Compliance to pessary therapy with preventive indication

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

DRKS

Registry ID

DRKS00024733

Enrollment

600

Registered

2021-04-19

Start date

2021-04-26

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

N39.3 N81.9

Interventions

Group 1: Study participants with urinary incontinence or symptoms of pelvic organ prolapse with use of the pessary. Six weeks postpartum, these study participants will be asked to take an online surv

Eligibility

Sex/Gender

Female

Age

18 Years to 50 Years

Inclusion criteria

Inclusion criteria: Currently after delivery in the last 6 weeks and completion of the puerperium

Exclusion criteria

Exclusion criteria: • Women who do not want to participate in the study • Women who cannot read • Women who cannot understand the information sheet • Women who do not understand the German language • Women with intact / inflamed vaginal mucosa • Women with silicone intolerance • Women who cannot insert or remove the pessary on their own

Design outcomes

Primary

Measure	Time frame
Symptom reduction one year postpartum in 10% of women with urinary incontinence or symptoms of pelvic organ prolapse using a pessary compared to women with symptoms without using a pessary. Six weeks postpartum, all study participants will be asked to take an online survey on pelvic floor symptoms. For this purpose, the validated pelvic floor questionnaire for postpartum women will be applied (Metz, et al 2017). The study participants who decided to use the pessary will be informed when to start. Two weeks after they started using the pessary, these study participants will be asked to take an online survey on the use and comfort of the pessary (Beilecke K et al 2017, Baessler K et al 2011). Three months, six months and one year postpartum another survey on the use of the pessary will take place. One year postpartum, all participants will be asked to answer again and for the very last time the online survey on pelvic floor symptoms.	—

Measure

Time frame

Symptom reduction one year postpartum in 10% of women with urinary incontinence or symptoms of pelvic organ prolapse using a pessary compared to women with symptoms without using a pessary. Six weeks postpartum, all study participants will be asked to take an online survey on pelvic floor symptoms. For this purpose, the validated pelvic floor questionnaire for postpartum women will be applied (Metz, et al 2017). The study participants who decided to use the pessary will be informed when to start. Two weeks after they started using the pessary, these study participants will be asked to take an online survey on the use and comfort of the pessary (Beilecke K et al 2017, Baessler K et al 2011). Three months, six months and one year postpartum another survey on the use of the pessary will take place. One year postpartum, all participants will be asked to answer again and for the very last time the online survey on pelvic floor symptoms.

—

Secondary

Measure	Time frame
Compliance of women with urinary incontinence or symptoms of pelciv organ prolapse to wear a pessary for at least 3 months postpartum.	—

Countries

Germany

Contacts

Public ContactMelanie Metz

Vivantesklinikum im FriedrichshainKlinik für Gynäkologie und Geburtshilfe

melanie.metz@vivantes.de+4930 130231442

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 6, 2026