31 physical dimension score at 6-months post randomisation. Responses to the items of the physical domain are on a 5 point ordinal scale from 0 (always) to 4 (never). Dimension scores are calculated by totaling the scores for each question. The 10-item physical dimension of the PISQ-31 is scored on a 0 to 40 scale with higher scores indicating better sexual functioning.
Intervention type	Other
Primary outcome measure	Physical dimension score (PISQ-31), at baseline and 6 months
Secondary outcome measures	1. PISQ-31 Behavioral Emotive dimension and Partner-Related dimension scores 2. SF-36 domain scores 3. EQ-5
Overall study start date	01/11/2011
Completion date	01/12/2013

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Upper age limit	60 Years
Sex	Female
Target number of participants	UK Sample Size: 114
Key inclusion criteria	1. Women aged 18-60 years must have given written (personally signed and dated) informed consent 2. Women who are able to understand, and are willing to comply with the requirements of the protocol 3. Women who are sexually active and are between the age of 18yrs and with urinary incontinence attending physiotherapy for pelvic floor muscle training (PFMT) 4. Women who score either greater than 25% on the urinary domain of the sexual function dimension, and/or greater than 33% for the degree of bother for the same symptom
Key exclusion criteria	1. Women with a prolapse as their predominant problem 2. Women who have had any previous incontinence surgery 3. Women who have a Grade 3 or above muscle strength as measured using the modified Oxford Scale on vaginal examination 4. Women with vaginal discharge or UTI 5. Women fitted with an implanted pacemaker 6. Women who are pregnant 7. Women with undiagnosed pelvic pain 8. Women with a known sensitivity to the electrodes or the electrode gel 9. Women with inflammation or infection of the vulva and vagina 10. Women who have experienced recent haemorrhage or haematoma 11. Women with atrophic vaginitis 12. Any other medical condition or abnormality (e.g. Malignancy or complication) that in the opinion of the investigator would impact upon the safety or efficacy of the study treatment or any study assessments 13. The patient is enrolled in another interventional trial 14. Non-English speaking women or with a specific language problem
Date of first enrolment	01/11/2011
Date of final enrolment	01/12/2013

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

University of Sheffield

Sheffield
S10 2SF
United Kingdom

Sponsor information

Sheffield Teaching Hospitals NHS Trust (UK)
Hospital/treatment centre

Royal Hallamshire Hospital
Glossop Road
Sheffield
S10 2JF
England
United Kingdom

Website	http://www.sth.nhs.uk/
"ROR"	https://ror.org/018hjpz25

Funders

Funder type

Government

National Institute for Health Research
Government organisation / National government

Alternative name(s): National Institute for Health Research, NIHR Research, NIHRresearch, NIHR - National Institute for Health Research, NIHR (The National Institute for Health and Care Research), NIHR
Location: United Kingdom

Results and Publications

Intention to publish date
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?
Results article	results	01/03/2018		Yes	No

Editorial Notes

19/10/2017: Publication reference added.