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Clinical Research on Bowel Symptoms of Patient With Pelvic Organ Prolapse

Primary Purpose

Bowel Symptoms

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Pelvic floor reconstruction（with or without mesh）
Sponsored by
Peking University People's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bowel Symptoms

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept 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:

  • Gestation；
  • Inflammatory bowel disease；
  • Slow transit constipation diagnosed by Colonic transit test；
  • Unable to follow up.

Sites / Locations

  • Peking University People's HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Mesh repairment

Tradition Neoplasty

Arm Description

patients undergoing pelvic floor Reconstruction using mesh

patients undergoing traditional surgical approaches

Outcomes

Primary Outcome Measures

change in the prevalence of bowel symptoms
change in the severity of intestinal symptoms
assessed by Birmingham Bowel and Urinary Symptoms Questionnaire

Secondary Outcome Measures

change in the quality of life
assessed by international consultation on incontinence questionnaire short form
length of the high-pressure zone recorded by anorectal manometry
rectoanal inhibitory reflex recorded by anorectal manometry
Rectal-Vaginal pressure interval during maximum Vasalva
Measured by Peritron manometer

Full Information

First Posted
January 28, 2016
Last Updated
May 26, 2021
Sponsor
Peking University People's Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02731391
Brief Title
Clinical Research on Bowel Symptoms of Patient With Pelvic Organ Prolapse
Official Title
Clinical Research on Bowel Symptoms of Patients With Pelvic Organ Prolapse
Study Type
Interventional

2. Study Status

Record Verification Date
May 2021
Overall Recruitment Status
Unknown status
Study Start Date
April 2016 (Actual)
Primary Completion Date
April 2022 (Anticipated)
Study Completion Date
May 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Peking University People's Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
To study the prevalence of bowel symptoms in patients with pelvic organ prolapse.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bowel Symptoms

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Mesh repairment
Arm Type
Experimental
Arm Description
patients undergoing pelvic floor Reconstruction using mesh
Arm Title
Tradition Neoplasty
Arm Type
Active Comparator
Arm Description
patients undergoing traditional surgical approaches
Intervention Type
Procedure
Intervention Name(s)
Pelvic floor reconstruction（with or without mesh）
Primary Outcome Measure Information:
Title
change in the prevalence of bowel symptoms
Time Frame
baseline,1,3,6,12 months after operation.
Title
change in the severity of intestinal symptoms
Description
assessed by Birmingham Bowel and Urinary Symptoms Questionnaire
Time Frame
baseline,1,3,6,12 months after operation.
Secondary Outcome Measure Information:
Title
change in the quality of life
Description
assessed by international consultation on incontinence questionnaire short form
Time Frame
baseline,1,3,6,12 months after operation.
Title
length of the high-pressure zone recorded by anorectal manometry
Time Frame
baseline and 12 months after operation
Title
rectoanal inhibitory reflex recorded by anorectal manometry
Time Frame
baseline and 12 months after operation
Title
Rectal-Vaginal pressure interval during maximum Vasalva
Description
Measured by Peritron manometer
Time Frame
baseline and 6 months after operation

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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: Gestation； Inflammatory bowel disease； Slow transit constipation diagnosed by Colonic transit test； Unable to follow up.
Facility Information:
Facility Name
Peking University People's Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100044
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shan Wang, doctor
Email
iao@pkuph.edu.cn

12. IPD Sharing Statement

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Clinical Research on Bowel Symptoms of Patient With Pelvic Organ Prolapse

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