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Sacrospinous ligament fixation combined with cystocele repair versus Elevate Anterior procedure in treatment of primary prolapse.

Sacrospinous ligament fixation combined with anterior colporrhaphy versus Elevate Anterior procedure in treatment of primary apical and anterior compartment prolapse stage 2 or more: A multi-center randomised controlled trial.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON25045
Enrollment
100
Registered
2011-09-19
Start date
2012-05-01
Completion date
Unknown
Last updated
2024-06-11

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

Conditions

Pelvic organ prolapse. Surgery. Mesh. Recurrence. Sexual Function. Vaginale verzakking. Chirurgie. Mesh/implantaat. Recidief. Seksuele functie.

Interventions

Elevate Anterior or sacrospinous ligament fixation combined with anterior colporrhaphy.

Sponsors

University Medical Center
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Sexually active women with a primary apical and anterior compartment prolapse stage 2 or more requiring surgery. Patients with co-existing posterior defects or concomitant perineal surgery (perineoplasty) can be included

Exclusion criteria

Exclusion criteria: 1. Previous prolapse surgery; 2. Enterocele stage 2 or more after hysterectomy (performed for other reasons than prolapse); 3. Known malignancy; 4. Pregnancy or wish to become pregnant; 5. Unwilling to return for follow-up or language barriers; 6. Presence of immunological / haematological disorders interfering with recovery after surgery; 7. Abnormal ultrasound findings of uterus or ovaries.

Design outcomes

Secondary

MeasureTime frame
Sexual function measured using the PISQ-12, POP-Q, morbidity (including post-operative pain, complications and recovery of normal daily activities), generic quality of life, repeated pelvic floor surgery within 12 months after intervention and cost analysis.

Primary

MeasureTime frame
Quality of life related to pelvic floor function at one year after intervention measured using UDI, DDI and IIQ questionnaires.

Contacts

Public ContactJan-Paul W.R. Roovers

PO Box 22660

j.p.roovers@amc.uva.nl+31 (0)20 5666429

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)