Clinical Research on Bowel Symptoms of Patient With Pelvic Organ Prolapse

Bowel Symptoms Clinical Trial

Official title:

Clinical Research on Bowel Symptoms of Patients With Pelvic Organ Prolapse

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02731391
• Other study ID #: pkuph-0103969
• Status: Recruiting
• Phase: N/A
• 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
• 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.

Related Conditions & MeSH terms

• Bowel Symptoms
• Pelvic Organ Prolapse
• Prolapse

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