SAVE U -trial: Sacrospinous fixation versus vaginal hysterectomy in treatment of a uterine prolapse stage ≥ 2: a multi-center randomised controlled trial.

Sacrospinous fixation versus vaginal hysterectomy in treatment of a uterine prolapse stage ≥ 2: a multi-center randomised controlled trial.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON26877

Enrollment

208

Registered

2009-06-18

Start date

2009-08-01

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

None listed

Interventions

Random allocation to sacrospinous fixation or vaginal hysterectomy.

Eligibility

Inclusion criteria

Inclusion criteria: POP-Q stage ≥ 2 uterine descent requiring surgery. Patients with co-existing anterior / posterior defects or concomitant incontinence surgery (TVT-O) can be included too.

Exclusion criteria

Exclusion criteria: 1. Previous pelvic floor or prolapse surgery; 2. Known malignancy or abnormal cervical smears; 3. Wish to preserve fertility; 4. Unwilling to return for follow-up or language barriers; 5. Presence of immunological / haematological disorders interfering with recovery after surgery; 6. Abnormal ultrasound findings of uterus or ovaries, or abnormal uterine bleeding.

Design outcomes

Primary

Measure	Time frame
Surgical failure, defined as recurrence of prolapse POP-Q stage 2 of the middle compartment and prolapse complaints and/or redo surgery.	—

Secondary

Measure	Time frame
Secondary outcomes are subjective improvement on urogenital symptoms and quality of life (assessed by disease-specific and quality of life questionnaires), complications following surgery, hospital stay, post-operative recovery and sexual functioning.	—

Contacts

Public ContactR.J. Detollenaere

Postbus 10400

r.j.detollenaere@isala.nl+31 (0)38 424 7415

Outcome results