Bowel SymptomsNCT02731391
Clinical Research on Bowel Symptoms of Patient With Pelvic Organ Prolapse
A study testing Pelvic floor reconstruction（with or without mesh） in people with Bowel Symptoms, run by Peking University People's Hospital at 1 site in China.
Trial summary
To study the prevalence of bowel symptoms in patients with pelvic organ prolapse. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Bowel Symptoms
- What is being tested?
- Pelvic floor reconstruction（with or without mesh）
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- Apr 2016to May 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Gestation；
- Inflammatory bowel disease；
- Slow transit constipation diagnosed by Colonic transit test；
- Unable to follow up.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Peking University People's Hospital
Beijing, Beijing Municipality, 100044
Shan Wang, doctor, iao@pkuph.edu.cn
About this study
Official title: Clinical Research on Bowel Symptoms of Patients With Pelvic Organ Prolapse
To study the prevalence of bowel symptoms in patients with pelvic organ prolapse.
- Conditions
- Bowel Symptoms
- Being tested
- Pelvic floor reconstruction（with or without mesh）
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pelvic floor reconstruction（with or without mesh）Procedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Mesh repairment | Experimental | patients undergoing pelvic floor Reconstruction using mesh Receives: Procedure: Pelvic floor reconstruction（with or without mesh） |
| Tradition Neoplasty | Active comparator | patients undergoing traditional surgical approaches Receives: Procedure: Pelvic floor reconstruction（with or without mesh） |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in the prevalence of bowel symptoms
Measured: baseline,1,3,6,12 months after operation.
change in the severity of intestinal symptoms
assessed by Birmingham Bowel and Urinary Symptoms Questionnaire
Measured: baseline,1,3,6,12 months after operation.
Secondary outcomes (4)
change in the quality of life
assessed by international consultation on incontinence questionnaire short form
Measured: baseline,1,3,6,12 months after operation.
length of the high-pressure zone recorded by anorectal manometry
Measured: baseline and 12 months after operation
rectoanal inhibitory reflex recorded by anorectal manometry
Measured: baseline and 12 months after operation
Rectal-Vaginal pressure interval during maximum Vasalva
Measured by Peritron manometer
Measured: baseline and 6 months after operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2016 (estimated)
- Study startApr 2016
- Primary completionApr 2022 (estimated)
- Study completionMay 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bowel SymptomsStudies of the same condition, open and under way.
- More trials run by Peking University People's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tan Cheng, Peking University People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02731391
- Sponsor's protocol ID
- pkuph-0103969
- Status last verified
- May 2021
- First submitted
- 28 Jan 2016
- Last updated
- 28 May 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Research on Bowel Symptoms of Patients With Pelvic Organ Prolapse
- ClinicalTrials.gov ID
- NCT02731391
- Acronym / sponsor ID
- pkuph-0103969
- Conditions
- Bowel Symptoms
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Peking University People's HospitalUniversity, hospital or other
- Study start
- Apr 2016 (actual)
- Primary completion
- Apr 2022 (estimated)
- Study completion
- May 2022 (estimated)
- First posted
- 7 Apr 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To study the prevalence of bowel symptoms in patients with pelvic organ prolapse.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mesh repairment | Experimental | Procedure: Pelvic floor reconstruction（with or without mesh）patients undergoing pelvic floor Reconstruction using mesh |
| Tradition Neoplasty | Active comparator | Procedure: Pelvic floor reconstruction（with or without mesh）patients undergoing traditional surgical approaches |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (4 listed)
- Gestation；
- Inflammatory bowel disease；
- Slow transit constipation diagnosed by Colonic transit test；
- Unable to follow up.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pelvic floor reconstruction（with or without mesh） | Procedure or surgery | Mesh repairment, Tradition Neoplasty |
Primary outcome
change in the prevalence of bowel symptoms
Time frame: baseline,1,3,6,12 months after operation.
change in the severity of intestinal symptoms
Time frame: baseline,1,3,6,12 months after operation.
assessed by Birmingham Bowel and Urinary Symptoms Questionnaire
4 secondary outcomes
change in the quality of life
Time frame: baseline,1,3,6,12 months after operation.
length of the high-pressure zone recorded by anorectal manometry
Time frame: baseline and 12 months after operation
rectoanal inhibitory reflex recorded by anorectal manometry
Time frame: baseline and 12 months after operation
Rectal-Vaginal pressure interval during maximum Vasalva
Time frame: baseline and 6 months after operation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pelvic floor reconstruction（with or without mesh） in people with Bowel Symptoms, run by Peking University People's Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change in the prevalence of bowel symptoms (time frame: baseline,1,3,6,12 months after operation.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2021; AzTrials last refreshed its copy on 8 Nov 2026.