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Study on shared decision making in choosing a treatment for pelvic organ prolapse

A Delphi study for the development of a web-based Decision Aid for the treatment of symptomatic pelvic organ prolapse followed by a cluster Randomized Controlled Trial on use of the Decision Aid

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON27378
Enrollment
415
Registered
2016-10-30
Start date
2016-12-01
Completion date
Unknown
Last updated
2024-02-28

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

Conditions

Pelvic organ prolapse, cystocele, rectocele, enterocele, uterine descent, surgery, pessary, treatment

Interventions

In the intervention group, patients will be presented with the decision aid after diagnosis. After completing the web-based decision aid program, patients’ preferences will be discussed with the clini

Sponsors

Elisabeth TweeSteden Ziekenhuis Tilburg, Universiteit van Tilburg, Zorgkeuzelab
Lead Sponsor

Eligibility

Age
18 Years to 64 Years

Inclusion criteria

Inclusion criteria: 1. Woman with a symptomatic prolapse 2. Woman for whom a (new) treatment must be chosen. Patients are eligible for at least two treatment options 3. Patients have to be able to make use of a computer with internet access in order to make use of the web-based decision aid and to complete the online questionnaires 4. Written informed consent

Exclusion criteria

Exclusion criteria: 1. Patients with a history of gynaecological cancer 2. Patients and clinicians who do not have any access to the internet 3. Patients and clinicians who do not have sufficient knowledge of the Dutch language 4. More than 1 POP-surgery in the past or POP-surgery < 2 years. Anti-incontinence surgery is not considered POP surgery here. 5. In case of a second opinion, the patient will not be included if the first opinion was obtained in one the hospitals involved in the study 6. Patients participating in the PEOPLE study

Design outcomes

Primary

MeasureTime frame
The main study endpoints are: satisfaction with treatment decision (making), and satisfaction with information.

Secondary

MeasureTime frame
Secondary endpoints are satisfaction with care and treatment, decisional conflict and decisional regret, quality of life, healthcare providers’ evaluation of the (implementation of the) decision aid, and recurring symptomatic POP.

Contacts

Public ContactL.E. Drost

St. Elisabeth Hospital Tilburg, Hilvarenbeekseweg 60

l.drost@erasmusmc.nl

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)