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
  • Procedure: Pelvic floor reconstruction(with or without mesh)
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

  1. change in the prevalence of bowel symptoms [baseline,1,3,6,12 months after operation.]

  2. 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

  1. change in the quality of life [baseline,1,3,6,12 months after operation.]

    assessed by international consultation on incontinence questionnaire short form

  2. length of the high-pressure zone recorded by anorectal manometry [baseline and 12 months after operation]

  3. rectoanal inhibitory reflex recorded by anorectal manometry [baseline and 12 months after operation]

  4. 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
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 28, 2021