Clinical trial NCT05189665: the Anatomical Reduction and Functional Recovery Effects of Two Transvaginal Apical Slings on Pelvic Organ Prolapse
Official title: A Randomized Controlled Study on the Anatomical Reduction and Functional Recovery Effects of Two Transvaginal Apical Slings on Pelvic Organ Prolapse
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pelvic Organ Prolapse
Keywords: Extraperitoneal high uterosacral ligament suspension
Lead sponsor: Peking University People's Hospital
Sponsor class: OTHER
First posted: 2022-01-12
Enrollment: 124
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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).

Eligibility 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.

Primary outcomes:
measure: changes in POP-Q score at different time nodes
timeFrame: pre-operation and post-operation(at 1month, 3 month, 6 month and a year)
Secondary outcomes:
measure: UDI-6 scores at different time nodes UDI-6
timeFrame: pre-operation and post-operation(at 1month, 3 month, 6 month and a year)
measure: Postoperative urinary incontinence assessment
timeFrame: post-operation(at 1month, 3 month, 6 month and a year)
measure: OABss score at different time nodes
timeFrame: post-operation(at 1month, 3 month, 6 month and a year)
measure: PFDI-20 score at different time nodes
timeFrame: post-operation(at 1month, 3 month, 6 month and a year)
measure: ICIQ-SF score at different time nodes
timeFrame: post-operation(at 1month, 3 month, 6 month and a year)
measure: I-QoL score at different time nodes
timeFrame: post-operation(at 1month, 3 month, 6 month and a year)
measure: PISQ-12 score at different time nodes
timeFrame: post-operation(at 1month, 3 month, 6 month and a year)
measure: PFIQ-7 score at different time nodes
timeFrame: post-operation(at 1month, 3 month, 6 month and a year)
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University People's Hospital
state: Beijing
Study officials:
affiliation: Beijing Key Laboratory of Female Pelvic Floor Disorders
name: xiuli sun, professor
role: STUDY_CHAIR
References: