the Anatomical Reduction and Functional Recovery Effects of Two Transvaginal Apical Slings on Pelvic Organ Prolapse

Peking University

Status: Unknown

Conditions: Pelvic Organ Prolapse

Treatments: Procedure: Extraperitoneal high sacral ligament suspension surgery; Procedure: Sacrospinous ligament fixation

Study type: Interventional

Funder types: Other

Identifiers

NCT05189665

Pkuh4

Details and patient eligibility

About

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.

Full 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).

Enrollment: 124 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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124 participants in 2 patient groups

Extraperitoneal high sacral ligament suspension Group

Experimental group

Description:

We will recruit 62 POP patients ,and perform Surgery Extraperitoneal high sacral ligament suspension surgery on them.

Treatment:

Procedure: Extraperitoneal high sacral ligament suspension surgery

Sacrospinous Ligament Suspension Group

Active Comparator group

Description:

We will recruit 62 POP patients ,and perform sacrospinous ligament suspension surgery on them.

Treatment:

Procedure: Sacrospinous ligament fixation