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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02731391
Other study ID # pkuph-0103969
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date April 2016
Est. completion date May 2022

Study information

Verified date May 2021
Source Peking University People's Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


Recruitment information / eligibility

Status Recruiting
Enrollment 200
Est. completion date May 2022
Est. primary completion date April 2022
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Pelvic floor reconstruction(with or without mesh)


Locations

Country Name City State
China Peking University People's Hospital Beijing Beijing

Sponsors (1)

Lead Sponsor Collaborator
Peking University People's Hospital

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary change in the prevalence of bowel symptoms baseline,1,3,6,12 months after operation.
Primary change in the severity of intestinal symptoms assessed by Birmingham Bowel and Urinary Symptoms Questionnaire baseline,1,3,6,12 months after operation.
Secondary change in the quality of life assessed by international consultation on incontinence questionnaire short form baseline,1,3,6,12 months after operation.
Secondary length of the high-pressure zone recorded by anorectal manometry baseline and 12 months after operation
Secondary rectoanal inhibitory reflex recorded by anorectal manometry baseline and 12 months after operation
Secondary Rectal-Vaginal pressure interval during maximum Vasalva Measured by Peritron manometer baseline and 6 months after operation
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