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Continence After Vaginal Prolapse Surgery

Urinary Continence Status After Vaginal Surgery for Prolapse Correction.

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05312047
Enrollment
609
Registered
2022-04-05
Start date
2022-04-04
Completion date
2025-09-19
Last updated
2025-12-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pelvic Organ Prolapse, Urinary Incontinence

Keywords

Pelvic organ prolapse, Surgery, Urinary incontinence, Stress urinary incontinence, Urge-urinary incontinence

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.

Interventions

PROCEDUREPelvic organ prolapse surgery

Vaginal surgery of any compartment for pelvic organ prolapse

Sponsors

Consorci Sanitari de Terrassa
CollaboratorOTHER
Parc Taulí Hospital Universitari
CollaboratorOTHER
Hospital de Viladecans
CollaboratorOTHER
Hospital Universitari de Bellvitge
CollaboratorOTHER
Hospital d'Igualada
CollaboratorOTHER
Hospital de Mataró
CollaboratorOTHER
Fundació Hospital de l'Esperit Sant
CollaboratorUNKNOWN
Germans Trias i Pujol Hospital
CollaboratorOTHER
Hospital Santa Caterina
CollaboratorUNKNOWN
Hospital de Granollers
CollaboratorOTHER
Hospital del Mar
CollaboratorOTHER
Hospital Universitari Joan XXIII de Tarragona.
CollaboratorOTHER
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
CollaboratorOTHER
Hospital Universitari Vall d'Hebron Research Institute
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 99 Years
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

* Inability to give consent to the study.

Design outcomes

Primary

MeasureTime frameDescription
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) .
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

MeasureTime frameDescription
Incontinence severity1 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).
Patients' satisfaction with the procedure.1 year after surgery.Assessed with the Patient Impression of Improvement (PGI-I) form.

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026