Clinical Research on Bowel Symptoms of Patient With Pelvic Organ Prolapse
Sponsor
Peking University People's Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT02731391
Collaborator
(none)
200
1
2
73
2.7
Study Details
Study Description
Brief Summary
To study the prevalence of bowel symptoms in patients with pelvic organ prolapse.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
N/A |
Study Design
Study Type:
Interventional
Anticipated Enrollment
:
200 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Clinical Research on Bowel Symptoms of Patients With Pelvic Organ Prolapse
Actual Study Start Date
:
Apr 1, 2016
Anticipated Primary Completion Date
:
Apr 1, 2022
Anticipated Study Completion Date
:
May 1, 2022
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: Mesh repairment patients undergoing pelvic floor Reconstruction using mesh |
Procedure: Pelvic floor reconstruction(with or without mesh)
|
Active Comparator: Tradition Neoplasty patients undergoing traditional surgical approaches |
Procedure: Pelvic floor reconstruction(with or without mesh)
|
Outcome Measures
Primary Outcome Measures
- change in the prevalence of bowel symptoms [baseline,1,3,6,12 months after operation.]
- change in the severity of intestinal symptoms [baseline,1,3,6,12 months after operation.]
assessed by Birmingham Bowel and Urinary Symptoms Questionnaire
Secondary Outcome Measures
- change in the quality of life [baseline,1,3,6,12 months after operation.]
assessed by international consultation on incontinence questionnaire short form
- length of the high-pressure zone recorded by anorectal manometry [baseline and 12 months after operation]
- rectoanal inhibitory reflex recorded by anorectal manometry [baseline and 12 months after operation]
- Rectal-Vaginal pressure interval during maximum Vasalva [baseline and 6 months after operation]
Measured by Peritron manometer
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
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.
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
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Tan Cheng,
doctor,
Peking University People's Hospital
ClinicalTrials.gov Identifier:
NCT02731391
Other Study ID Numbers:
- pkuph-0103969
First Posted:
Apr 7, 2016
Last Update Posted:
May 28, 2021
Last Verified:
May 1, 2021