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Completed

NCT Number: NCT05697796

Comparison of Post-operative Symptoms After Two Surgeries for Patients With Pelvic Organ Prolapse

Collect and review the patients who underwent surgical treatment due to pelvic floor organ prolapse from 2020 to 2021, make statistics on their postoperative questionnaire data, and evaluate the clinical effects of different surgical methods

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Key information

Conditions

Pelvic Organ Prolapse Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Prolapse

Age range

30 year and older

Sex eligibility

Female

Study type

Observational

Primary location

The Peking University People's Hospital

Beijing, Beijing Municipality, 100044, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age ≥ 30 years;
  • Because pelvic organ prolapse in our hospital, we performed extraperitoneal high sacral ligament suspension or sacrospinal ligament fixation; ③ Those who have no surgical contraindication and can tolerate surgery and anesthesia.

Exclusion criteria

  • Those who cannot tolerate surgery and anesthesia; ② Patients receiving other tip suspension techniques.

Treatment and study plan

Two different surgical methods

Procedure

SSLF：sacrospinal ligament fixation EHUS：Extraperitoneal high sacral ligament suspension

Primary outcomes

  1. changes in POP-Q score at different time nodes

    Time frame: pre-operation and post-operation(1month, 3 months and 6 months )

    Gynecological examination

Secondary outcomes

  1. UDI-6 scores at different time nodes

    Time frame: pre-operation and post-operation(1month, 3 months and 6 months )

    Questionnaires on lower urinary tract symptoms and quality of life

  2. PFDI-20 scores at different time nodes

    Time frame: pre-operation and post-operation(1month, 3 months and 6 months )

    Questionnaires on lower urinary tract symptoms and quality of life

  3. OABss scores at different time nodes

    Time frame: pre-operation and post-operation(1month, 3 months and 6 months )

    Questionnaires on lower urinary tract symptoms

Sponsors and collaborators

Lead sponsor

Peking University People's Hospital

Other

Registry information

Official study title

Comparison of Post-operative Lower Urinary Tract Symptoms After Sacrospinous Ligament Fixation or Extraperitoneal High Uterosacral Ligament Suspension for Patients With Pelvic Organ Prolapse

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Jan 26, 2023
Registry last updated
Jan 26, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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