Prospective observational study to evaluate the efficacy and safety of laparoscopic bilateral uterosacropexy with DynaMesh®-CESA and VASA mesh implants in women with pelvic organ prolapse

Prospective observational study to evaluate the efficacy and safety of laparoscopic bilateral uterosacropexy with DynaMesh®-CESA and VASA mesh implants in women with pelvic organ prolapse - Pro-USA-AWB

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00032443

Enrollment

163

Registered

2023-08-08

Start date

2023-08-16

Completion date

Unknown

Last updated

2026-03-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

N81.2

Interventions

Group 1: Patients with pelvic organ prolapse symptoms (at least apical descensus uteri, measured as POPQ > 1) with or without associated urinary incontinence who will undergo uterosacropexy using a Dy

Eligibility

Sex/Gender

Female

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: • Impaired by pelvic organ prolaps symptoms >4 (according to the Numerical Rating Scale (NRS) score from 0-10, where 0 = not affected to 10 = severely affected) • Signed declaration of consent including authorization for data processing • Women of childbearing potential with adequate contraceptive protection. Safe contraceptive measures are considered (Pearl Index < 1%): • Oral hormonal contraception (“the pill”), dermal hormonal contraception or contraceptive patch • Vaginal hormonal contraception • Long-acting injectable contraceptives • Progesterone-releasing implant • Female sterilization • Hormonal intrauterine device

Exclusion criteria

Exclusion criteria: • Serious, life-threatening and/or active malignancy • Congenital uterine anomalies • Conspicuous PAP smears or evidence of CIN II/III or unexplained postmenopausal bleeding • Surgical pre-treatment for descensus uteri • Existing or planned pregnancy: In patients of childbearing age, pregnancy must be ruled out by means of a pregnancy test or other suitable methods.

Design outcomes

Primary

Measure	Time frame
Frequency of anatomical recurrences (repeated apical descensus, measured as POPQ > 1) with/without reoperation.	—

Secondary

Measure	Time frame
The secondary endpoints are used to assess the safety of the product. Measured by the incidence of potential (mesh-related) postoperative complications. As part of the integrated, contrast medium-free MRI study, the position, fixation points (posterior wall of the cervix and os sacrum) and the course of the ligament, including anatomical changes.	—

Countries

Germany

Contacts

Public ContactSebastian Ludwig

Universitätsklinikum Köln AöR

sebastian.ludwig@uk-koeln.deTel: 0221 / 478 87550

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Apr 4, 2026