Clinical Research on Bowel Symptoms of Patient With Pelvic Organ Prolapse

Not Applicable

• Conditions: Bowel Symptoms
• Interventions: Procedure: Pelvic floor reconstruction（with or without mesh）

• Registration Number: NCT02731391
• Lead Sponsor: Peking University People's Hospital

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-01-28
• Study Start: 2016-04
• Study First Submitted QC: 2016-04-01
• Study First Posted: 2016-04-07
• Status Verified: 2021-05
• Last Update Submitted: 2021-05-26
• Last Update Posted: 2021-05-28
• Primary Completion: 2022-04
• Study Completion: 2022-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 200

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Mesh repairment	Pelvic floor reconstruction（with or without mesh）	patients undergoing pelvic floor Reconstruction using mesh
Tradition Neoplasty	Pelvic floor reconstruction（with or without mesh）	patients undergoing traditional surgical approaches

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
rectoanal inhibitory reflex recorded by anorectal manometry	baseline and 12 months after operation
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
Rectal-Vaginal pressure interval during maximum Vasalva	baseline and 6 months after operation	Measured by Peritron manometer

Trial Locations

Locations (1)

Peking University People's Hospital; 🇨🇳 Beijing, Beijing, China