Impact of Physiotherapy on sexual function in women with Stress Urinary Incontinence (SUI)
| ISRCTN | ISRCTN09586238 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN09586238 |
| Protocol serial number | 11623 |
| Sponsor | Sheffield Teaching Hospitals NHS Trust (UK) |
| Funder | National Institute for Health Research |
- 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
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 |
|---|---|
| Swati.Jha@sth.nhs.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised interventional trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant 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(s) |
Physical dimension score (PISQ-31), at baseline and 6 months |
| Key secondary outcome measure(s) |
1. PISQ-31 Behavioral Emotive dimension and Partner-Related dimension scores |
| 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 sample size at registration | 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
- United Kingdom
- England
Study participating centre
University of Sheffield
Sheffield
S10 2SF
United Kingdom
S10 2SF
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 | 01/03/2018 | Yes | No | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
19/10/2017: Publication reference added.
