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Not yet recruitingNCT07628036Updated Jun 4, 2026

Urinary Continence After Vaginal Surgery for Genital Prolapse in the Spanish Population.

An observational study in Pelvic Organ Prolapse (POP), Pelvic Organ Prolapse Vaginal Surgery and Urinary Incontinence (UI), sponsored by Hospital Universitari Vall d'Hebron Research Institute. Not yet recruiting at 4 sites in Spain. Open to female participants aged 18 Years to 99 Years. Per ClinicalTrials.gov, last updated 2026-06-04.

Sponsored by Hospital Universitari Vall d'Hebron Research Institute · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
1,042
Ages
18 Years to 99 Years
Sex
Female
01

Study 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.

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.

02

Conditions studied

  • 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
03

In context

Pelvic Organ Prolapse

521 studies on the registry are indexed under Pelvic Organ Prolapse; 80 are open to participants now.

This study's planned enrollment of 1,042 is above the median of 134 across 171 observational studies indexed under Pelvic Organ Prolapse.

Browse Pelvic Organ Prolapse studies →

Lead sponsor

Hospital Universitari Vall d'Hebron Research Institute is the lead sponsor of 276 studies on the registry; 64 are open to participants now.

Browse Hospital Universitari Vall d'Hebron Research Institute studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 99 Years
Sexes eligible
Female
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Women referred to different Spanish hospitals for symptomatic pelvic organ prolapse who are candidates for surgical correction of their POP.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Women who will undergo vaginal surgery for pelvic organ prolapse

Exclusion criteria

Exclusion Criteria:

  • inhability to give consent to the study
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
1,042 participants (estimated)
Target follow-up
1 Year
Patient registry
Yes

Groups and cohorts

  • Women with pelvic organ prolapse who are candidates for vaginal surgery for its correction.

    Procedure: Vaginal surgery for pelvic organ prolapse

Interventions

  • ProcedureVaginal surgery for pelvic organ prolapse

    Vaginal surgery of any vaginal compartment for pelvic organ prolapse

06

What researchers measure

Primary outcomes

  1. Stress urinary incontinence (SUI).

    Time frame: 1 year after surgery.

  2. Urgency urinary incontinence (UUI)

    Time frame: 1 year after surgery

Secondary outcomes

  1. Incontinence severity

    Time frame: 1 year after surgery

  2. Patient's satisfaction with the procedure.

    Time frame: 1 year after surgery

07

Study locations

4 sites
  • Vall d'Hebron Barcelona Hospital Campus
    Barcelona, Barcelona, Spain
  • Fundació Hospital de l'Esperit Sant
    Santa Coloma de Gramenet, Barcelona, Spain
    • Sira Capote-López, MD · Contactscapote@fhes.cat · +34 933 86 02 02
    • Sira Capote-López, MD · Principal investigator
  • Hospital Virgen de la Arrixaca
    Murcia, Murcia, Spain
    • Isabel Ñíguez-Sevilla, PhD, MD · Contactisnise@gmail.com · +34968366035
    • Isabel Ñíguez-Sevilla, PhD, MD · Principal investigator
    • Marisa Sánchez-Ferrer, PhD, MD · Sub investigator
  • Complejo Universitario Insular, Hospital materno-infantil
    Las Palmas de Gran Canaria, Tenerife, Spain
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Aug 2026; primary completion for May 2028, 21 months later.

Of 55 non-industry observational studies under Pelvic Organ Prolapse, half reached primary completion within 26 months of starting (the median), counting those still running; a quarter within 15 and three quarters within 51. This study's planned 21 months is below that.

Counting every sponsor, half of 61 studies reached it within 31 months; a quarter within 16 and three quarters within 63.

How these figures are worked out, and which studies are left out of them.

Registered
Jun 1, 2026
First posted
Jun 4, 2026
StartEst.
Aug 1, 2026
Primary completionEst.
May 30, 2028
CompletionEst.
May 30, 2028
Last update
Jun 4, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jun 4, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07628036
Lead sponsor
Hospital Universitari Vall d'Hebron Research Institute
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
First posted
Jun 4, 2026
Start date
Aug 1, 2026 (estimated)
Primary completion
May 30, 2028 (estimated)
Completion
May 30, 2028 (estimated)
Last update
Jun 4, 2026

Study contacts

Jordi Sabadell, MD, PhD
Contact
jordi.sabadell@vallhebron.cat
+34934894010
Sabadell Jordi, MD, PhD.
principal investigator · Hospital Universitari Vall d'Hebron Research Institute

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.

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Discussion

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