NCT07628036

Brief Summary

Surgical correction of pelvic organ prolapse (POP) may be associated with the development of postoperative stress urinary incontinence (SUI). This clearly affects women's satisfaction and their quality of life, and may require subsequent medical and/or surgical treatments. On the other hand, pre-existing SUI could resolve after corrective prolapse surgery. Similarly, urge urinary incontinence (UUI) could appear or improve after vaginal POP surgery. Therefore, it is of paramount importance to know the prevalence of urinary incontinence after POP vaginal surgery and incontinence resolution in our population. Identifying the risk factors for the development of urinary incontinence may allow to provide individualized treatment.

Trial Health

63
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Trial Health Score

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

Enrollment
1,042

participants targeted

Target at P75+ for all trials

Timeline
22mo left

Started Aug 2026

Geographic Reach
1 country

4 active sites

Status
not yet recruiting

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

June 1, 2026

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 4, 2026

Completed
2 months until next milestone

Study Start

First participant enrolled

August 1, 2026

Expected
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2028

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2028

Last Updated

June 4, 2026

Status Verified

June 1, 2026

Enrollment Period

1.8 years

First QC Date

June 1, 2026

Last Update Submit

June 1, 2026

Conditions

Pelvic Organ Prolapse (POP)Urinary Incontinence (UI)Pelvic Organ Prolapse Vaginal Surgery

Keywords

Pelvic organ prolapseVaginal surgeryUrinary incontinenceStress urinary incontinenceUrge-urinary incontinence

Outcome Measures

Primary Outcomes (2)

  • Stress urinary incontinence (SUI).

    1 year after surgery.

  • Urgency urinary incontinence (UUI)

    1 year after surgery

Secondary Outcomes (2)

  • Incontinence severity

    1 year after surgery

  • Patient's satisfaction with the procedure.

    1 year after surgery

Study Arms (1)

Women with pelvic organ prolapse who are candidates for vaginal surgery for its correction.

Procedure: Vaginal surgery for pelvic organ prolapse

Interventions

Vaginal surgery for pelvic organ prolapsePROCEDURE

Vaginal surgery of any vaginal compartment for pelvic organ prolapse

Women with pelvic organ prolapse who are candidates for vaginal surgery for its correction.

Eligibility Criteria

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

Women referred to different Spanish hospitals for 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:

  • inhability to give consent to the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Vall d'Hebron Barcelona Hospital Campus

Barcelona, Barcelona, Spain

Location

Fundació Hospital de l'Esperit Sant

Santa Coloma de Gramenet, Barcelona, Spain

Location

Hospital Virgen de la Arrixaca

Murcia, Murcia, Spain

Location

Complejo Universitario Insular, Hospital materno-infantil

Las Palmas de Gran Canaria, Tenerife, 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

  • Sabadell Jordi, MD, PhD.

    Hospital Universitari Vall d'Hebron Research Institute

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jordi Sabadell, MD, PhD

CONTACT

+34934894010jordi.sabadell@vallhebron.cat

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
1 Year
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 1, 2026

First Posted

June 4, 2026

Study Start (Estimated)

August 1, 2026

Primary Completion (Estimated)

May 30, 2028

Study Completion (Estimated)

May 30, 2028

Last Updated

June 4, 2026

Record last verified: 2026-06

Locations

ES(4)