Functional Improvement With Abdominoplasty

NCT03143959 | Completed

• 1 other identifier: FuncAbdo
• Study Type: observational
• Target: 214
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Lower Back Pain Chronic; Urinary Incontinence; Recti Diastasis; Abdominoplasty

Outcome Measures

Primary Outcomes (2)

• Back pain

  Reduction in back pain following abdominoplasty measured by questionnaire

  6 months

• Urinary incontinence

  reduction in urinary incontinence following abdominoplasty measured by questionnaire

  6 months

Eligibility Criteria

• Age: 16 Years - 70 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Any post partum female presenting for abominoplasty regardless of whether they have functional symptoms or not.

You may qualify if:

• Post Partum Females presenting for abdominoplasty

You may not qualify if:

• Males and non post partum females presenting for abdominoplasty

Sponsors & Collaborators

• The Caps Clinic: lead

Related Publications (10)

• Noren 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. doi: 10.1007/s00586-001-0357-7. Epub 2001 Dec 8.

  PMID: 12107796 BACKGROUND

• Ostgaard HC, Zetherstrom 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. doi: 10.1097/00007632-199712150-00018.

  PMID: 9431631 BACKGROUND

• 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. doi: 10.1046/j.1600-0412.2003.00235.x.

  PMID: 14616251 BACKGROUND

• Altman D, Ekstrom A, Gustafsson C, Lopez A, Falconer C, Zetterstrom J. Risk of urinary incontinence after childbirth: a 10-year prospective cohort study. Obstet Gynecol. 2006 Oct;108(4):873-8. doi: 10.1097/01.AOG.0000233172.96153.ad.

  PMID: 17012448 BACKGROUND

• 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. doi: 10.1097/01.AOG.0000226860.01127.0e.

  PMID: 16880292 BACKGROUND

• 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.

  PMID: 25846816 BACKGROUND

• 7. Australian Bureau of Statistics 2000, Births, Australia, 2000, cat no. 3301.0, ABS, Canberra

  BACKGROUND

• Fairbank JC, Pynsent PB. The Oswestry Disability Index. Spine (Phila Pa 1976). 2000 Nov 15;25(22):2940-52; discussion 2952. doi: 10.1097/00007632-200011150-00017.

  PMID: 11074683 BACKGROUND

• Davidson M, Keating JL. A comparison of five low back disability questionnaires: reliability and responsiveness. Phys Ther. 2002 Jan;82(1):8-24. doi: 10.1093/ptj/82.1.8.

  PMID: 11784274 BACKGROUND

• Timmermans L, Falez F, Melot 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.

  PMID: 23281067 BACKGROUND

MeSH Terms

Conditions

Urinary Incontinence

Condition Hierarchy (Ancestors)

Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Alastair Taylor, FRACS

  The Caps Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Plastic Surgeon

Study Record Dates

• First Submitted: May 4, 2017
• First Posted: May 8, 2017
• Study Start: September 1, 2014
• Primary Completion: March 31, 2016
• Study Completion: September 30, 2016
• Last Updated: May 9, 2017

Record last verified: 2017-05

Data Sharing

• IPD Sharing: Will not share