Retrospective evaluation of short term outcomes after bilateral sacrospinous fixation with Splentis

Retrospective evaluation of short term outcomes after bilateral sacrospinous fixation with Splentis - RESTOS

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00032572

Enrollment

350

Registered

2024-01-08

Start date

2024-01-09

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

N81.2

Interventions

Group 1: Splentis surgical procedure and regular clinical follow-up with history, clinical examination and patient questionnaire (retrospective analysis)

Eligibility

Sex/Gender

Female

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: Completed surgical treatment with Splentis device

Exclusion criteria

Exclusion criteria: internal documentation not complete less than 1 ambulatory follow-up visit

Design outcomes

Primary

Measure	Time frame
Number of cases showing successful repair of the apical pelvic organ prolapse at last follow-up. Successful repair is defined according to the following combined endpoint criteria : - No apical descensus beyond the hymenal hemline - No need for repeated surgical treatment or use of a pessary due to apical prolapse (health records)	—

Secondary

Measure	Time frame
Complications Functional result (questionnaire)	—

Countries

Germany

Contacts

Public ContactGert Naumann

HELIOS Klinik Erfurt

gert.naumann@helios-gesundheit.de+49 0361 781 4001

Outcome results

None listed

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