Pelvic Organ ProlapseNCT05312047
Continence After Vaginal Prolapse Surgery
An observational study of Pelvic Organ Prolapse and Urinary Incontinence, run by Hospital Universitari Vall d'Hebron Research Institute at 14 sites in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 99 years, women only
- Conditions the study is for
- Pelvic Organ Prolapse, Urinary Incontinence
- What is being tested?
- Pelvic organ prolapse surgery
- Type of treatment
- Surgery or procedure
- How many people
- 609 participants
- Where
- 14 sitesSpain
- Study dates
- 4 Apr 2022to 19 Sep 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Patients referred to different Spanish-Catalan hospitals with symptomatic pelvic organ prolapse who are candidates for surgical correction of their POP.
Who may be able to join
- Women who will undergo vaginal surgery for pelvic organ prolapse.
Who cannot join
- Inability to give consent to the study.
Trial locations and contacts
14 sites in 1 country.
14 sites in 1 country
Spain14 sites
Hospital Germans Trias i Pujol
Badalona, Barcelona
Vall d'Hebron Barcelona Hospital Campus
Barcelona, Barcelona, 08035
Hospital de Sant Pau
Barcelona
Hospital del Mar
Barcelona
Hospital Santa Caterina
Girona
Hospital General de Granollers
Granollers, Barcelona
Hospital d'Igualada
Igualada, Barcelona
Hospital General de l'Hospitalet
L'Hospitalet de Llobregat, Barcelona
Hospital Universitari de Bellvitge
L'Hospitalet de Llobregat, Barcelona
Parc Taulí Hospital Universitari
Sabadell, Barcelona
Hospital de l'Esperit Sant
Santa Coloma de Gramenet, Barcelona
Hospital Joan XXIII
Tarragona
Consorci Sanitari de Terrassa
Terrassa, Barcelona
Hospital de Viladecans
Viladecans, Barcelona
About this study
Official title: 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.
- Conditions
- Pelvic Organ Prolapse, Urinary Incontinence
- Being tested
- Pelvic organ prolapse surgery
- Keywords
- Pelvic organ prolapse, Surgery, Urinary incontinence, Stress urinary incontinence, Urge-urinary incontinence
- Medical subject headings
- Pelvic Organ Prolapse, Urinary Incontinence, Urinary Incontinence, Stress, Urinary Incontinence, Urge
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pelvic organ prolapse surgeryProcedure or surgery
Vaginal surgery of any compartment for pelvic organ prolapse
What is being measured
The primary outcome is the main question the study is designed to answer.
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) .
Measured: 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".
Measured: 1 year after surgery.
Secondary outcomes (2)
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).
Measured: 1 year after surgery.
Patients' satisfaction with the procedure.
Assessed with the Patient Impression of Improvement (PGI-I) form.
Measured: 1 year after surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2022
- Study start4 Apr 2022
- Primary completion19 Sep 2025
- Study completion19 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pelvic Organ ProlapseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 609 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Universitari Vall d'Hebron Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Consorci Sanitari de Terrassa, Parc Taulí Hospital Universitari, Hospital de Viladecans, Hospital Universitari de Bellvitge, Hospital d'Igualada, Hospital de Mataró, Fundació Hospital de l'Esperit Sant, Germans Trias i Pujol Hospital, Hospital Santa Caterina, Hospital de Granollers, Hospital del Mar, Hospital Universitari Joan XXIII de Tarragona., Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
- Responsible party
- Sponsor
- Investigators
- Marina Catalan, MD, Principal investigator, Vall d'Hebron Barcelona Hospital CampusJordi Sabadell, MD, Study director, Vall d'Hebron Barcelona Hospital Campus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05312047
- Sponsor's protocol ID
- PR(AMI)631-2021
- Status last verified
- Dec 2025
- First submitted
- 17 Mar 2022
- Last updated
- 31 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Urinary Continence Status After Vaginal Surgery for Prolapse Correction.
- ClinicalTrials.gov ID
- NCT05312047
- Acronym / sponsor ID
- PR(AMI)631-2021
- Conditions
- Pelvic Organ Prolapse, Urinary Incontinence
- Keywords
- Pelvic organ prolapse, Surgery, Urinary incontinence, Stress urinary incontinence, Urge-urinary incontinence
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 609 participants (actual)
- Lead sponsor
- Hospital Universitari Vall d'Hebron Research InstituteUniversity, hospital or other
- Collaborators
- Consorci Sanitari de Terrassa, Parc Taulí Hospital Universitari, Hospital de Viladecans, Hospital Universitari de Bellvitge, Hospital d'Igualada, Hospital de Mataró, Fundació Hospital de l'Esperit Sant, Germans Trias i Pujol Hospital, Hospital Santa Caterina, Hospital de Granollers, Hospital del Mar, Hospital Universitari Joan XXIII de Tarragona., Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
- Study start
- 4 Apr 2022 (actual)
- Primary completion
- 19 Sep 2025 (actual)
- Study completion
- 19 Sep 2025 (actual)
- First posted
- 5 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 99 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients referred to different Spanish-Catalan hospitals with symptomatic pelvic organ prolapse who are candidates for surgical correction of their POP.
Key inclusion criteria (1 listed)
- Women who will undergo vaginal surgery for pelvic organ prolapse.
Key exclusion criteria (1 listed)
- Inability to give consent to the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pelvic organ prolapse surgeryVaginal surgery of any compartment for pelvic organ prolapse | Procedure or surgery | – |
Primary outcome
Stress urinary incontinence (SUI).
Time frame: 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).
Time frame: 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".
2 secondary outcomes
Incontinence severity
Time frame: 1 year after surgery.
Patients' satisfaction with the procedure.
Time frame: 1 year after surgery.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Dec 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marina Catalan, MD principal investigator
Vall d'Hebron Barcelona Hospital Campus
Jordi Sabadell, MD study director
Vall d'Hebron Barcelona Hospital Campus
14 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pelvic Organ Prolapse and Urinary Incontinence, run by Hospital Universitari Vall d'Hebron Research Institute at 14 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Stress urinary incontinence (SUI). (time frame: 1 year after surgery.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Dec 2025.