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.
Verified date | May 2017 |
Source | The Caps Clinic |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 214 |
Est. completion date | September 30, 2016 |
Est. primary completion date | March 31, 2016 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 16 Years to 70 Years |
Eligibility |
Inclusion Criteria: - Post Partum Females presenting for abdominoplasty Exclusion Criteria: - Males and non post partum females presenting for abdominoplasty |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
The Caps Clinic |
7. Australian Bureau of Statistics 2000, Births, Australia, 2000, cat no. 3301.0, ABS, Canberra
Altman D, Ekström A, Gustafsson C, López A, Falconer C, Zetterström J. Risk of urinary incontinence after childbirth: a 10-year prospective cohort study. Obstet Gynecol. 2006 Oct;108(4):873-8. — View Citation
Davidson M, Keating JL. A comparison of five low back disability questionnaires: reliability and responsiveness. Phys Ther. 2002 Jan;82(1):8-24. — View Citation
Fairbank JC, Pynsent PB. The Oswestry Disability Index. Spine (Phila Pa 1976). 2000 Nov 15;25(22):2940-52; discussion 2952. Review. — View Citation
MacArthur C, Wilson D, Herbison P, Lancashire RJ, Hagen S, Toozs-Hobson P, Dean N, Glazener C; Prolong study group.. Urinary incontinence persisting after childbirth: extent, delivery history, and effects in a 12-year longitudinal cohort study. BJOG. 2016 May;123(6):1022-9. doi: 10.1111/1471-0528.13395. Epub 2015 Apr 2. — View Citation
Norén L, Ostgaard S, Johansson G, Ostgaard HC. Lumbar back and posterior pelvic pain during pregnancy: a 3-year follow-up. Eur Spine J. 2002 Jun;11(3):267-71. Epub 2001 Dec 8. — View Citation
Ostgaard HC, Zetherström G, Roos-Hansson E. Back pain in relation to pregnancy: a 6-year follow-up. Spine (Phila Pa 1976). 1997 Dec 15;22(24):2945-50. — View Citation
Timmermans L, Falez F, Mélot C, Wespes E. Validation of use of the International Consultation on Incontinence Questionnaire-Urinary Incontinence-Short Form (ICIQ-UI-SF) for impairment rating: a transversal retrospective study of 120 patients. Neurourol Urodyn. 2013 Sep;32(7):974-9. doi: 10.1002/nau.22363. Epub 2012 Dec 31. — View Citation
To WW, Wong MW. Factors associated with back pain symptoms in pregnancy and the persistence of pain 2 years after pregnancy. Acta Obstet Gynecol Scand. 2003 Dec;82(12):1086-91. — View Citation
Viktrup L, Rortveit G, Lose G. Risk of stress urinary incontinence twelve years after the first pregnancy and delivery. Obstet Gynecol. 2006 Aug;108(2):248-54. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Back pain | Reduction in back pain following abdominoplasty measured by questionnaire | 6 months | |
Primary | Urinary incontinence | reduction in urinary incontinence following abdominoplasty measured by questionnaire | 6 months |
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