Primary treatment of vaginal prolapse: Pessary use versus prolapse surgery.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON24754

Enrollment

Registered

2011-04-17

Start date

2010-01-01

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

English: Pelvic Organ Prolapse Pessary Prolapse surgery Dutch: Prolaps Verzakking Pessarium Ring Prolapschirurgie

Interventions

Pessary: 1. Portex

2. Falk. Prolapse surgery: 1. Vaginal hysterectomy

2. Anterior colporrhaphy

3. Posterriorcolporrhaphy

4. A combination of above-mentioned surgical treatments

5. A combination of above-mentioned surgical treatments including MESH material.

Eligibility

Inclusion criteria

Inclusion criteria: 1. POP-Q stage grade 2-4 (POP-Q according to ICS); 2. Eligible for pessary treatment and prolapse surgery.

Exclusion criteria

Exclusion criteria: 1. Isolated rectocele; 2. Previous prolapse treatment; 3. Previous treatment against urine incontinence.

Design outcomes

Primary

Measure	Time frame
The primary outcome will be disease specific quality of life, which will be evaluated by using the urogenital distress inventory (UDI).	—

Secondary

Measure	Time frame
1. General quality of life and patients satisfaction rate. Both will be evaluated by using a validated questionnaire (werkgroepbekkenbodem, eurqol, SF-36); 2. Successful continuous pessary treatment; 3. Anatomical result. Evaluated through pelvic examination according to the recommendations of the ICS.	—

Contacts

Public ContactA.L.W.M. Coolen

Polikliniek gynaecologie, tav A.Coolen Postbus 7777

a.coolen@mmc.nl

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)