Pelvic Organ Prolapse Clinical Trial
— LULS-1Official title:
Short and Long-term Outcomes After Total Laparoscopic Hysterectomy With Vaginal Vault Suspension to the Uterosacral Ligaments Versus Vaginal Hysterectomy With McCall Culdoplasty for the Treatment of Stage II-III Pelvic Organ Prolapse.
NCT number | NCT03553511 |
Other study ID # | LULS-1 |
Secondary ID | |
Status | Not yet recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | May 2022 |
Est. completion date | May 2024 |
The International Continence Society defines post-hysterectomy vault prolapse (PHVP) as descent of the vaginal cuff scar below a point that is 2 cm less than the total vaginal length above the plane of the hymen. The incidence of PHVP has been reported to affect up to 43% of hysterectomies. The risk of prolapse following hysterectomy is 5.5 times more common in women whose initial hysterectomy was for pelvic organ prolapse as opposed to other reasons. Techniques available to manage PHVP aim to ultimately suspend the vaginal vault. Approaches include vaginal, e.g. uterosacral ligament suspension, sacrospinous ligament fixation, open procedures and more recently laparoscopic, e.g. sacrocolpopexy and uterosacral plication. Data published so far do not allow to draw a firm conclusion about the best treatment to prevent PHVP for women undergoing hysterectomy for stage II-III pelvic organ prolapse. Considering this scenario, in the current study the investigators aim to evaluate short and long-term outcomes after total laparoscopic hysterectomy with vaginal vault suspension to the uterosacral ligaments versus vaginal hysterectomy with McCall culdoplasty for the treatment of stage II-III pelvic organ prolapse.
Status | Not yet recruiting |
Enrollment | 60 |
Est. completion date | May 2024 |
Est. primary completion date | May 2023 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 65 Years |
Eligibility | Inclusion Criteria: - Stage II-III pelvic organ prolapse - Bilateral preservation of the ovaries - Sexually active women Exclusion Criteria: - Smoking - Body Mass Index > 30 - Strenuous activity (frequent heavy lifting) - Other gynecological and non-gynecological (chronic endocrine, metabolic, autoimmune, neoplastic diseases) comorbidities - Pharmacological and/or nonpharmacological treatment (including pelvic floor exercises) in the six months preceding the surgery or during the study period |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Università degli Studi dell'Insubria |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Recurrence | Vaginal vault prolapse | 12 months after surgery | |
Secondary | Urinary impact questionnaire score (total score minimum: 0, maximum: 100) | A specific questionnaire developed to investigate the impact of urinary symptoms and signs on the quality of life. | 12 months after surgery | |
Secondary | Pelvic Organ Prolapse Impact Questionnaire (total score minimum: 0, maximum: 100) | A specific questionnaire developed to investigate the impact of prolapse-related symptoms and signs on the quality of life. | 12 months after surgery | |
Secondary | Colorectal-Anal Impact questionnaire (total score minimum: 0, maximum: 100) | A specific questionnaire developed to investigate the impact of prolapse-related colorectal and anal symptoms and signs on the quality of life. | 12 months after surgery | |
Secondary | Prolapse/urinary incontinence sexual questionnaire score (total score minimum: 0, maximum: 48) | A specific questionnaire developed to investigate the impact of prolapse/urinary incontinence on sexual functions. | 12 months after surgery |
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