NCT02599311

the Indications and Clinical Efficacy of Pelvic Organ Prolapse Surgery

The Clinical Efficacy of Pelvic Organ Prolapse Surgery

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,000 (estimated)
• Sponsor: Peking University People's Hospital · Academic / Other
• Sex: Female
• Age: 30 Years – 80 Years
• Healthy volunteers: Accepted

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 description

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.

Conditions

• Pelvic Organ Prolapse

Interventions

Type	Name	Description
DEVICE	transvaginal synthetic mesh	transvaginal synthetic mesh
DRUG	Tolterodine	Tolterodine tartrate can improve patients' LUTS.

Timeline

• Start date: 2015-08-01
• Primary completion: 2019-10-01
• Completion: 2020-10-01
• First posted: 2015-11-06
• Last updated: 2017-05-23

Locations

1 site across 1 country: China