the Indications and Clinical Efficacy of Pelvic Organ Prolapse Surgery

Phase 3

• Conditions: Pelvic Organ Prolapse
• Interventions: Device: transvaginal synthetic mesh; Drug: Tolterodine

• Registration Number: NCT02599311
• Lead Sponsor: Peking University People's Hospital

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 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.

Study Timeline

• Study Start: 2015-08
• Study First Submitted: 2015-11-01
• Study First Submitted QC: 2015-11-05
• Study First Posted: 2015-11-06
• Status Verified: 2017-05
• Last Update Submitted: 2017-05-21
• Last Update Posted: 2017-05-23
• Primary Completion: 2019-10
• Study Completion: 2020-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 1000

Inclusion Criteria

• The patients with stage>2 POP are recruited.The patients are all received surgeries, which include transvaginal synthetic mesh surgery, the sacral fixation, tissue repair surgery and colpocleisis.

Exclusion Criteria

• The patients with POP who have not undergone surgery are excluded.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
the efficacy	transvaginal synthetic mesh	transvaginal synthetic mesh
the rate of the LUTS	Tolterodine	We use Tolterodine to improve patients' LUTS

Primary Outcome Measures

Name	Time	Method
the objective recurrent rate	one year after surgery	The objective recurrence means postoperative stage≥2 (POP-Q) in any compartment.

Secondary Outcome Measures

Name	Time	Method
the quality of life questionnaires	one year after surgery	The QOL questionnaires include PFDI-20 and PFIQ-7.
the rate of the lower urinary tract symptoms	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.

Trial Locations

Locations (1)

Peking University People's Hospital; 🇨🇳 Beijing, Beijing, China