Clinical Research on Bowel Symptoms of Patient With Pelvic Organ Prolapse

Clinical Research on Bowel Symptoms of Patients With Pelvic Organ Prolapse

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

Study Overview

• Status: Recruiting
• Conditions: Bowel Symptoms
• Intervention / Treatment: Procedure: Pelvic floor reconstruction（with or without mesh）

• Study Type: Interventional
• Enrollment (Anticipated): 200
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100044
      • Recruiting
      • Peking University People's Hospital
      • Contact: Shan Wang, doctor; Email: iao@pkuph.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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）

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
change in the prevalence of bowel symptoms		baseline,1,3,6,12 months after operation.
change in the severity of intestinal symptoms	assessed by Birmingham Bowel and Urinary Symptoms Questionnaire	baseline,1,3,6,12 months after operation.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
change in the quality of life	assessed by international consultation on incontinence questionnaire short form	baseline,1,3,6,12 months after operation.
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	Measured by Peritron manometer	baseline and 6 months after operation

Collaborators and Investigators

• Sponsor: Peking University People's Hospital

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2016
• Primary Completion (Anticipated): April 1, 2022
• Study Completion (Anticipated): May 1, 2022

Study Registration Dates

• First Submitted: January 28, 2016
• First Submitted That Met QC Criteria: April 1, 2016
• First Posted (Estimate): April 7, 2016

Study Record Updates

• Last Update Posted (Actual): May 28, 2021
• Last Update Submitted That Met QC Criteria: May 26, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Prolapse; Pelvic Organ Prolapse
• Other Study ID Numbers: pkuph-0103969

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No