the Indications and Clinical Efficacy of Pelvic Organ Prolapse Surgery

NCT ID: NCT02599311

Last Updated: 2017-05-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

1000 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-08-31

Study Completion Date

2020-10-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Pelvic Organ Prolapse

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

the efficacy

transvaginal synthetic mesh

Group Type OTHER

transvaginal synthetic mesh

Intervention Type DEVICE

transvaginal synthetic mesh

the recurrence rate

transvaginal synthetic mesh

Group Type NO_INTERVENTION

No interventions assigned to this group

the quality of life

transvaginal synthetic mesh

Group Type NO_INTERVENTION

No interventions assigned to this group

the rate of the LUTS

We use Tolterodine to improve patients' LUTS

Group Type OTHER

Tolterodine

Intervention Type DRUG

Tolterodine tartrate can improve patients' LUTS.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

transvaginal synthetic mesh

transvaginal synthetic mesh

Intervention Type DEVICE

Tolterodine

Tolterodine tartrate can improve patients' LUTS.

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Tolterodine tartrate

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

30 Years

Maximum Eligible Age

80 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Peking University People's Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Jianliu Wang, professor

Role: STUDY_CHAIR

department of Gynecology, Peking University People's Hospital

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Peking University People's Hospital

Beijing, Beijing Municipality, China

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

China

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Xiuli Sun, professor

Role: CONTACT

861088324354

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Tingting Cao, resident

Role: primary

861088324354

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

PKUPH

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.