Pelvic Organ Prolapse
Conditions
Keywords
pelvic organ prolapse, pectopexy, laparoscopy, uterosacral ligaments plication
Brief summary
The investigators planned to measure the effectiveness of laparoscopic pectopexy in apical prolapse and whether the addition of sacrouterine ligaments plication to pectopexy increases the effectiveness of pectopexy operation. Investigators planned to measure patients' quality of life using the female sexual function scale test 3, 6 and 12 months after the surgery and to determine how the operation affects the quality of sexual life.
Detailed description
In this study, the investigators planned to measure the effectiveness of laparoscopic pectopexy in apical prolapse and whether the addition of sacrouterine ligaments plication to pectopexy increases the effectiveness of pectopexy operation. Investigators planned to measure patients' quality of life using the female sexual function scale test 3, 6 and 12 months after the surgery and to determine how the operation affects the quality of sexual life.
Interventions
PROCEDUREpectopexy operation
Vaginal cuff or uterine cervix will be attached to iliopectineal ligament with polypropylene mesh on both sides.
PROCEDUREuterosacral ligaments plication operation.
At least 2/3 of the sacrouterine ligaments will be shortened with helical sutures, starting from the cervix and so douglas will be partially obliterated.
Sponsors
Ataturk University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
25 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* patients with stage II-IV apical compartment defect according to the POP-Q classification
Exclusion criteria
* having severe chronic disease that makes the operation dangerous * patients under 25 and patients over 75 years old
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| questionnaire of lower urinary tract symptoms | changes in symptoms for each title at the preoperative day 1 and postoperative day 3 period | the questionaire examines these titles by scoring from one to ten points: 1. sudden feeling of ürination 2. sudden feeling of urination with incontinence 3. Frequent urination 4. Difficulty of starting the urination 5. Abnormal discharge of urine 6. nocturia 7. dyspareunia 8. Stress urinary incontinence 9. dysuria 10. constipation |
| evaluation of sexual function with Women's Sexual Function Index | changes at the preoperative day 1 and postoperative day 40 period | Women's Sexual Function Index is a questionnaire about sexual functions of the women. the index definex sexual functions with some questions and scorings. |
| Stage of apical compartment defect according to the Pelvic Organ Prolapse (POP-Q) classification | changes in the stage of apical compartment defect at the preoperative day 1 and postoperative day 3 period according to POP-Q clasification | Stage of apical compartment defect according to the Pelvic Organ Prolapse (POP-Q) classification |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| evaluation of sexual function with Women's Sexual Function Index | changes at 3,6 and 12. month after surgery | Women's Sexual Function Index is a questionnaire about sexual functions of the women. the index definex sexual functions with some questions and scorings. |
| Stage of apical compartment defect according to the Pelvic Organ Prolapse (POP-Q) classification | changes at 3,6 and 12. month after surgery | Stage of apical compartment defect according to the Pelvic Organ Prolapse (POP-Q) classification |
| questionnaire of lower urinary tract symptoms | changes in symptoms for each title at 3,6 and 12. month after surgery | the questionaire examines these titles by scoring from one to ten points: 1. sudden feeling of ürination 2. sudden feeling of urination with incontinence 3. Frequent urination 4. Difficulty of starting the urination 5. Abnormal discharge of urine 6. nocturia 7. dyspareunia 8. Stress urinary incontinence 9. dysuria 10. constipation |
Countries
Turkey (Türkiye)
Outcome results
None listed