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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02290288
Recruitment Status : Completed
First Posted : November 14, 2014
Last Update Posted : May 19, 2015
Sponsor:
Information provided by (Responsible Party):
Janusz Marcickiewicz, Sahlgrenska University Hospital, Sweden

Brief 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.

Condition or disease Intervention/treatment Phase
Vaginal Vault Prolapse Procedure: vaginal surgery Procedure: laparoscopic surgery Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 138 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Prospective Randomized Study for Vaginal Vault Prolapse After Hysterectomy: Comparison of a Vaginal and Laparoscopic Method With Validation of Translated Questionnaire for Symptoms and Quality of Life by Vaginal Prolapse.
Study Start Date : October 2005
Actual Primary Completion Date : May 2015
Actual Study Completion Date : May 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hysterectomy

Arm Intervention/treatment
Active Comparator: SSF
1. vaginal surgery arm (SSF)
Procedure: vaginal surgery
Active Comparator: LSC
laparoscopic surgery arm (LSC)
Procedure: laparoscopic surgery



Primary Outcome Measures :
  1. anatomical failure (Failure was defined clinically as Ba, C or Bp at the hymen or below, on maximum Valsalva maneuver.) [ Time Frame: 1 year ]
    The primary outcome measure was anatomical failure based on clinical assessment. Failure was defined clinically as Ba, C or Bp at the hymen or below, on maximum Valsalva maneuver.


Secondary Outcome Measures :
  1. continence status [ Time Frame: 1 and 5 years ]
    continence status based on validated questionnaires: Pelvic Floor Impact Questionnaire (PFIQ - 7), Pelvic Floor Distress Inventory Questionnaire - Short Form 20 (PFDI-20), Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-12)

  2. sexual function [ Time Frame: 1 and 5 years ]
    sexual function based on validated questionnaires: Pelvic Floor Impact Questionnaire (PFIQ - 7), Pelvic Floor Distress Inventory Questionnaire - Short Form 20 (PFDI-20), Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-12)

  3. prolapse symptoms [ Time Frame: 1 and 5 years ]
    symptoms based on validated questionnaires: Pelvic Floor Impact Questionnaire (PFIQ - 7), Pelvic Floor Distress Inventory Questionnaire - Short Form 20 (PFDI-20), Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-12

  4. quality of life [ Time Frame: 1 and 5 years ]
    quality of life based on validated questionnaires: Pelvic Floor Impact Questionnaire (PFIQ - 7), Pelvic Floor Distress Inventory Questionnaire - Short Form 20 (PFDI-20), Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-12) and quality of life based on Short Form (36) Health Survey.



Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • post-hysterectomy patients with at least two-compartment prolapse (with affected apical/vault compartment,
  • stage II or higher on the Pelvic Organ Prolapse Quantification system (POP-Q)),
  • suffering from symptoms of prolapse,
  • requesting pelvic floor reconstructive surgery, and
  • diagnosed with a vault prolapse.

Exclusion Criteria:

  • patients with prolapse and uterus in place,
  • those not requesting pelvic floor surgery,
  • patients who do not understand Swedish or are not capable to fulfill follow up procedure

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02290288


Locations
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Sweden
Dept of Obst Gyn, Sahlgrenska University Hospital
Gothenburg, VGR, Sweden, 41381
Sponsors and Collaborators
Sahlgrenska University Hospital, Sweden
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Responsible Party: Janusz Marcickiewicz, senior consultant, Sahlgrenska University Hospital, Sweden
ClinicalTrials.gov Identifier: NCT02290288    
Other Study ID Numbers: VGFOUREG-28601
First Posted: November 14, 2014    Key Record Dates
Last Update Posted: May 19, 2015
Last Verified: May 2015
Additional relevant MeSH terms:
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Prolapse
Pelvic Organ Prolapse
Pathological Conditions, Anatomical