Long Term Effect of Bariatric Surgery on Pelvic Floor Disorders

Weight Loss Clinical Trial

— ICONES  

Official title:

How Bariatric Surgery Impacts Pelvic Floor Disorders Evolution : Analysis on a Cohort From a French Hospital.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04575987
• Other study ID #: 2020-A02219-30
• Status: Recruiting
• Start date: December 14, 2020
• Est. completion date: June 14, 2021

Study information

• Verified date: January 2021
• Source: Poitiers University Hospital
• Contact: Océane CLERGUE
• Phone: 06.23.38.80.35
• Email: oceane.clergue[@]chu-poitiers.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Bariatric surgery is increasingly practiced, as it is the most efficient treatment for morbid obesity. More than eighty percent of the operated patients are women. Nethertheless, few is known about gynecologic long-term impact of such surgeries, especially regarding pelvic floor disorders (PFD). This work aims at studying the evolution of PFD in women following a bariatric surgery more than 18 months ago in a French university center Hospital.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 709
• Est. completion date: June 14, 2021
• Est. primary completion date: June 14, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

• Women,

• aged from 18 to 50 years old the day of their surgery,

• had a bariatric surgery in Poitiers university hospital center (France),

• are under french social security system.

Exclusion Criteria:

• to be under guardianship or tutelage measures

• to express opposition to participate to this study.

Related Conditions & MeSH terms

• Bariatric Surgery Candidate
• Pelvic Floor Disorders
• Weight Loss

Intervention

Other:
• Questionnaire
Questionnaires will be sent by email or by post, in which questions about PFD, obstetrical history or dietetic follow-up will be asked. Some obstetrical issues will be get from women medical files.

Locations

Country	Name	City	State
France	CHU de Poitiers	Poitiers

Sponsors (1)

Lead Sponsor	Collaborator
Poitiers University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prevalence of the main PFD	To evaluate the prevalence of the main PFD regarding the efficiency of the bariatric surgery 18 months or more after. The prevalence of PFD will be estimated thanks to the PFDI-20 questionnaire : urinary incontinence : at least one positive answer to questions 16 to 18 of PFDI-20; bowel incontinence : at least one positive answer to questions 8 to 10 of PFDI-20; vaginal prolapse : positive answer to question 3 of PFDI-20 Efficiency of the bariatric surgery will be estimated thanks to the weight registered in the medical file before bariatric surgery and the most recent weight obtained thanks to the questionnaire.; Our results will be adjusted for age, menopausal status, obstetrical and surgical history.	minimum 18 months after surgery