SUperiority of Perineoplasty as concomitant surgical procedure during Pelvic Organ prolapse Repair: a comparative cohort Trial (SUPPORT)

SUperiority of Perineoplasty as concomitant surgical procedure during Pelvic Organ prolapse Repair: a comparative cohort Trial (SUPPORT) - SUPPORT

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON51797

Enrollment

288

Registered

2023-01-18

Start date

2023-03-24

Completion date

Unknown

Last updated

2025-09-15

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

Conditions

prolapse

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Patients >18 years indicated for vaginal POP surgery Inlcusion criteria: 1. Female patient> 18 years of age 2. Complaints of pelvic organ prolapse 3. Indication for vaginal native tissue prolapse surgery (level I and/or level II repair) 4.Genital hiatus (GH) according to POP-Q staging of >=4 cm and

Exclusion criteria

Exclusion criteria: Exclusion criteria: 1. Unable to understand the Dutch language 2. Pregnancy at baseline or intendancy to become pregnant during the study period 3. Patients with previous surgery for POP (previous mid urethral sling operation for stress urinary incontinence not excluded) 4. Unwilling to participate in the study and/or incapable of giving informed consent

Design outcomes

Primary

Measure	Time frame
Primary Outcome: Surgical success, which is a composite outcome defined as meeting the 3 following conditions: [1] much improved or improved in response to the patient global impression of improvement questionnaire, [2] no re-intervention performed in the same compartment within the first 12 months after index surgery, [3] no stage 2 or more POP in the operated compartment Secondary outcomes: Morbidity: complications and re-interventions due to complications	—

Measure

Time frame

Primary Outcome: Surgical success, which is a composite outcome defined as meeting the 3 following conditions: [1] *much improved* or *improved* in response to the patient global impression of improvement questionnaire, [2] no re-intervention performed in the same compartment within the first 12 months after index surgery, [3] no stage 2 or more POP in the operated compartment Secondary outcomes: Morbidity: complications and re-interventions due to complications

—

Secondary

Measure	Time frame
Secondary outcomes: Morbidity: complications and re-interventions due to complications, pain. Effectiveness: disease specific and general quality of life. Anatomical outcomes. Societal costs.	—

Countries

Netherlands

Outcome results