Retrospective evaluation of a multi center user observation: Long-term results of transvaginal prolapse treatment in the anterior compartment with Calistar S

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00021188

Enrollment

110

Registered

2020-03-27

Start date

2019-09-23

Completion date

Unknown

Last updated

2025-04-07

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

Conditions

N81

Interventions

Group 1: anterior Mesh implantation for treatment of the anterior or anterior and apical prolapse with Calistar S

Eligibility

Sex/Gender

Female

Age

21 Years to No maximum

Inclusion criteria

Inclusion criteria: In the period from March 2016 to December 2018, the correction of an anterior or anterior and apical prolapse with mesh interposition using the Calistar S prolapse correction system should have been carried out in one of the two centers mentioned

Exclusion criteria

Exclusion criteria: - The person is unable to give a declaration of consent - There is no retrospective data available that can be evaluated

Design outcomes

Primary

Measure	Time frame
The primary endpoint is the evaluation of the medium-term to long-term efficiency and safety fo Calistar S for correcting the anterior or anterior and apical prolapse using a transvaginal mesh insertion. For this purpose, three criteria are used: 1: No recurrence, lowest point anterior POP-Q stage = 1 2: No bothersome prolapse symptoms (P-QoL) 3: No need for repeated surgical correction of the anterior or apical prolapse	—

Measure

Time frame

The primary endpoint is the evaluation of the medium-term to long-term efficiency and safety fo Calistar S for correcting the anterior or anterior and apical prolapse using a transvaginal mesh insertion. For this purpose, three criteria are used: 1: No recurrence, lowest point anterior POP-Q stage = 1 2: No bothersome prolapse symptoms (P-QoL) 3: No need for repeated surgical correction of the anterior or apical prolapse

—

Secondary

Measure	Time frame
During a user observation from March 2016 to December 2018, data were collected that are used for the endpoints described below. - Treatment success as percentage of patients in whom three primary targets (1: no recurrence, 2: no bothersome prolapse symptoms, 3: no need for repeated surgical correction of the anterior or apical prolapse) are met at the same time - Frequency of de Novo SUI - Frequency of intraoperative bladder lesion - Quality of Life, German pelvic floor questionnaire and P-QoL - patient satisfaction - Positive anatomical outcome is defined as the proportion of patients who have an anterior POP-Q status of =1, =6 months after the operation. - Recurrence Rate 12 Months, defined as the proportion of patients who had to be treated after =12 months post-intervention due to a mesh related complication	—

Measure

Time frame

During a user observation from March 2016 to December 2018, data were collected that are used for the endpoints described below. - Treatment success as percentage of patients in whom three primary targets (1: no recurrence, 2: no bothersome prolapse symptoms, 3: no need for repeated surgical correction of the anterior or apical prolapse) are met at the same time - Frequency of de Novo SUI - Frequency of intraoperative bladder lesion - Quality of Life, German pelvic floor questionnaire and P-QoL - patient satisfaction - Positive anatomical outcome is defined as the proportion of patients who have an anterior POP-Q status of =1, =6 months after the operation. - Recurrence Rate 12 Months, defined as the proportion of patients who had to be treated after =12 months post-intervention due to a mesh related complication

—

Countries

Germany

Contacts

Public ContactGert Naumann

HELIOS Klinik Erfurt Frauenklinik

gert.naumann@helios-gesundheit.de03617814001

Outcome results

None listed

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