Back to resultsComparison of Two Apical Repair Methods in Women Undergoing Repairs for Prolapse
Primary Purpose
Pelvic Organ Prolapse, Surgery, Quality of Life
Status
Recruiting
Phase
Not Applicable
Locations
Austria
Study Type
Interventional
Intervention
fixation of the vaginal apex
Sponsored by
About this trial
This is an interventional treatment trial for Pelvic Organ Prolapse
Eligibility Criteria
Inclusion Criteria:
- declined/ failed conservative treatment for POP
- planned vaginal hysterectomy with anterior/posterior colporrhaphy as indicated
- any symptomatic POP or stage II prolapse in any compartment
- at least stage I prolapse in the apical department
- women between 35 and 80 years of age
- good German language skills
- any concomitant prolapse surgery (anterior, posterior vaginal repair, suburethral tapes) as indicated
- concomitant salpingo-oophorectomy if indicated
Exclusion Criteria:
- Unwillingness to participate
- Neurological disorders
- Previous hysterectomy
- Desire to have children
- Connective tissue disorders (i.e. Ehlers-Danlos syndrome, Marfan syndrome)
Sites / Locations
- MUGRAZRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
McCall culdoplasty
Sacrospinous ligament fixation
Arm Description
The McCall culdoplasty will be performed in a modified version as described by McCall in 1957. Specifically, two long acting bioresorbable sutures are put through the specific anatomic landmarks.
The SLF technique will be performed as described by Richter et al (Amreich, 1951). Two long acting bioresorbable sutures are passed through the right sacrospinous ligament and then fixed to the vaginal cuff.
Outcomes
Primary Outcome Measures
Number of patients with stage 2 or higher on the Pelvic Organ Prolapse Quantification System (POP-Q).
POP-Q stage 2 or higher means any point of the POP-Q system being -1 related to the hymen or below
Secondary Outcome Measures
Subjective cure
determined by the Patient Global Impression of Improvement (PGII) index
Quality of life as determined by a questionnaire
The Kings Health Questionnaire was validated in women with stress urinary incontinence and assesses the impact of incontinence on quality of life. The eight subscales ("domains") scored between 0 (best) and 100 (worst). The Symptom Severity scale is scored from 0 (best) to 30 (worst); lower scores indicate better QoL. Success in terms of the study is defined as 10 points improvement on the total Kings Health Questionnaire score.
Sexual health
The Pelvic Organ Prolapse Incontinence Sexual Questionnaire is a 20 item questionnaire and is the primary measure used to assess sexual function in women with urinary incontinence and prolapse. Mean subscale scores are calculated by summing the valid responses to items in the subscale and then divided by the number of items with valid responses. The higher the subscores, the worse the outcome.
Reoperation rate
Number of patients with any reoperations for POP
Full Information
NCT ID
NCT03113513
First Posted
April 10, 2017
Last Updated
April 5, 2022
Sponsor
Medical University of Graz
1. Study Identification
Unique Protocol Identification Number
NCT03113513
Brief Title
Comparison of Two Apical Repair Methods in Women Undergoing Repairs for Prolapse
Official Title
Randomized Trial of Sacrospinous Ligament Fixation Versus McCall Culdoplasty in Women Undergoing Vaginal Hysterectomy and Repairs for Prolapse
Study Type
Interventional
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Recruiting
Study Start Date
May 1, 2016 (Actual)
Primary Completion Date
April 30, 2023 (Anticipated)
Study Completion Date
April 30, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medical University of Graz
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
To date no study has determined prospectively which technique is superior to prevent recurrent Pelvic Organ Prolapse (POP) after vaginal hysterectomy- a major unmet clinical need. The aim of the study is to determine objective anatomical recurrent prolapse after Sacrospinous Ligament Fixation (SLF) vs McCall.
Detailed Description
The aim of the study is to determine objective anatomical recurrent prolapse after SLF vs McCall. The study is designed as a Randomized Controlled Trial (RCT). Primary study endpoint will be at 12 months, secondary study endpoint at 24 months. The following parameters will be evaluated after one year: anatomical outcome, Quality of Life (QoL), sexual health, reoperations, and complications.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pelvic Organ Prolapse, Surgery, Quality of Life, Complication
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
The study is designed as a RCT.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
312 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
McCall culdoplasty
Arm Type
Active Comparator
Arm Description
The McCall culdoplasty will be performed in a modified version as described by McCall in 1957. Specifically, two long acting bioresorbable sutures are put through the specific anatomic landmarks.
Arm Title
Sacrospinous ligament fixation
Arm Type
Active Comparator
Arm Description
The SLF technique will be performed as described by Richter et al (Amreich, 1951). Two long acting bioresorbable sutures are passed through the right sacrospinous ligament and then fixed to the vaginal cuff.
Intervention Type
Procedure
Intervention Name(s)
fixation of the vaginal apex
Intervention Description
In the course of vaginal hysterectomy the vaginal cuff is either fixed to the sacrospinous ligament or to the uterosacral ligament.
Primary Outcome Measure Information:
Title
Number of patients with stage 2 or higher on the Pelvic Organ Prolapse Quantification System (POP-Q).
Description
POP-Q stage 2 or higher means any point of the POP-Q system being -1 related to the hymen or below
Time Frame
12 months after surgery
Secondary Outcome Measure Information:
Title
Subjective cure
Description
determined by the Patient Global Impression of Improvement (PGII) index
Time Frame
12 months after surgery
Title
Quality of life as determined by a questionnaire
Description
The Kings Health Questionnaire was validated in women with stress urinary incontinence and assesses the impact of incontinence on quality of life. The eight subscales ("domains") scored between 0 (best) and 100 (worst). The Symptom Severity scale is scored from 0 (best) to 30 (worst); lower scores indicate better QoL. Success in terms of the study is defined as 10 points improvement on the total Kings Health Questionnaire score.
Time Frame
12 months after surgery
Title
Sexual health
Description
The Pelvic Organ Prolapse Incontinence Sexual Questionnaire is a 20 item questionnaire and is the primary measure used to assess sexual function in women with urinary incontinence and prolapse. Mean subscale scores are calculated by summing the valid responses to items in the subscale and then divided by the number of items with valid responses. The higher the subscores, the worse the outcome.
Time Frame
12 months after surgery
Title
Reoperation rate
Description
Number of patients with any reoperations for POP
Time Frame
12 months after surgery
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
only women are included into the study
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
declined/ failed conservative treatment for POP
planned vaginal hysterectomy with anterior/posterior colporrhaphy as indicated
any symptomatic POP or stage II prolapse in any compartment
at least stage I prolapse in the apical department
women between 35 and 80 years of age
good German language skills
any concomitant prolapse surgery (anterior, posterior vaginal repair, suburethral tapes) as indicated
concomitant salpingo-oophorectomy if indicated
Exclusion Criteria:
Unwillingness to participate
Neurological disorders
Previous hysterectomy
Desire to have children
Connective tissue disorders (i.e. Ehlers-Danlos syndrome, Marfan syndrome)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Daniela Gold (prev. Ulrich), MD PhD
Phone
0043316385
Ext
81437
Email
daniela.gold@medunigraz.at
Facility Information:
Facility Name
MUGRAZ
City
Graz
State/Province
Styria
ZIP/Postal Code
8036
Country
Austria
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Daniela Gold (prev. Ulrich), MD PhD
Phone
0043316385
Ext
81437
Email
daniela.gold@medunigraz.at
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
The sponsor has access to all study relevant data. In the specific centers only authorized study personnel has access to the data.
Citations:
PubMed Identifier
9704759
Citation
Colombo M, Milani R. Sacrospinous ligament fixation and modified McCall culdoplasty during vaginal hysterectomy for advanced uterovaginal prolapse. Am J Obstet Gynecol. 1998 Jul;179(1):13-20. doi: 10.1016/s0002-9378(98)70245-5.
Results Reference
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Comparison of Two Apical Repair Methods in Women Undergoing Repairs for Prolapse
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