the Indications and Clinical Efficacy of Pelvic Organ Pro... | NCT02599311

Studies
the Indications and Clinical Efficacy of Pelvic Organ Prolapse Surgery

NCT02599311

Sponsor

Peking University People's Hospital

Status

Unknown status

Last Update Posted

May 23, 2017Actual

Enrollment

1,000Estimated

Phase

Phase 3

Conditions

Pelvic Organ Prolapse

Interventions

transvaginal synthetic mesh
Tolterodine

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2017

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2015

Primary Completion Date

Oct 2019Estimated

Completion Date

Oct 2020Estimated

First Submitted Date

Nov 1, 2015

First Submission Date that Met QC Criteria

Nov 5, 2015

First Posted Date

Nov 6, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 21, 2017

Last Update Posted Date

May 23, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

1,000Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
the efficacy	Other	transvaginal synthetic mesh	Device: transvaginal synthetic mesh
the recurrence rate	No Intervention	transvaginal synthetic mesh
the quality of life	No Intervention	transvaginal synthetic mesh
the rate of the LUTS	Other	We use Tolterodine to improve patients' LUTS	Drug: Tolterodine

Interventions

Name	Type	Description	Arm Group Labels	Other Names
transvaginal synthetic mesh	Device	transvaginal synthetic mesh	the efficacy

Outcomes Module

Primary Outcomes

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 Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

30 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Xiuli Sun, professor	Contact	861088324354		zzucaotingting@163.com

Overall Officials

Name	Affiliation	Role
Jianliu Wang, professor	department of Gynecology, Peking University People's Hospital	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Peking University People's Hospital	Recruiting	Beijing	Beijing Municipality	100044	China

Condition Browse Module

MeSH Terms

ID	Term
D056887	Pelvic Organ Prolapse

Ancestor Terms

ID	Term
D011391	Prolapse
D020763	Pathological Conditions, Anatomical
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000068737	Tolterodine Tartrate

Ancestor Terms

ID	Term
D010665	Phenylpropanolamine
D011412	Propanolamines
D000605	Amino Alcohols
D000438	Alcohols

Browse Leaves

Not provided

Browse Branches

Not provided