Continence After Vaginal Prolapse Surgery

Sponsor
Hospital Universitari Vall d'Hebron Research Institute (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05312047
Collaborator
(none)
600
Enrollment
1
Location
24
Anticipated Duration (Months)
25
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or DiseaseIntervention/TreatmentPhase
  • Procedure: Pelvic organ prolapse surgery

Study Design

Study Type:
Observational
Anticipated Enrollment :
600 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Urinary Continence Status After Vaginal Surgery for Prolapse Correction.
Anticipated Study Start Date :
May 1, 2022
Anticipated Primary Completion Date :
May 1, 2024
Anticipated Study Completion Date :
May 1, 2024

Outcome Measures

Primary Outcome Measures

  1. Stress urinary incontinence (SUI). [1 year after surgery.]

    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) .

  2. Urgency urinary incontinence (UUI). [1 year after surgery.]

    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".

Secondary Outcome Measures

  1. Incontinence severity [1 year after surgery.]

    Both SUI and UII severity will be assessed using the spanish versions of the Sandvik's severity index and the International Consultation on Incontinence Questionnaire Short Form (ICIQ-SF).

  2. Patients' satisfaction with the procedure. [1 year after surgery.]

    Assessed with the Patient Impression of Improvement (PGI-I) form.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 99 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Women who will undergo vaginal surgery for pelvic organ prolapse.
Exclusion Criteria:
  • Inability to give consent to the study.

Contacts and Locations

Locations

SiteCityStateCountryPostal Code
1Vall d'Hebron Barcelona Hospital CampusBarcelonaSpain08035

Sponsors and Collaborators

  • Hospital Universitari Vall d'Hebron Research Institute

Investigators

  • Principal Investigator: Marina Catalan, MD, Vall d'Hebron Barcelona Hospital Campus
  • Study Director: Jordi Sabadell, MD, Vall d'Hebron Barcelona Hospital Campus

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Hospital Universitari Vall d'Hebron Research Institute
ClinicalTrials.gov Identifier:
NCT05312047
Other Study ID Numbers:
  • PR(AMI)631-2021
First Posted:
Apr 5, 2022
Last Update Posted:
Apr 5, 2022
Last Verified:
Mar 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Hospital Universitari Vall d'Hebron Research Institute
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 5, 2022