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the Indications and Clinical Efficacy of Pelvic Organ Prolapse Surgery

Sponsor
Peking University People's Hospital (Other)
Overall Status
Unknown status
CT.gov ID
NCT02599311
Collaborator
(none)
1,000
Enrollment
1
Location
4
Arms
62
Duration (Months)
16.1
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 3

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 Design

Study Type:
Interventional
Anticipated Enrollment :
1000 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
The Clinical Efficacy of Pelvic Organ Prolapse Surgery
Study Start Date :
Aug 1, 2015
Anticipated Primary Completion Date :
Oct 1, 2019
Anticipated Study Completion Date :
Oct 1, 2020

Arms and Interventions

Arm Intervention/Treatment
Other: the efficacy

transvaginal synthetic mesh

Device: transvaginal synthetic mesh
transvaginal synthetic mesh
No Intervention: the recurrence rate

transvaginal synthetic mesh
No Intervention: the quality of life

transvaginal synthetic mesh
Other: the rate of the LUTS

We use Tolterodine to improve patients' LUTS

Drug: Tolterodine
Tolterodine tartrate can improve patients' LUTS.
Other Names:
  • Tolterodine tartrate

    		•

    Outcome Measures

    Primary Outcome Measures

    1. the objective recurrent rate [one year after surgery]

      The objective recurrence means postoperative stageā‰„2 (POP-Q) in any compartment.

    Secondary Outcome Measures

    1. 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.

    2. the quality of life questionnaires [one year after surgery]

      The QOL questionnaires include PFDI-20 and PFIQ-7.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    30 Years to 80 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    Yes
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Peking University People's Hospital Beijing Beijing China 100044

    Sponsors and Collaborators

    • Peking University People's Hospital

    Investigators

    • Study Chair: Jianliu Wang, professor, department of Gynecology, Peking University People's Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Peking University People's Hospital
    ClinicalTrials.gov Identifier:
    NCT02599311
    Other Study ID Numbers:
    • PKUPH
    First Posted:
    Nov 6, 2015
    Last Update Posted:
    May 23, 2017
    Last Verified:
    May 1, 2017
    Keywords provided by Peking University People's Hospital
    pelvic organ prolapse
    Additional relevant MeSH terms:
    Prolapse
    Pelvic Organ Prolapse
    Tolterodine Tartrate

    Study Results

    No Results Posted as of May 23, 2017