Urinary Incontinence Clinical Trial
Official title:
A Prospective Study of the Impact of Abdominoplasty on the Symptoms of Back Pain and Urinary Incontinence in the Post Partum Population.
The study investigates the impact of abdominoplasty in the post partum population on the symptoms of back pain and urinary incontinence. Patients presenting for abdominoplasty fill out validated questionnaires for both back pain (Oswestry Disability Index) and urinary incontinence (ICIQ-UI short form). They complete the same questionnaires 6 weeks and 6 months post op. The prospectively gathered data gives an insight into the incidence of functional symptoms in this post partum group preop as well as the degree of improvement gained postop. This is a multicenter trial with 9 surgeons submitting patients to the study, which ran for 19 months.
Abdominoplasty has long been considered a cosmetic procedure, improving the shape of the
abdomen by excess skin removal, liposuction and rectus muscle plication. Performed chiefly
on the post-partum and weight loss population, there have been reports of improvement in the
functional symptoms of back pain and incontinence following abdominoplasty with rectus
plication but there has been no prospective multicentre study to investigate the issue.
The incidence of chronic back pain greater than two years following pregnancy has been
reported between 5% to 21.1%. Persistent urinary incontinence rates 10 to 12 years after
pregnancy range between 25% to 37.9%. Vaginal delivery is associated with a higher incidence
of long term stress incontinence. The Australian female population is approximately 11m.
With a 24% rate of childlessness up to 1.67m Australian women are suffering chronic back
pain and 3.2m stress incontinence. Both these conditions negatively affect the quality of
life and are usually under reported.
This is a multicentre prospective study on the impact of abdominoplasty on back pain and
urinary incontinence in the post-partum population. All post-partum patients presenting for
abdominoplasty were enrolled to give an indication of incidence of symptoms in this
population as well as the magnitude of improvement or deterioration.
The prospective study utilised validated questionnaires. For back pain the Oswestry
Disability Index (ODI) was selected as it is an excellent measure of a patient's functional
disability and has been in use for nearly 40 years. The Index is a multiple choice
questionnaire, divided into 10 sections assessing Pain Intensity, Personal Care, Lifting,
Walking, Sitting, Standing, Sleeping, Social Life, Travelling and the impact on Employment
and House making. Each section is scored from 0 to 5, the maximum score is 50. The score is
then doubled to become a percentage disability index. Urinary Incontinence was measured with
the International Consultation On Incontinence Questionnaire - Urinary Incontinence - Short
Form (ICIQ-UI-SF). This is also a multiple-choice questionnaire asking the patient to score
the frequency of urine leakage, how much they think leaks and on a scale of one to ten how
much it interferes with daily life. It is not a disability index like the Oswestry. A
maximum score is 21 with urine leaking all the time, large amounts and interfering with life
a great deal.
Patients completed the questionnaires pre abdominoplasty and at 6 weeks and 6 months post
operation. Demographic information was collected; Age, Parity, Age Range of Children (the
years between the oldest and youngest), Method of Birth (Vaginal or Caesarean) and BMI
preoperatively. Surgical data was also obtained; Method of Abdominoplasty, Weight Removed,
Volume of Liposuction, Width of Diastasis and the presence of a Hernia. No data on
postoperative complications was collected. Patients signed an informed consent form to
participate after reading an information pamphlet and the study was approved by the ACT
Health Human Research Ethics Committee.
A presentation at the 37th Annual Australasian Society of Aesthetic Plastic Surgeons
conference in August 2014 recruited surgeons to the study. Nine surgeons agreed to take part
and were given packs of questionnaires, patient information brochures, consent forms,
demographic forms and a surgeons information sheet. The nine participants were individual
private practitioners, four from Sydney NSW and one each from Canberra ACT, Toowoomba QLD,
Brisbane QLD, Gold Coast QLD and Newcastle NSW, a mix of capital city and smaller regional
centres along the east coast of Australia.
The objective was to study both the incidence of functional symptoms in the population
presenting for abdominoplasty as well as the outcome. Study surgeons were instructed to
enrol all post-partum abdominoplasty patients. Nulliparous weight loss patients were
excluded as were males. The completed forms were posted back to the study author who
compiled the results. Statistical analysis was performed by Datalytics (Bruce ACT).
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