the Indications and Clinical Efficacy of Pelvic Organ Prolapse Surgery

Peking University

Status and phase: Unknown; Phase 3

Conditions: Pelvic Organ Prolapse

Treatments: Drug: Tolterodine; Device: transvaginal synthetic mesh

Study type: Interventional

Funder types: Other

Identifiers

NCT02599311

PKUPH

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,000 estimated patients

Sex: Female

Ages: 30 to 80 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,000 participants in 4 patient groups

the efficacy

Other group

Description:

transvaginal synthetic mesh

Treatment:

Device: transvaginal synthetic mesh

the recurrence rate

No Intervention group

Description:

transvaginal synthetic mesh

the quality of life

No Intervention group

Description:

transvaginal synthetic mesh

the rate of the LUTS

Other group

Description:

We use Tolterodine to improve patients' LUTS

Treatment:

Drug: Tolterodine