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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| McCall culdoplasty | Active Comparator | 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. |
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| Sacrospinous ligament fixation | Active Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| fixation of the vaginal apex | Procedure | In the course of vaginal hysterectomy the vaginal cuff is either fixed to the sacrospinous ligament or to the uterosacral ligament. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 | 12 months after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Subjective cure | determined by the Patient Global Impression of Improvement (PGII) index | 12 months after surgery |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
only women are included into the study
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| MUGRAZ | Graz | Styria | 8036 | Austria |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 9704759 | Background | 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. |
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The sponsor has access to all study relevant data. In the specific centers only authorized study personnel has access to the data.
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| ID | Term |
|---|---|
| D056887 | Pelvic Organ Prolapse |
| ID | Term |
|---|---|
| D011391 | Prolapse |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
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The study is designed as a RCT.
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| 12 months after surgery |
| 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. | 12 months after surgery |
| Reoperation rate | Number of patients with any reoperations for POP | 12 months after surgery |