Pessary insertion directly post partum: does it reduce pelvic organ prolapse symptoms one year postpartum compared with standard care? A randomised controlled trial

Pessary insertion directly post partum: does it reduce pelvic organ prolapse symptoms one year postpartum compared with standard care? A randomised controlled trial - PP-Pess

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

DRKS

Registry ID

DRKS00007897

Enrollment

302

Registered

2016-12-02

Start date

2016-12-15

Completion date

Unknown

Last updated

2025-10-06

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

Conditions

Cystocele Stress incontinence

Interventions

Group 1: Pessary insertion day 1-3 postpartum (modifiable Hodge or ring pessary), for 4-6 weeks Group 2: Standard care (no Intervention) Group 3: Patient-preference groups: pessary or standard care

Eligibility

Sex/Gender

Female

Age

18 Years to 45 Years

Inclusion criteria

Inclusion criteria: Primipara, vaginal birth, physical and mental health, able to attend follow up examination

Exclusion criteria

Exclusion criteria: Death of Fetus, severe birth trauma, postpartum hysterectomy, severe pain, unable to attend follow up, neurological diseases, previous pelvic floor operation

Design outcomes

Primary

Measure	Time frame
Pelvic floor function (Prolapse symptoms) 12 months postpartum (assessment with validated Pelvic Floor Questionnaire)	—

Secondary

Measure	Time frame
Prolapse (POPQ) and pelvic floor symptoms 6 weeks and one year postpartum (German version of Australian Pelvic Floor Questionnaire) Interim analysis scheduled at 6 weeks to assess pelvic floor function	—

Countries

Germany

Contacts

Public ContactKaven Baessler

Charité Universitätsmedizin

kaven.baessler@charite.de030450564803

Outcome results

None listed

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