Topic: Reproductive Health and Childbirth/Stress Urinary Incontinence Urological and Genital Diseases
Conditions
Interventions
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
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
Sponsors
Sheffield Teaching Hospitals NHS Trust (UK)
Eligibility
Sex/Gender
Female
Inclusion criteria
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
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Physical dimension score (PISQ-31), at baseline and 6 months | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. PISQ-31 Behavioral Emotive dimension and Partner-Related dimension scores 2. SF-36 domain scores 3. EQ-5 | — |
Countries
United Kingdom
Outcome results
None listed