Clinical trial NCT05312047: Continence After Vaginal Prolapse Surgery
Official title: Urinary Continence Status After Vaginal Surgery for Prolapse Correction.
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Pelvic Organ Prolapse
Urinary Incontinence
Keywords: Pelvic organ prolapse
Surgery
Urinary incontinence
Stress urinary incontinence
Urge-urinary incontinence
Lead sponsor: Hospital Universitari Vall d'Hebron Research Institute
Sponsor class: OTHER
Collaborators: name: Consorci Sanitari de Terrassa
name: Parc Taulí Hospital Universitari
name: Hospital de Viladecans
name: Hospital Universitari de Bellvitge
name: Hospital d'Igualada
name: Hospital de Mataró
name: Fundació Hospital de l'Esperit Sant
name: Germans Trias i Pujol Hospital
name: Hospital Santa Caterina
name: Hospital de Granollers
name: Hospital del Mar
name: Hospital Universitari Joan XXIII de Tarragona.
name: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
First posted: 2022-04-05
Enrollment: 609
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients referred to different Spanish-Catalan hospitals with symptomatic pelvic organ prolapse who are candidates for surgical correction of their POP.

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.


Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* Inability to give consent to the study.

Primary outcomes:
measure: Stress urinary incontinence (SUI).
timeFrame: 1 year after surgery.
measure: Urgency urinary incontinence (UUI).
timeFrame: 1 year after surgery.
Secondary outcomes:
measure: Incontinence severity
timeFrame: 1 year after surgery.
measure: Patients' satisfaction with the procedure.
timeFrame: 1 year after surgery.
Other outcomes:
Locations:
city: Badalona
country: Spain
facility: Hospital Germans Trias i Pujol
state: Barcelona
city: Granollers
country: Spain
facility: Hospital General de Granollers
state: Barcelona
city: Hospitalet de Llobregat
country: Spain
facility: Hospital General de l'Hospitalet
state: Barcelona
city: Igualada
country: Spain
facility: Hospital d'Igualada
state: Barcelona
city: L'Hospitalet De Llobregat
country: Spain
facility: Hospital Universitari de Bellvitge
state: Barcelona
city: Sabadell
country: Spain
facility: Parc Taulí Hospital Universitari
state: Barcelona
city: Santa Coloma De Gramenet
country: Spain
facility: Hospital de l'Esperit Sant
state: Barcelona
city: Terrassa
country: Spain
facility: Consorci Sanitari de Terrassa
state: Barcelona
city: Viladecans
country: Spain
facility: Hospital de Viladecans
state: Barcelona
city: Barcelona
country: Spain
facility: Vall d'Hebron Barcelona Hospital Campus
city: Barcelona
country: Spain
facility: Hospital de Sant Pau
city: Barcelona
country: Spain
facility: Hospital del Mar
city: Girona
country: Spain
facility: Hospital Santa Caterina
city: Tarragona
country: Spain
facility: Hospital Joan XXIII
Study officials:
affiliation: Vall d'Hebron Barcelona Hospital Campus
name: Marina Catalan, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Vall d'Hebron Barcelona Hospital Campus
name: Jordi Sabadell, MD
role: STUDY_DIRECTOR
References: