Clinical Trial: the Indications and Clinical Efficacy of Pelvic Organ Prolapse Surgery

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: The Clinical Efficacy of Pelvic Organ Prolapse Surgery

Brief Summary: One thousand patients with stage＞2 POP are recruited. The patients are all received surgeries,such as transvaginal synthetic mesh surgery, the sacral fixation, tissue repair surgery and colpocleisis. The patients with POP who have not undergone surgery are excluded. Postoperatively, the investigators investigate the indications and clinical efficacy of pelvic organ prolapse surgery.

Detailed Summary: Postoperatively, the investigators analyze the patients' subjective and objective recurrent rates. The investigators compare the quality of life by filling out the preoperative and postoperative scoring questionnaires (PISQ 12, PFDI-20, PFIQ-7).The electrical physiological changes will be focused on. The investigators also use Overactive Bladder Symptom Score(OABss) to assess the lower urinary tract symptoms.
Sponsor: Peking University People's Hospital

Current Primary Outcome: the objective recurrent rate [ Time Frame: one year after surgery ]

The objective recurrence means postoperative stage≥2 (POP-Q) in any compartment.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • the rate of the lower urinary tract symptoms [ Time Frame: one year after surgery ]
    We focus on lower urinary tract symptoms (LUTS), including frequent micturition, urgent urination, cough (or sneezing) leakage, dysuria, and urinary incontinence.
  • the quality of life questionnaires [ Time Frame: one year after surgery ]
    The QOL questionnaires include PFDI-20 and PFIQ-7.


Original Secondary Outcome: Same as current

Information By: Peking University People's Hospital

Dates:
Date Received: November 1, 2015
Date Started: August 2015
Date Completion: October 2020
Last Updated: May 21, 2017
Last Verified: May 2017