the Indications and Clinical Efficacy of Pelvic Organ Prolapse Surgery

Study Overview
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Brief Summary
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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
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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.

Official Title
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The Clinical Efficacy of Pelvic Organ Prolapse Surgery

Conditions
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Pelvic Organ Prolapse

Intervention / Treatment
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* Device: transvaginal synthetic mesh
* Drug: Tolterodine


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: the efficacy<br>transvaginal synthetic mesh | Device: transvaginal synthetic mesh<br>* transvaginal synthetic mesh<br>|
| No Intervention: the recurrence rate<br>transvaginal synthetic mesh | |
| No Intervention: the quality of life<br>transvaginal synthetic mesh | |
| Other: the rate of the LUTS<br>We use Tolterodine to improve patients' LUTS | Drug: Tolterodine<br>* Tolterodine tartrate can improve patients' LUTS.<br>* Other names: Tolterodine tartrate;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the objective recurrent rate | The objective recurrence means postoperative stage≥2 (POP-Q) in any compartment. | one year after surgery | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pelvic organ prolapse