Pelvic floor disorder
Conditions
Interventions
group A:laparoscopic inguinal ligament hysteropexy
group B:Sacrocolpopexy
Sponsors
Shanghai First Maternity and Infant Hospital
Eligibility
Sex/Gender
Female
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Ages Eligible for Study from 18 Years to 80 Years; 2. Subject has been diagnosed with uterine prolapse or posthysterectomy vaginal vault prolapse (symptomatic POP-Q stage III or higher) requiring surgical repair; 3. Subject has no uncontrolled systemic disease; 4. Subject is unwilling or unable to give valid informed consent.
Exclusion criteria
Exclusion criteria: 1. Investigator determines subject is not a candidate for surgical repair of her genital prolapse (lack of symptomatic or imaging basis; 2. Subject has active or latent systemic disease (including server liver diseasekidney diseaserespiratory diseasecardiovascular diseaseepilepsy or uncontrolled diabetes; 3. Subject is currently pregnant or intends to become pregnant during the study period; 4. Subject has gynecological or other cancer; 5. Subject is on any medication with could result in compromised immune response, such as immune modulators; 6. Subject is unwilling or unable to give valid informed consent; 7. Subject is unwilling or unable to comply with the requirements of the protocol, complete all quality of Life questionnaires and return for all follow-up visits; 8. Subject with contraindications for laparoscopy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| POP-Q;pelvic MRI; | — |
Countries
China
Contacts
Public ContactZhiyuan Dai
Outcome results
None listed