Pelvic Organ ProlapsePhase 3NCT02599311
the Indications and Clinical Efficacy of Pelvic Organ Prolapse Surgery
A Phase 3 study testing transvaginal synthetic mesh and Tolterodine in people with Pelvic Organ Prolapse, run by Peking University People's Hospital at 1 site in China.
Trial summary
One thousand patients with stage>2 POP are recruited. The patients are all received surgeries,such as transvaginal synthetic mesh surgery, the sacral fixation, tissue repair surgery and colpocleisis. The patients with POP who have not undergone surgery are excluded. Read more about this study
- Who is it for?
- Ages 30 to 80 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pelvic Organ Prolapse
- What is being tested?
- transvaginal synthetic mesh and Tolterodine
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,000 participants
- Where
- 1 siteChina
- Study dates
- Aug 2015to Oct 2020
- Phase
- Phase 3
- 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 30 to 80 years
- Women only
- Healthy volunteers accepted
- 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
- The patients with POP who have not undergone surgery are excluded.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Peking University People's Hospital
Beijing, Beijing Municipality, 100044
Tingting Cao, resident, 861088324354, sxlctt2015@126.com
About this study
Official title: The Clinical Efficacy of Pelvic Organ Prolapse Surgery
One thousand patients with stage>2 POP are recruited. The patients are all received surgeries,such as transvaginal synthetic mesh surgery, the sacral fixation, tissue repair surgery and colpocleisis. The patients with POP who have not undergone surgery are excluded. Postoperatively, the investigators investigate the indications and clinical efficacy of pelvic organ prolapse surgery.
Read the detailed description
Postoperatively, the investigators analyze the patients' subjective and objective recurrent rates. The investigators compare the quality of life by filling out the preoperative and postoperative scoring questionnaires (PISQ 12, PFDI-20, PFIQ-7).The electrical physiological changes will be focused on. The investigators also use Overactive Bladder Symptom Score(OABss) to assess the lower urinary tract symptoms.
- Conditions
- Pelvic Organ Prolapse
- Being tested
- transvaginal synthetic mesh, Tolterodine
- Keywords
- pelvic organ prolapse
- Medical subject headings
- Pelvic Organ Prolapse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
transvaginal synthetic meshDevice
transvaginal synthetic mesh
TolterodineDrug
Also called Tolterodine tartrate
Tolterodine tartrate can improve patients' LUTS.
| Study group | Role | What they receive |
|---|---|---|
| the efficacy | Other | transvaginal synthetic mesh Receives: Device: transvaginal synthetic mesh |
| the recurrence rate | No intervention | transvaginal synthetic mesh |
| the quality of life | No intervention | transvaginal synthetic mesh |
| the rate of the LUTS | Other | We use Tolterodine to improve patients' LUTS Receives: Drug: Tolterodine |
What is being measured
The primary outcome is the main question the study is designed to answer.
the objective recurrent rate
The objective recurrence means postoperative stage≥2 (POP-Q) in any compartment.
Measured: one year after surgery
Secondary outcomes (2)
the rate of the lower urinary tract symptoms
We focus on lower urinary tract symptoms (LUTS), including frequent micturition, urgent urination, cough (or sneezing) leakage, dysuria, and urinary incontinence.
Measured: one year after surgery
the quality of life questionnaires
The QOL questionnaires include PFDI-20 and PFIQ-7.
Measured: one year after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2015 (estimated)
- Study startAug 2015
- Primary completionOct 2019 (estimated)
- Study completionOct 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pelvic Organ ProlapseStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jianliu Wang, professor, Study chair, department of Gynecology, Peking University People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02599311
- Sponsor's protocol ID
- PKUPH
- Status last verified
- May 2017
- First submitted
- 1 Nov 2015
- Last updated
- 23 May 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Clinical Efficacy of Pelvic Organ Prolapse Surgery
- ClinicalTrials.gov ID
- NCT02599311
- Acronym / sponsor ID
- PKUPH
- Conditions
- Pelvic Organ Prolapse
- Keywords
- pelvic organ prolapse
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Peking University People's HospitalUniversity, hospital or other
- Study start
- Aug 2015
- Primary completion
- Oct 2019 (estimated)
- Study completion
- Oct 2020 (estimated)
- First posted
- 6 Nov 2015 (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.
One thousand patients with stage>2 POP are recruited. The patients are all received surgeries,such as transvaginal synthetic mesh surgery, the sacral fixation, tissue repair surgery and colpocleisis. The patients with POP who have not undergone surgery are excluded. Postoperatively, the investigators investigate the indications and clinical efficacy of pelvic organ prolapse surgery.
Detailed description
Postoperatively, the investigators analyze the patients' subjective and objective recurrent rates. The investigators compare the quality of life by filling out the preoperative and postoperative scoring questionnaires (PISQ 12, PFDI-20, PFIQ-7).The electrical physiological changes will be focused on. The investigators also use Overactive Bladder Symptom Score(OABss) to assess the lower urinary tract symptoms.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| the efficacy | Other | Device: transvaginal synthetic meshtransvaginal synthetic mesh |
| the recurrence rate | No intervention | –transvaginal synthetic mesh |
| the quality of life | No intervention | –transvaginal synthetic mesh |
| the rate of the LUTS | Other | Drug: TolterodineWe use Tolterodine to improve patients' LUTS |
Who may qualify
- Ages
- 30 to 80 years
- Sex
- Female only
- Healthy volunteers
- 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 (1 listed)
- The patients with POP who have not undergone surgery are excluded.
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 |
|---|---|---|
| transvaginal synthetic meshtransvaginal synthetic mesh | Device | the efficacy |
| TolterodineAlso: Tolterodine tartrateTolterodine tartrate can improve patients' LUTS. | Drug | the rate of the LUTS |
Primary outcome
the objective recurrent rate
Time frame: one year after surgery
The objective recurrence means postoperative stage≥2 (POP-Q) in any compartment.
2 secondary outcomes
the rate of the lower urinary tract symptoms
Time frame: one year after surgery
the quality of life questionnaires
Time frame: one year after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2017.
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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.
Jianliu Wang, professor study chair
department of Gynecology, Peking University People's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing transvaginal synthetic mesh and Tolterodine in people with Pelvic Organ Prolapse, 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 1 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 23 May 2017. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Contact Xiuli Sun, professor (861088324354, zzucaotingting@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the objective recurrent rate (time frame: one year after surgery). 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 23 May 2017.