Evaluation of two vaginal, uterussparing surgical methods for pelvic organ prolapse reconstruction: modified Manchester operation (MM) and sacrospinal hysteropexy (SSH).

Recruiting

• Conditions: pelvic organ prolapse; vaginal descent; 10047789; 10029903

• Registration Number: NL-OMON54613
• Lead Sponsor: Academisch Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 23 April 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 424

Inclusion Criteria

Women with symptomatic pelvic organ prolapse including uterine descent. The
prolapse may be at any stage but POP-Q point D may not exceed minus 1cm.
Community dwelling
Capable of filling out questionnaires
Patients from the hospitals in Nijmegen, Zwolle, Almelo, Hengelo and Enschede)
are asked to participate in a supine and upright MRI scan at the University of
Twente.

Exclusion Criteria

- < 18 years
- Previous prolapse or other pelvic floor surgery Previous POP surgery
- Previous incontinence surgery
- POP-Q longer than 3 months ago at randomisation
- Need or wish for removal of the uterus
- Need for concomitant mid-urethral sling surgery
- Contraindication to uterus preservation (in case indicated, a pap-smear
and/or pipelle endometrial biopsy should be normal before inclusion)
- Pregnancy or future wish for childbearing
- Insufficient understanding and reading of the Dutch language
- Not capable of filling out questionnaires
For the facultative MRI study additional exclusion criteria are in order,
namely:
- Inability to stand for 15 minutes without assistance
- Hip width> 47cm (jeans size >44)
- Not allowed to do a maximum Valsalva manoeuvre because of cardiac or
pulmonary disease
- Not eligible for MRI, in response to the MRI safety checklist

Study & Design

• Study Type: Interventional
• Study Design: Not specified