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

Recruiting

• Conditions: prolapse; uterine descent; 10046828

• Registration Number: NL-OMON35140
• Lead Sponsor: Isala Klinieken

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 6 May 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 198

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

Exclusion Criteria

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary outcome: anatomical outcome and recurrence rate assessed by a<br /><br>POP-Q-test.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary outcomes are subjective improvement on urogenital symptoms and<br /><br>quality of life (assessed by disease-specific and quality of life<br /><br>questionnaires), complications following surgery, hospital stay, post-operative<br /><br>recovery, sexual functioning and costs. </p><br>