Continence After Vaginal Prolapse Surgery

Active, not recruiting

• Conditions: Pelvic Organ Prolapse; Urinary Incontinence

• Registration Number: NCT05312047
• Lead Sponsor: Hospital Universitari Vall d'Hebron Research Institute

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-03-17
• Study First Submitted QC: 2022-03-28
• Study Start: 2022-04-04
• Study First Posted: 2022-04-05
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-09
• Last Update Posted: 2024-05-10
• Primary Completion: 2025-01
• Study Completion: 2025-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Female
• Target Recruitment: 609

Inclusion Criteria

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

Exclusion Criteria

• Inability to give consent to the study.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.

Trial Locations

Locations (14)

Hospital de Sant Pau; 🇪🇸 Barcelona, Spain

Hospital Santa Caterina; 🇪🇸 Girona, Spain

Parc Taulí Hospital Universitari; 🇪🇸 Sabadell, Barcelona, Spain

Hospital Germans Trias i Pujol; 🇪🇸 Badalona, Barcelona, Spain

Hospital del Mar; 🇪🇸 Barcelona, Spain

Hospital Joan XXIII; 🇪🇸 Tarragona, Spain

Consorci Sanitari de Terrassa; 🇪🇸 Terrassa, Barcelona, Spain

Vall d'Hebron Barcelona Hospital Campus; 🇪🇸 Barcelona, Spain

Hospital de Viladecans; 🇪🇸 Viladecans, Barcelona, Spain

Hospital General de l'Hospitalet; 🇪🇸 Hospitalet de Llobregat, Barcelona, Spain

Hospital General de Granollers; 🇪🇸 Granollers, Barcelona, Spain

Hospital d'Igualada; 🇪🇸 Igualada, Barcelona, Spain

Hospital Universitari de Bellvitge; 🇪🇸 L'Hospitalet De Llobregat, Barcelona, Spain

Hospital de l'Esperit Sant; 🇪🇸 Santa Coloma De Gramenet, Barcelona, Spain