the Anatomical Reduction and Functional Recovery Effects of Two Transvaginal Apical Slings on Pelvic Organ Prolapse
Study Details
Study Description
Brief Summary
The study is a prospective study at a single institution. Investigators create strict inclusion and exclusion criteria, selecting 124 patients with POP(≥II degree and have symptoms that need operation) . 62 patients in the intervention group accept extraperitoneal high uterosacral ligament suspension. The other 62 patients in the other group accept sacrospinous ligament suspension.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
Investigators evaluate all women's operation method, operation time, bleed volume, overactive bladder questionnaire, PFDI-20，ICIQ-SF, I-QoL, PISQ-12, PFIQ-7, UDI-6, pre- and post-operation (at 1 month, 3 months, 6months and 1 year).
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Extraperitoneal high sacral ligament suspension Group We will recruit 62 POP patients ,and perform Surgery Extraperitoneal high sacral ligament suspension surgery on them. |
Procedure: Extraperitoneal high sacral ligament suspension surgery
The extraperitoneal high sacral ligament suspension surgery is to shorten the bilateral uterosacral ligaments .
|
| Active Comparator: Sacrospinous Ligament Suspension Group We will recruit 62 POP patients ,and perform sacrospinous ligament suspension surgery on them. |
Procedure: Sacrospinous ligament fixation
The sacrospinous ligament fixation surgery is to open the front and back peritoneum through the vagina and shorten the bilateral uterosacral ligaments.
|
Outcome Measures
Primary Outcome Measures
- changes in POP-Q score at different time nodes [pre-operation and post-operation(at 1month, 3 month, 6 month and a year)]
Gynecological examination
Secondary Outcome Measures
- UDI-6 scores at different time nodes UDI-6 [pre-operation and post-operation(at 1month, 3 month, 6 month and a year)]
Questionnaires on lower urinary tract symptoms and quality of life
- Postoperative urinary incontinence assessment [post-operation(at 1month, 3 month, 6 month and a year)]
One hour pad test
- OABss score at different time nodes [post-operation(at 1month, 3 month, 6 month and a year)]
Questionnaires lower urinary tract symptoms
- PFDI-20 score at different time nodes [post-operation(at 1month, 3 month, 6 month and a year)]
Questionnaires on pelvic floor function and lower urinary tract symptoms and quality of life
- ICIQ-SF score at different time nodes [post-operation(at 1month, 3 month, 6 month and a year)]
Questionnaires on lower urinary tract symptoms
- I-QoL score at different time nodes [post-operation(at 1month, 3 month, 6 month and a year)]
Questionnaires on lower urinary tract symptoms and quality of life
- PISQ-12 score at different time nodes [post-operation(at 1month, 3 month, 6 month and a year)]
Questionnaires on pelvic floor function and lower urinary tract symptoms and sexual quality of life
- PFIQ-7 score at different time nodes [post-operation(at 1month, 3 month, 6 month and a year)]
Questionnaires on pelvic floor function and quality of life
Eligibility Criteria
Criteria
Inclusion Criteria:
Age ≥30 years old;
pelvic organ prolapse, with or without abnormal urination or defecation or sexual disturbance, which affects the quality of life
Pelvic organ prolapse quantitation (POP-Q) is greater than or equal to Those who are in stage II and have symptoms and require surgery
The patient agrees to conduct the study and can be followed up on time.
Exclusion Criteria:
Those who cannot tolerate surgery and anesthesia
Those who need to remove the uterus
Those who have removed the uterus
Those who cannot be followed up on time.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Peking University People's Hospital | Beijing | Beijing | China | 100044 |
Sponsors and Collaborators
- Peking University People's Hospital
Investigators
- Study Chair: xiuli sun, professor, Beijing Key Laboratory of Female Pelvic Floor Disorders
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- Pkuh4