An observational study in Vault Prolapse, Vaginal, sponsored by Universitaire Ziekenhuizen KU Leuven. Enrolling by invitation at 1 site in Belgium. Open to female participants. Per ClinicalTrials.gov, last updated 2025-01-15.
Sponsored by Universitaire Ziekenhuizen KU Leuven · Observational
Among 10 studies in Pelvic Organ Prolapse with a site in Belgium — 3 open to participants now, 3 under way, none of them phase 3. Pelvic Organ Prolapse · Belgium.
Among the 10 studies in Pelvic Organ Prolapse with a site in Belgium, this one is one of 2 that started in 2020, is one of 7 observational ones, and was the 6th registered.
521 studies on the registry are indexed under Pelvic Organ Prolapse; 80 are open to participants now.
Browse Pelvic Organ Prolapse studies →3 of the 10 studies in Pelvic Organ Prolapse with a site in Belgium are open now. Recruiting first, the newest first:
University Hospital, Antwerp · Sites in Belgium
Ages 18+
Universitaire Ziekenhuizen KU Leuven · Sites in Belgium
Ages 18–45 · Women only
A study can be open while its sites in Belgium have not opened yet or have stopped. Only those recruiting at a site in Belgium →
Of the 53 Pelvic Organ Prolapse studies recruiting now, 31 (58%) set no upper age limit and 10 (19%) stop at 75 or younger; 2 take children under 18; 14 take healthy volunteers.
This study: female · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
10 studies; the count open now beside each. This study's row is marked.
First in 2006; this study’s year is marked. 2 started in 2020.
This study's planned enrollment of 250 is above the median of 134 across 171 observational studies indexed under Pelvic Organ Prolapse.
Median enrollment 320 across the 3 interventional studies, 269 across the 7 observational. Of the 5 that completed or were terminated, 1 (20%) have results posted.
This tab as a report to print or save as PDF → With an account.
3 of 10 have an industry lead sponsor. The 6 most frequent:
Universitaire Ziekenhuizen KU Leuven is the lead sponsor of 963 studies on the registry; 267 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Universitaire Ziekenhuizen KU Leuven has 4 studies filed under Pelvic Organ Prolapse — fewer than ten, so there is no comparison to draw.
None of the studies under way reaches primary completion within a year.
Among the 10 studies in Pelvic Organ Prolapse with a site in Belgium, from their registry updates:
Nothing recorded among them since 2026-09-25.
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An institutional audit of the short term complications and long term outcomes of patients undergoing laparoscopic sacrocolpopexy for vault/cervical prolapse.
The aim of this study is to audit the outcomes of laparoscopic sacrocolpopexy procedures done in our unit. The investigators aim to permanently monitor outcomes of this procedure correcting vaginal vault prolapse or cervical descent. Auditing institutional performance with pelvic floor procedures is increasingly being required by (inter)national societies in pelvic floor medicine, so that patients can be counseled on outcomes they can expect at a given institution.
Sacrocolpopexy is offered to patients with symptomatic prolapse (≥stage II) of the vaginal apex (vault or cervix). The procedure involves dissection of the promontory and the vaginal vault, suturing of two meshes to the anterior and posterior aspect of the vagina using minimally three rows of sutures on each side, and one row at the apex. Thereafter the mesh is fixed with staples to the promontory and the peritoneum closed, with staples and a running suture.
The investigators started auditing this procedure 20 years ago because of the conversion to laparoscopy.
High anatomical and subjective cure rates are reported on the medium term (range 12-60 months), though long-term data (60 months or longer) are scarce and most studies focus on anatomical outcomes.4 The investigators recently published medium term outcomes of patients operated up to 2014 1. Now the aim is to extend this audit to patients operated since 2014 and install a process of permanent monitoring our performance with this operation. The investigators also want to use the availability of outcomes in large numbers and/or the long term, to detect potential rare or long term complications, and study the effects of small technical increments such as extending dissections, associate other pelvic floor reconstructive procedures or the change in bio-materials used for this operation. All these may affect outcome.
Primary outcome is a subjective outcome, using a patient-centered approach and report patient reported out-comes. Additional outcomes such as anatomical failure, or complications, both by occurrence and time point, re-interventions, and pelvic floor functional outcomes are secondary outcomes that allows the investigators to benchmark their performance to previous studies and other series. Key in an objective assessment process is that patients are examined by an experienced clinician not involved in the management, which will also be used herein.
Since our last audit (April 30, 2014), we have operated on more than probably another 250 patients, who will be contacted. Based on our previous experience, we expect a 85% response rate.
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.
To be eligible, female subjects must meet the following inclusion criteria:
Exclusion Criteria:
None apart from not meeting the above criteria
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Sacrocolpopexy is offered to patients with symptomatic prolapse (≥stage II) of the vaginal apex (vault or cervix). The procedure involves dissection of the promontory and the vaginal vault, suturing of two meshes to the anterior and posterior aspect of the vagina using minimally three rows of sutures on each side, and one row at the apex. Thereafter the mesh is fixed with staples to the promontory and the peritoneum closed, with staples and a running suture.
Subjective Success Rate
Subjective Success assessed by the Patient Global Impression of Change (PGI-C) tool, which is a 5-point Likert scale, where the patients are asked the following question at the follow up visit: "Compared with how you were doing before your recent pelvic floor operation, would you say that now you are: "much better", "a little better", "about the same", "a little worse" or "much worse".
Time frame: Up to 10 years postoperative
Objective success
Objective Success will be defined as: achievement of a POP-Q score Stage ≤1, without re-intervention for POP or graft related complication at approximately 12 months.
Time frame: Up to 10 years postoperative
Postoperative complications
Occurrence of operative complications: classified as either intra-operative or postoperative (within 3 months of operation), and according to the Dindo classification, as we earlier did.
Time frame: Up to 10 years postoperative
Reintervention rate
Reintervention for prolapse as well as its compartment, at any time point during follow up. The time point of reintervention will be a variable per se.
Time frame: Up to 10 years postoperative
Postoperative graft related complications (GRC)
Postoperative graft related complications (GRC) out of a (non-limitative) list of de novo dyspareunia, worsening of pre-existing dyspareunia, incidence of chronic pain, occurrence of exposure, extrusion or any other complication and any reintervention because of the above. GRC will be categorized according to the IUGA classification
Time frame: Up to 10 years postoperative
Prolapse Quality of Life (P-QoL)
P-QoL: self-reported severity of symptoms in patients with urogenital prolapse and their impact on 9 different quality of life domains with scores for each domain, ranging between 0 and 100. Higher scores indicate a greater impairment of quality of life. This has been validated for the Flemish population
Time frame: Up to 10 years postoperative
Plan to share: No
No publications or documents are linked to this record.
Started Sep 2020 (actual). Primary completion is estimated for Dec 2025, 63 months after the start.
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 63 months is above 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.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
No contact was published for this record. The registry link below has the sponsor’s details.
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