An observational study in Pelvic Organ Prolapse, sponsored by Promedon. Recruiting at 7 sites in Germany. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-11-22.
Sponsored by Promedon · Observational
Among 19 studies in Pelvic Organ Prolapse with a site in Germany — 4 open to participants now, 6 under way, none of them phase 3. Pelvic Organ Prolapse · Germany.
Among the 19 studies in Pelvic Organ Prolapse with a site in Germany, this one is the 6th largest by planned enrollment of the 14 observational ones that give a count, is one of 3 that started in 2022, is one of 14 observational ones, and was the 12th registered.
521 studies on the registry are indexed under Pelvic Organ Prolapse; 80 are open to participants now.
Browse Pelvic Organ Prolapse studies →4 of the 19 studies in Pelvic Organ Prolapse with a site in Germany are open now. Recruiting first, the newest first:
A.M.I. Agency for Medical Innovations GmbH · Sites in Germany, Austria
Ages 18–80 · Women only
A.M.I. Agency for Medical Innovations GmbH · Sites in Germany, Austria
Ages 18+ · Women only
Ethicon, Inc. · Sites in Germany, United States, Austria and 4 more countries
Ages 21+ · Women only
A study can be open while its sites in Germany have not opened yet or have stopped. Only those recruiting at a site in Germany →
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: 18 Years and older · female · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
19 studies; the count open now beside each. This study's row is marked.
First in 2006; this study’s year is marked. 3 started in 2022.
This study's planned enrollment of 140 is close to the median of 134 across 171 observational studies indexed under Pelvic Organ Prolapse.
Median enrollment 85 across the 5 interventional studies, 113 across the 14 observational. Of the 11 that completed or were terminated, 2 (18%) have results posted.
This tab as a report to print or save as PDF → With an account.
13 of 19 have an industry lead sponsor. The 10 most frequent:
Promedon is the lead sponsor of 3 studies on the registry; 1 is open to participants now.
Promedon has 2 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 19 studies in Pelvic Organ Prolapse with a site in Germany, from their registry updates:
This tab as a report to print or save as PDF → With an account.
This prospective, multi center cohort trial aims to evaluate the efficacy and safety of hysteropexy using Splentis via the vaginal route in primary uterine prolapse
Women who undergo hysteropexy with Splentis via the vaginal route for primary uterine prolapse will be evaluated regarding efficacy and safety in a long term follow-up of 60 months. The primary endpoint is composed of anatomical, subjective and re-treatment components, whereas several secondary endpoints focusing on functional outcome including overactive bladder symptoms, urinary incontinence, quality of life and sexual life will be considered. Furthermore, a detailed report about adverse events will be included.
Non-fertile women ≥ 18 years with uterine prolapse
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.
Exclusion 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.
Non-fertile women ≥ 18 years with uterine descent (POP-Q ≥ 2) which are study-independently scheduled for hysteropexy with Splentis
Device: Splentis® POP Tissue Anchoring System
Anterior cervicopexy with bilateral sacrospinous ligament fixation using Splentis
Cure of apical pelvic organ prolapse
Cure of apical pelvic organ prolapse is defined according the current recommendations by Barber et al. and ICS/IUGA recommendations. Therefore, a combined endpoint using anatomical, subjective and necessity retreatment criteria are utilized. Primary endpoint is the number of patients achieving all criteria of the composite endpoint: 1. leading edge of the apical vaginal wall at or above the hymen (C≤ 0) 2. absence of a vaginal bulge symptom 3. no need for retreatment of the apical prolapse by either pessary use or surgical intervention
Time frame: 12 months
Health-related quality of life
Change of Quality of life and prolapse symptoms using the Prolapse-Quality of Life-Questionnaire in comparison between baseline and follow-up. The questionnaire is divided in nine domains which are analyzed separately. The results will be transformed into a scale between 0 - 100 according the questionnaires description. The higher the score, the higher the impact of prolapse symptoms and the lower the quality of life.
Time frame: Baseline, 6 weeks 12, 24, 36, 60 months
Quality of life
Change of quality of life using the EQ-5L-5D in comparison between baseline and follow-up. It consists of a 5-item descriptive system as well as a visual analogue scale ranging from 0 to 100. It is conceptualized to assess deviation from health and hereby provide health related quality of life problems.
Time frame: Baseline, 6 weeks and 12, 24, 36, 60 months
Urinary incontinence
Change of urinary incontinence using the International Consultation on Incontinence Questionnaire- Urinary Incontinence Short From in comparison between baseline and follow-up The ICIQ-UI-SF includes four items with a sum score ranging between 0 and 21 points. The higher the score the higher the impact of symptoms.
Time frame: Baseline, 6 weeks and 12, 24, 36, 60 months
Overactive Bladder
Change of urinary incontinence using the International Consultation on Incontinence Questionnaire- Overactive bladder in comparison between baseline and follow-up The score of the ICIQ-OAB ranges from 0 to 16 points. The higher the sum score the higher the impact of symptoms.
Time frame: Baseline, 6 weeks and 12, 24, 36, 60 months
Sexual life
Change of sexual life using the Pelvic Organ Prolapse Incontinence Sexual Questionnaire- IUGA revised in comparison between baseline and follow-up. The result will be transformed into a scale between 0 - 100. The higher the score, the higher the impact of prolapse symptoms and the higher the impact on sexual life.
Time frame: Baseline, 6 weeks and 12, 24, 36, 60 months
Pain according Visual analogue scale of pain
Change of pain using the visual analogue scale of pain in comparison between baseline and follow-up The Wong-Baker Faces Pain Scale is a visual analogue scale to assess subject pain.The answers will be transformed in a scale from 0 to 10 whereas 0 implicate no pain and 10 worst pain.
Time frame: Baseline, 24-48 hours postoperatively, 6 weeks and 12, 24, 36, 60 months
Patient global impression of improvement
Number of Patients with improvement of prolapse symptoms according the validated question Patient Global Impression of improvement The PGI-I is a seven Likert scale from very much better to no change and very much worse.
Time frame: 6 weeks and 12, 24, 36, 60 months
Cure according composite endpoint
Number of patients completing each component of the composite endpoint
Time frame: 6 weeks and 24, 36, 60 months
Adverse Events
Number and severity of Adverse Events according guideline of AE reporting, Clavien Dindo and Terminology of IUGA/ICS
Time frame: Intraoperatively, 24-48hours postoperatively, 6 weeks postoperatively and 12, 24, 36, 60 months, unscheduled visits
Exposure and extrusion free survival
Estimated exposure and extrusion free survival according Kaplan-Meier.
Time frame: 6 weeks and 12, 24, 36, 60 months
Plan to share: No
No publications or documents are linked to this record.
Started Dec 2022 (actual). Primary completion is estimated for Jul 2026, 43 months after the start.
Of 61 observational studies under Pelvic Organ Prolapse, half reached primary completion within 31 months of starting (the median), counting those still running; a quarter within 16 and three quarters within 63. This study's planned 43 months is above that.
How these figures are worked out, and which studies are left out of them.
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Promedon