Continence After Vaginal Prolapse Surgery

Urinary Continence Status After Vaginal Surgery for Prolapse Correction.

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.

Study Overview

• Status: Recruiting
• Conditions: Urinary Incontinence; Pelvic Organ Prolapse
• Intervention / Treatment: Procedure: Pelvic organ prolapse surgery

• Study Type: Observational
• Enrollment (Estimated): 600

Contacts and Locations

• Study Contact: Name: Jordi Sabadell, MD; Phone Number: +34934894010; Email: jordi.sabadell@vallhebron.cat
• Study Contact Backup: Name: Marina Catalan, MD; Email: marina.catalan@vallhebron.cat

Study Locations

• Spain
  • Barcelona, Spain
    • Recruiting
    • Hospital de Sant Pau
    • Contact: Irene Mora
    • Principal Investigator: Irene Mora
  • Barcelona, Spain
    • Recruiting
    • Hospital del Mar
    • Contact: Iris Aran
    • Principal Investigator: Iris Aran
    • Sub-Investigator: Elisabet del Amo
  • Barcelona, Spain, 08035
    • Recruiting
    • Vall d'Hebron Barcelona Hospital Campus
    • Contact: Jordi Sabadell
    • Principal Investigator: Marina Catalan
  • Girona, Spain
    • Recruiting
    • Hospital Santa Caterina
    • Contact: Mª del Àngel Ribary
    • Principal Investigator: Mª del Àngel Ribary
    • Sub-Investigator: Alicia Carrera
  • Tarragona, Spain
    • Recruiting
    • Hospital Joan XXIII
    • Contact: Mª Jose Miranda
    • Principal Investigator: Mª Jose Miranda
    • Sub-Investigator: Miriam de la Flor
  • Barcelona
    • Badalona, Barcelona, Spain
      • Recruiting
      • Hospital Germans Trias i Pujol
      • Contact: Rosana Díaz-Souto
      • Principal Investigator: Rosana Díaz-Souto
    • Granollers, Barcelona, Spain
      • Recruiting
      • Hospital General de Granollers
      • Contact: Ana Pereda
      • Principal Investigator: Ana Pereda
    • Hospitalet de Llobregat, Barcelona, Spain
      • Recruiting
      • Hospital General de l'Hospitalet
      • Contact: Jordi Genovés
      • Principal Investigator: Jordi Genovés
      • Sub-Investigator: Cristina Berdié
    • Igualada, Barcelona, Spain
      • Recruiting
      • Hospital d'Igualada
      • Contact: Alda Amela
      • Principal Investigator: Alda Amela
      • Sub-Investigator: Alba Lopez
    • L'Hospitalet De Llobregat, Barcelona, Spain
      • Recruiting
      • Hospital Universitari de Bellvitge
      • Contact: Miriam Campos
      • Principal Investigator: Miriam Campos
    • Sabadell, Barcelona, Spain
      • Recruiting
      • Parc Tauli Hospital Universitari
      • Contact: Montserrat Mestre
      • Principal Investigator: Montserrat Mestre
    • Santa Coloma De Gramenet, Barcelona, Spain
      • Recruiting
      • Hospital de l'Esperit Sant
      • Contact: Sira Capote
      • Sub-Investigator: Judit Lleberia
      • Principal Investigator: Sira Capote
    • Terrassa, Barcelona, Spain
      • Recruiting
      • Consorci Sanitari de Terrassa
      • Contact: Albert Font
      • Principal Investigator: Albert Font
      • Sub-Investigator: Marino Romero
    • Viladecans, Barcelona, Spain
      • Recruiting
      • Hospital de Viladecans
      • Contact: Cristina Molinet
      • Principal Investigator: Cristina Molinet
      • Sub-Investigator: Carmen Gonzalez

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-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.

Description

Inclusion Criteria:

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

Exclusion Criteria:

• Inability to give consent to the study.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incontinence severity	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).	1 year after surgery.
Patients' satisfaction with the procedure.	Assessed with the Patient Impression of Improvement (PGI-I) form.	1 year after surgery.

Collaborators and Investigators

• Sponsor: Hospital Universitari Vall d'Hebron Research Institute
• Collaborators: Germans Trias i Pujol Hospital; Hospital del Mar; Hospital Universitari de Bellvitge; Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau; Hospital Universitari Joan XXIII de Tarragona.; Hospital de Granollers; Hospital de Mataró; Consorci Sanitari de Terrassa; Hospital Parc Taulí, Sabadell; Hospital de Viladecans; Hospital Santa Caterina; Hospital d'Igualada; Fundació Hospital de l'Esperit Sant
• Investigators: Principal Investigator: Marina Catalan, MD, Vall d'Hebron Barcelona Hospital Campus; Study Director: Jordi Sabadell, MD, Vall d'Hebron Barcelona Hospital Campus

Study record dates

Study Major Dates

• Study Start (Actual): April 4, 2022
• Primary Completion (Estimated): May 1, 2024
• Study Completion (Estimated): May 1, 2024

Study Registration Dates

• First Submitted: March 17, 2022
• First Submitted That Met QC Criteria: March 28, 2022
• First Posted (Actual): April 5, 2022

Study Record Updates

• Last Update Posted (Actual): June 9, 2023
• Last Update Submitted That Met QC Criteria: June 8, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: Surgery; Urinary incontinence; Stress urinary incontinence; Pelvic organ prolapse; Urge-urinary incontinence
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Urologic Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Urination Disorders; Pathological Conditions, Anatomical; Elimination Disorders; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Urinary Incontinence; Prolapse; Pelvic Organ Prolapse; Enuresis
• Other Study ID Numbers: PR(AMI)631-2021

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