Continence After Vaginal Prolapse Surgery

Sponsor

Hospital Universitari Vall d'Hebron Research Institute (Other)

Overall Status

Recruiting

CT.gov ID

NCT05312047

Collaborator

Consorci Sanitari de Terrassa (Other)

600

Enrollment

Locations

24.9

Anticipated Duration (Months)

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Urinary incontinence after surgical correction of pelvic organ prolapse (POP) could occur. This is a condition that decreases both patients' satisfaction and quality of life. Reports on the prevalence of urinary incontinence after POP surgery are controversial. Concomitant surgery for incontinence could reduce this prevalence, whereas it increases treatment costs and the likelihood of surgical complications. Therefore, it is of paramount importance to know the exact prevalence of urinary incontinence after POP surgery in our population and the potential risk factors associated with this condition.

Condition or Disease	Intervention/Treatment	Phase
Pelvic Organ Prolapse Urinary Incontinence	Procedure: Pelvic organ prolapse surgery

Study Design

Study Type:

Observational

Anticipated Enrollment :

600 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Urinary Continence Status After Vaginal Surgery for Prolapse Correction.

Actual Study Start Date :

Apr 4, 2022

Anticipated Primary Completion Date :

May 1, 2024

Anticipated Study Completion Date :

May 1, 2024

Outcome Measures

Primary Outcome Measures

Stress urinary incontinence (SUI). [1 year after surgery.]
A "Yes" response to any of three questions on the spanish version of the Pelvic Floor Distress Inventory (PFDI) stress incontinence subscale regarding leakage with coughing, sneezing, or laughing; physical exercise; and lifting or bending over (PFDI questions 20, 21 and 22) .
Urgency urinary incontinence (UUI). [1 year after surgery.]
A "Yes" response to PFDI question 19, "usually experiences urine leakage associated with a feeling of urgency, that is, a strong sensation of needing to go to the bathroom".

Secondary Outcome Measures

Incontinence severity [1 year after surgery.]
Both SUI and UII severity will be assessed using the spanish versions of the Sandvik's severity index and the International Consultation on Incontinence Questionnaire Short Form (ICIQ-SF).
Patients' satisfaction with the procedure. [1 year after surgery.]
Assessed with the Patient Impression of Improvement (PGI-I) form.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 99 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Inclusion Criteria:

Women who will undergo vaginal surgery for pelvic organ prolapse.

Exclusion Criteria:

Inability to give consent to the study.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hospital Germans Trias i Pujol	Badalona	Barcelona	Spain
2	Hospital General de Granollers	Granollers	Barcelona	Spain
3	Hospital d'Igualada	Igualada	Barcelona	Spain
4	Hospital Universitari de Bellvitge	L'Hospitalet De Llobregat	Barcelona	Spain
5	Hospital de l'Esperit Sant	Santa Coloma De Gramenet	Barcelona	Spain
6	Consorci Sanitari de Terrassa	Terrassa	Barcelona	Spain
7	Hospital de Viladecans	Viladecans	Barcelona	Spain
8	Vall d'Hebron Barcelona Hospital Campus	Barcelona		Spain	08035

Sponsors and Collaborators

Hospital Universitari Vall d'Hebron Research Institute
Consorci Sanitari de Terrassa

Investigators

Principal Investigator: Marina Catalan, MD, Vall d'Hebron Barcelona Hospital Campus
Study Director: Jordi Sabadell, MD, Vall d'Hebron Barcelona Hospital Campus