Pelvic Organ Prolapse (POP)NCT07628036
Urinary Continence After Vaginal Surgery for Genital Prolapse in the Spanish Population.
An observational study of Pelvic Organ Prolapse (POP) and Pelvic Organ Prolapse Vaginal Surgery, run by Hospital Universitari Vall d'Hebron Research Institute at 4 sites in Spain.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 99 years, women only
- Conditions the study is for
- Pelvic Organ Prolapse (POP), Pelvic Organ Prolapse Vaginal Surgery, Urinary Incontinence (UI)
- What is being tested?
- Vaginal surgery for pelvic organ prolapse
- Type of treatment
- Surgery or procedure
- How many people
- 1,042 participants
- Where
- 4 sitesSpain
- Study dates
- 1 Aug 2026to 30 May 2028
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: Women referred to different Spanish hospitals for 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
- inhability to give consent to the study
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Spain4 sites
Vall d'Hebron Barcelona Hospital Campus
Barcelona, Barcelona
Jordi Sabadell, +34934894010, jordi.sabadell@vallhebron.cat
Complejo Universitario Insular, Hospital materno-infantil
Las Palmas de Gran Canaria, Tenerife
Sonia Carballo-Rastrilla, MD, +34 928 44 45 00, scarras@gobiernodecanarias.org
Sonia Carballo-Rastrilla, MD
Hospital Virgen de la Arrixaca
Murcia, Murcia
Isabel Ñíguez-Sevilla, PhD, MD, +34968366035, isnise@gmail.com
Isabel Ñíguez-Sevilla, PhD, MD
Fundació Hospital de l'Esperit Sant
Santa Coloma de Gramenet, Barcelona
Sira Capote-López, MD, +34 933 86 02 02, scapote@fhes.cat
Sira Capote-López, MD
About this study
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.
- Conditions
- Pelvic Organ Prolapse (POP), Pelvic Organ Prolapse Vaginal Surgery, Urinary Incontinence (UI)
- Being tested
- Vaginal surgery for pelvic organ prolapse
- Keywords
- Pelvic organ prolapse, Vaginal 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.
Vaginal surgery for pelvic organ prolapseProcedure or surgery
Vaginal surgery of any vaginal compartment for pelvic organ prolapse
| Study group | Role | What they receive |
|---|---|---|
| Women with pelvic organ prolapse who are candidates for vaginal surgery for its correction. | Not described Receives: Procedure: Vaginal surgery 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).
Measured: 1 year after surgery.
Urgency urinary incontinence (UUI)
Measured: 1 year after surgery
Secondary outcomes (2)
Incontinence severity
Measured: 1 year after surgery
Patient's satisfaction with the procedure.
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 posted4 Jun 2026
- Study start1 Aug 2026 (estimated)
- Primary completion30 May 2028 (estimated)
- Study completion30 May 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pelvic Organ Prolapse (POP)Studies of the same condition, open and under way.
- More trials run by Hospital Universitari Vall d'Hebron Research InstituteThe sponsor's other registered studies.
- 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
- 1,042 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital Virgen de la Arrixaca, Murcia, Hospital Materno-Infantil de Canarias. Las Palmas de Gran Canaria. Spain, Hospital de l'Esperit Sant, Consorci Sanitari de Terrassa
- Responsible party
- Sponsor
- Investigators
- Sabadell Jordi, MD, PhD., Principal investigator, Hospital Universitari Vall d'Hebron Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07628036
- Sponsor's protocol ID
- PR(AMI)373-2024
- Status last verified
- Jun 2026
- First submitted
- 1 Jun 2026
- Last updated
- 4 Jun 2026
- 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 4 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Urinary Continence After Vaginal Surgery for Genital Prolapse in the Spanish Population.
- ClinicalTrials.gov ID
- NCT07628036
- Acronym / sponsor ID
- PR(AMI)373-2024
- Conditions
- Pelvic Organ Prolapse (POP), Pelvic Organ Prolapse Vaginal Surgery, Urinary Incontinence (UI)
- Keywords
- Pelvic organ prolapse, Vaginal surgery, Urinary incontinence, Stress urinary incontinence, Urge-urinary incontinence
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 1,042 participants (estimated)
- Lead sponsor
- Hospital Universitari Vall d'Hebron Research InstituteUniversity, hospital or other
- Collaborators
- University Hospital Virgen de la Arrixaca, Murcia, Hospital Materno-Infantil de Canarias. Las Palmas de Gran Canaria. Spain, Hospital de l'Esperit Sant, Consorci Sanitari de Terrassa
- Study start
- 1 Aug 2026 (estimated)
- Primary completion
- 30 May 2028 (estimated)
- Study completion
- 30 May 2028 (estimated)
- First posted
- 4 Jun 2026 (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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Women with pelvic organ prolapse who are candidates for vaginal surgery for its correction. | – | Procedure: Vaginal surgery for pelvic organ prolapse |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Women referred to different Spanish hospitals for 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)
- inhability 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 |
|---|---|---|
| Vaginal surgery for pelvic organ prolapseVaginal surgery of any vaginal compartment for pelvic organ prolapse | Procedure or surgery | Women with pelvic organ prolapse who are candidates for vaginal surgery for its correction. |
Primary outcome
Stress urinary incontinence (SUI).
Time frame: 1 year after surgery.
Urgency urinary incontinence (UUI)
Time frame: 1 year after surgery
2 secondary outcomes
Incontinence severity
Time frame: 1 year after surgery
Patient's satisfaction with the procedure.
Time frame: 1 year after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Pelvic Organ Prolapse (POP)
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Perineal Protection Device for Reducing Perineal Trauma During Vaginal Delivery in First-time Mothers: a Multicenter Randomized Controlled Trial
Pelvic Floor Dysfunction, Perineal Laceration
Not yet recruitingPhase 4
Suzetrigine Following Urogynecologic Surgery: Investigation of Postoperative Pain Management
Pelvic Organ Prolapse (POP), Postoperative Pain
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A Novel Laparoscopic Apical Promontofixation Technique With Simultaneous Perineal Reconstruction for Patients With Symptomatic Pelvic Organ Prolapse
Pelvic Organ Prolapse (POP), Urinary Incontinence , Stress
Not yet recruitingPhase 4
Suzetrigine for Opioid-Sparing Postoperative Analgesia Following Transvaginal Pelvic Reconstructive Surgery
Pelvic Organ Prolapse (POP), Stress Urinary Incontinence (SUI)
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.
Sabadell Jordi, MD, PhD. principal investigator
Hospital Universitari Vall d'Hebron Research Institute
4 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 (POP) and Pelvic Organ Prolapse Vaginal Surgery, run by Hospital Universitari Vall d'Hebron Research Institute at 4 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: opening soon, as of the sponsor's last update on 4 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jordi Sabadell, MD, PhD (+34934894010, jordi.sabadell@vallhebron.cat), or a site near the patient. 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 4 Jun 2026.