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Prospective Study for Vaginal Vault Prolapse After Hysterectomy: Comparison of Two Surgical Methods

NCT02290288 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 138

Last updated 2015-05-19

No results posted yet for this study

Summary

The study is carried out at the Sahlgrenska University Hospital and the patient population consists of women referred with symptomatic and bothersome post-hysterectomy vaginal vault prolapse at least 1 cm above or beyond the hymeneal remnants. The interventions are either vaginal sacrospinousfixation or laparoscopic sacrocolpopexy following randomization to one of the types of surgery. The primary outcome is anatomical failure based on clinical assessment. Failure is defined clinically, according to the Pelvic Organ Prolapse Quantification system, as Ba, C or Bp at the hymen or below on maximum Valsalva maneuver one and two years after the surgery. Secondary outcomes are evaluation of continence, sexual function and prolapse symptoms based on validated questionnaires 1, 2, 5 and 10 years after the surgery.

Conditions

  • Vaginal Vault Prolapse

Interventions

PROCEDURE

vaginal surgery

PROCEDURE

laparoscopic surgery

Sponsors & Collaborators

  • Sahlgrenska University Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
40 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-10-31
Primary Completion
2015-05-31
Completion
2015-05-31

Countries

  • Sweden

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02290288 on ClinicalTrials.gov