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
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.
- 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
- Lead sponsor
- Hospital Universitari Vall d'Hebron Research Institute
- 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