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

June 1, 2026 updated by: Hospital Universitari Vall d'Hebron Research Institute

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

1042

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Spain
    • Barcelona
      • Barcelona, Barcelona, Spain
      • Santa Coloma de Gramenet, Barcelona, Spain
        • Fundacio Hospital de l'Esperit Sant
        • Contact:
        • Principal Investigator:
          • Sira Capote-López, MD
    • Murcia
      • Murcia, Murcia, Spain
        • Hospital Virgen de la Arrixaca
        • Contact:
          • Isabel Ñíguez-Sevilla, PhD, MD
          • Phone Number: +34968366035
          • Email: isnise@gmail.com
        • Principal Investigator:
          • Isabel Ñíguez-Sevilla, PhD, MD
        • Sub-Investigator:
          • Marisa Sánchez-Ferrer, PhD, MD
    • Tenerife
      • Las Palmas de Gran Canaria, Tenerife, Spain
        • Complejo Universitario Insular, Hospital materno-infantil
        • Contact:
        • Principal Investigator:
          • Sonia Carballo-Rastrilla, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Women referred to different Spanish hospitals for symptomatic pelvic organ prolapse who are candidates for surgical correction of their POP.

Description

Inclusion Criteria:

  • Women who will undergo vaginal surgery for pelvic organ prolapse

Exclusion Criteria:

  • inhability to give consent to the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Women with pelvic organ prolapse who are candidates for vaginal surgery for its correction.
Procedure: Vaginal surgery for pelvic organ prolapse
Vaginal surgery of any vaginal compartment for pelvic organ prolapse

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Stress urinary incontinence (SUI).
Time Frame: 1 year after surgery.
1 year after surgery.
Urgency urinary incontinence (UUI)
Time Frame: 1 year after surgery
1 year after surgery

Secondary Outcome Measures

Outcome Measure
Time Frame
Incontinence severity
Time Frame: 1 year after surgery
1 year after surgery
Patient's satisfaction with the procedure.
Time Frame: 1 year after surgery
1 year after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Universitari Vall d'Hebron Research Institute

Collaborators

Consorci Sanitari de Terrassa
Hospital de l'Esperit Sant
University Hospital Virgen de la Arrixaca, Murcia
Hospital Materno-Infantil de Canarias. Las Palmas de Gran Canaria. Spain

Investigators

  • Principal Investigator: Sabadell Jordi, MD, PhD., Hospital Universitari Vall d'Hebron Research Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

August 1, 2026

Primary Completion (Estimated)

May 30, 2028

Study Completion (Estimated)

May 30, 2028

Study Registration Dates

First Submitted

June 1, 2026

First Submitted That Met QC Criteria

June 1, 2026

First Posted (Actual)

June 4, 2026

Study Record Updates

Last Update Posted (Actual)

June 4, 2026

Last Update Submitted That Met QC Criteria

June 1, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PR(AMI)373-2024

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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