NCT05312047

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
609

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2022

Typical duration for all trials

Geographic Reach
1 country

14 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 17, 2022

Completed
18 days until next milestone

Study Start

First participant enrolled

April 4, 2022

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 5, 2022

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 19, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 19, 2025

Completed
Last Updated

December 31, 2025

Status Verified

December 1, 2025

Enrollment Period

3.5 years

First QC Date

March 17, 2022

Last Update Submit

December 24, 2025

Conditions

Pelvic Organ ProlapseUrinary Incontinence

Keywords

Pelvic organ prolapseSurgeryUrinary incontinenceStress urinary incontinenceUrge-urinary incontinence

Outcome Measures

Primary Outcomes (2)

  • 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.

  • 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 Outcomes (2)

  • Incontinence severity

    1 year after surgery.

  • Patients' satisfaction with the procedure.

    1 year after surgery.

Interventions

Pelvic organ prolapse surgeryPROCEDURE

Vaginal surgery of any compartment for pelvic organ prolapse

Eligibility Criteria

Age18 Years - 99 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

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

You may not qualify if:

  • Inability to give consent to the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (14)

Hospital Germans Trias i Pujol

Badalona, Barcelona, Spain

Location

Vall d'Hebron Barcelona Hospital Campus

Barcelona, Barcelona, 08035, Spain

Location

Hospital General de Granollers

Granollers, Barcelona, Spain

Location

Hospital d'Igualada

Igualada, Barcelona, Spain

Location

Hospital General de l'Hospitalet

L'Hospitalet de Llobregat, Barcelona, Spain

Location

Hospital Universitari de Bellvitge

L'Hospitalet de Llobregat, Barcelona, Spain

Location

Parc Taulí Hospital Universitari

Sabadell, Barcelona, Spain

Location

Hospital de l'Esperit Sant

Santa Coloma de Gramenet, Barcelona, Spain

Location

Consorci Sanitari de Terrassa

Terrassa, Barcelona, Spain

Location

Hospital de Viladecans

Viladecans, Barcelona, Spain

Location

Hospital de Sant Pau

Barcelona, Spain

Location

Hospital del Mar

Barcelona, Spain

Location

Hospital Santa Caterina

Girona, Spain

Location

Hospital Joan XXIII

Tarragona, Spain

Location

MeSH Terms

Conditions

Pelvic Organ ProlapseUrinary IncontinenceUrinary Incontinence, StressUrinary Incontinence, Urge

Condition Hierarchy (Ancestors)

ProlapsePathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsUrination DisordersUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesLower Urinary Tract SymptomsUrological ManifestationsSigns and Symptoms

Study Officials

  • Marina Catalan, MD

    Vall d'Hebron Barcelona Hospital Campus

    PRINCIPAL INVESTIGATOR

  • Jordi Sabadell, MD

    Vall d'Hebron Barcelona Hospital Campus

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 17, 2022

First Posted

April 5, 2022

Study Start

April 4, 2022

Primary Completion

September 19, 2025

Study Completion

September 19, 2025

Last Updated

December 31, 2025

Record last verified: 2025-12

Locations

ES(14)