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Not yet recruiting NCT07628036

Urinary Continence After Vaginal Surgery for Genital Prolapse in the Spanish Population.

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

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Vaginal surgery for pelvic organ prolapse.
Who it may be relevant to
Registry conditions: Pelvic Organ Prolapse (POP), Pelvic Organ Prolapse Vaginal Surgery, Urinary Incontinence (UI). Basic parameters: 18 years — 99 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Spain
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Interventions

  • Procedure Vaginal surgery for pelvic organ prolapse
    Vaginal surgery of any vaginal compartment for pelvic organ prolapse

Primary outcome measures

  • Stress urinary incontinence (SUI). [Time frame: 1 year after surgery.]
  • Urgency urinary incontinence (UUI) [Time frame: 1 year after surgery]
Secondary outcome measures (2)
  • Incontinence severity [Time frame: 1 year after surgery]
  • Patient's satisfaction with the procedure. [Time frame: 1 year after surgery]

Eligibility criteria

Inclusion criteria

  • Women who will undergo vaginal surgery for pelvic organ prolapse

Exclusion criteria

  • inhability to give consent to the study

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Spain · 4 centers
  • Vall d'Hebron Barcelona Hospital Campus — Barcelona
  • Fundació Hospital de l'Esperit Sant — Santa Coloma de Gramenet
  • Hospital Virgen de la Arrixaca — Murcia
  • Complejo Universitario Insular, Hospital materno-infantil — Las Palmas de Gran Canaria

Identifiers

NCT: NCT07628036 · PR(AMI)373-2024

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗