Continence After Vaginal Prolapse Surgery

Urinary Incontinence Clinical Trial

Official title:

Urinary Continence Status After Vaginal Surgery for Prolapse Correction.

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05312047
• Other study ID #: PR(AMI)631-2021
• Status: Active, not recruiting
• Start date: April 4, 2022
• Est. completion date: January 2025

Study information

• Verified date: May 2024
• Source: Hospital Universitari Vall d'Hebron Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 609
• Est. completion date: January 2025
• Est. primary completion date: January 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 99 Years

Eligibility

Inclusion Criteria:

• Women who will undergo vaginal surgery for pelvic organ prolapse.

Exclusion Criteria:

• Inability to give consent to the study.

Related Conditions & MeSH terms

• Enuresis
• Pelvic Organ Prolapse
• Prolapse
• Urinary Incontinence

Intervention

Procedure:
• Pelvic organ prolapse surgery
Vaginal surgery of any compartment for pelvic organ prolapse

Locations

Country	Name	City	State
Spain	Hospital Germans Trias i Pujol	Badalona	Barcelona
Spain	Hospital de Sant Pau	Barcelona
Spain	Hospital del Mar	Barcelona
Spain	Vall d'Hebron Barcelona Hospital Campus	Barcelona
Spain	Hospital Santa Caterina	Girona
Spain	Hospital General de Granollers	Granollers	Barcelona
Spain	Hospital General de l'Hospitalet	Hospitalet de Llobregat	Barcelona
Spain	Hospital d'Igualada	Igualada	Barcelona
Spain	Hospital Universitari de Bellvitge	L'Hospitalet De Llobregat	Barcelona
Spain	Parc Taulí Hospital Universitari	Sabadell	Barcelona
Spain	Hospital de l'Esperit Sant	Santa Coloma De Gramenet	Barcelona
Spain	Hospital Joan XXIII	Tarragona
Spain	Consorci Sanitari de Terrassa	Terrassa	Barcelona
Spain	Hospital de Viladecans	Viladecans	Barcelona

Sponsors (14)

Lead Sponsor

Collaborator

Hospital Universitari Vall d'Hebron Research Institute

Consorci Sanitari de Terrassa, Fundació Hospital de l'Esperit Sant, Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau, Germans Trias i Pujol Hospital, Hospital d'Igualada, Hospital de Granollers, Hospital de Mataró, Hospital de Viladecans, Hospital del Mar, Hospital Santa Caterina, Hospital Universitari de Bellvitge, Hospital Universitari Joan XXIII de Tarragona., Parc Taulí Hospital Universitari

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Stress urinary incontinence (SUI).	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) .	1 year after surgery.
Primary	Urgency urinary incontinence (UUI).	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".	1 year after surgery.
Secondary	Incontinence severity	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).	1 year after surgery.
Secondary	Patients' satisfaction with the procedure.	Assessed with the Patient Impression of Improvement (PGI-I) form.	1 year after surgery.