Condition category
Urological and Genital Diseases
Date applied
03/05/2013
Date assigned
03/05/2013
Last edited
09/06/2016
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 Swati Jha

ORCID ID

Contact details

University of Sheffield
Academic Unit of Reproductive and Developmental Medicine
Level 4
Jessop Wing
Tree Root Walk
Sheffield
S10 2SF
United Kingdom
+44 114 226 8166
Swati.Jha@sth.nhs.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

11623

Study information

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

Acronym

IPSU

Study hypothesis

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

26/05/2011, ref: 11/YH/0170

Study design

Randomised interventional trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

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

Phase

Not Applicable

Drug names

Primary outcome measures

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 trial start date

01/11/2011

Overall trial end date

01/12/2013

Reason abandoned

Eligibility

Participant 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.

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

UK Sample Size: 114

Participant 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.

Recruitment start date

01/11/2011

Recruitment end date

01/12/2013

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Academic Unit of Reproductive and Developmental Medicine
Sheffield
S10 2SF
United Kingdom

Sponsor information

Organisation

Sheffield Teaching Hospitals NHS Trust (UK)

Sponsor details

Royal Hallamshire Hospital
Glossop Road
Sheffield
S10 2JF
United Kingdom

Sponsor type

Hospital/treatment centre

Website

http://www.sth.nhs.uk/

Funders

Funder type

Government

Funder name

National Institute for Health Research

Alternative name(s)

NIHR

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

Location

United Kingdom

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

Publication citations

Additional files

Editorial Notes

09/06/2016: No publications found, verifying study status with principal investigator.