NCT02331186

Brief Summary

Urinary incontinence is well documented as a comorbidity of obesity. Studies demonstrate improvement of incontinency after weight loss. However, the mechanisms are still not clear. Aim of our study to analyze the effects of bariatric surgery on pelvic floor function in women.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Dec 2014

Shorter than P25 for all trials

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2014

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

December 21, 2014

Completed
16 days until next milestone

First Posted

Study publicly available on registry

January 6, 2015

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

January 6, 2015

Status Verified

January 1, 2015

Enrollment Period

1 year

First QC Date

December 21, 2014

Last Update Submit

January 2, 2015

Conditions

Urinary IncontinenceObesity

Keywords

ObesityBariatric surgeryUrinary incontinencePelvic floor

Outcome Measures

Primary Outcomes (1)

  • urodynamic parameters

    effect of bariatric surgery on urodynamic parameters in obese women

    after six month

Secondary Outcomes (3)

  • Urinary incontinence

    after six month

  • oxford scales

    after six month

  • health quality scores

    after six month

Study Arms (1)

obese women who underwent bariatric surgery

obese women who underwent bariatric surgery

Procedure: bariatric surgery

Interventions

bariatric surgeryPROCEDURE

bariatric surgery for obese women

obese women who underwent bariatric surgery

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

women who underwent bariatric surgery Body mass index ≥ 40 kg/m2 \>18 years old

You may qualify if:

  • Body mass index ≥ 40 kg/m2
  • \>18 years old
  • participants who provided written informed consent

You may not qualify if:

  • History of gynecologic operation time under one year
  • History of pelvic physiotherapy
  • Chronic obstructif lung disease
  • Norologic disease
  • Women in menopause

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Bakirkoy Dr Sadi Konuk Training and Research Hospital

Istanbul, Bakirkoy, 34140, Turkey (Türkiye)

RECRUITING

Bakirkoy Dr. Sadi Konuk Teaching and Research Hospital

Istanbul, Istanbul, 34147, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Urinary IncontinenceObesity

Interventions

Bariatric Surgery

Condition Hierarchy (Ancestors)

Urination DisordersUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesLower Urinary Tract SymptomsUrological ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody Weight

Intervention Hierarchy (Ancestors)

BariatricsObesity ManagementTherapeuticsSurgical Procedures, Operative

Central Study Contacts

hediye dağdeviren

CONTACT

05536161385hediyedagdeviren@gmail.com

huseyin cengiz, MD

CONTACT

05325950454obstetrik@gmail.com

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
M.D.

Study Record Dates

First Submitted

December 21, 2014

First Posted

January 6, 2015

Study Start

December 1, 2014

Primary Completion

December 1, 2015

Study Completion

December 1, 2015

Last Updated

January 6, 2015

Record last verified: 2015-01

Locations

TU(2)