Pelvic Organ ProlapsemeshNCT03070873
Anatomical and Functional Outcomes of Perigee and Apogee Mesh in Total Pelvic Floor Reconstruction Versus Gynecare Prolift
A study testing Perigee and Apogee Mesh, Gynecare Prolift Mesh and Traditional Surgery in people with Pelvic Organ Prolapse, run by Nanjing Medical University.
Trial summary
The investigators designed a prospective study in this article to evaluate the efficacy, the life quality and the complications of two different meshes of type I (one is Perigee/Apogee, the other is named Gynecare prolift) versus traditional surgery, and also studied the influence of some surgical procedures on the… Read more about this study
- Who is it for?
- Ages 50 to 85 years, women only
- Conditions the study is for
- Pelvic Organ Prolapse
- What is being tested?
- Perigee and Apogee Mesh, Gynecare Prolift Mesh and Traditional Surgery
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 258 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2010to 30 Jan 2014
- 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 50 to 85 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with stage III ~ IV degree of anterior and posterior vaginal wall prolapse and uterine prolapse (total pelvic floor prolapse) by the Pelvic Organ Prolapse Quantification System (POP-Q) were included
Who cannot join
- Simple anterior or posterior wall prolapse, simple uterine prolapse, combined with stress urinary incontinence, overactive bladder (OAB), pelvic floor repair surgery history and recurrent patients
- Local or systemic conditions that would preclude surgery or affect healing such as restricted leg motion (inability to conform to the lithotomy position)
- Vaginal bleeding;coagulation disorders
- Infection,or uncontrolled hypertension and diabetes mellitus
- Pelvic cancer and radiation to the pelvic area in the previous 6 months.
- Also women of reproductive age, and planning of pregnancy were also excluded for mesh usage.
About this study
The investigators designed a prospective study in this article to evaluate the efficacy, the life quality and the complications of two different meshes of type I (one is Perigee/Apogee, the other is named Gynecare prolift) versus traditional surgery, and also studied the influence of some surgical procedures on the prognosis.
Read the detailed description
Pelvic organ prolapse is defined as a downward descent of the pelvic organs that results in the protrusion of vagina, uterus, or both. The investigators designed a prospective study in this article to evaluate the efficacy, the life quality and the complications of two different meshes of type I (one is Perigee/Apogee, the other is named Gynecare prolift) versus traditional surgery. The investigators also studied the influence of some surgical procedures on the prognosis. In this study，The investigators divided the patients randomly into three groups :the group A was a total of 91 patients who accepted transvaginal hysterectomy and total pelvic floor reconstruction combined Perigee and Apogee polypropylene mesh(PA)；the group B was a total of 97 patients who accepted transvaginal hysterectomy and total pelvic floor reconstruction with Gynecare prolift polypropylene mesh；the group C was a total of 70 patients who accepted transvaginal hysterectomy and anterior and posterior vaginal wall repair without any mesh.The investigators did POP-Q measurements and questionnaire preoperatively and postoperatively and recorded volume of bleeding，day of postoperative indwelling catheter and the mesh complications。
- Conditions
- Pelvic Organ Prolapse
- Being tested
- Perigee and Apogee Mesh, Gynecare Prolift Mesh, Traditional Surgery
- Keywords
- Quality of life, Vaginal mesh, Mesh complications
- 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.
Perigee and Apogee MeshDevice
The investigators divided the patients randomly into three groups :the group A received Perigee and Apogee polypropylene mesh(PA)；the group B received Gynecare prolift polypropylene mesh；the group C was without any mesh.
Gynecare Prolift MeshDevice
The investigators divided the patients randomly into three groups :the group A received Perigee and Apogee polypropylene mesh(PA)；the group B received Gynecare prolift polypropylene mesh；the group C was without any mesh.
Traditional SurgeryProcedure or surgery
The investigators divided the patients randomly into three groups :the group A received Perigee and Apogee polypropylene mesh(PA)；the group B received Gynecare prolift polypropylene mesh；the group C was without any mesh.
| Study group | Role | What they receive |
|---|---|---|
| group A | Experimental | accepted Perigee and Apogee mesh(PA) Receives: Device: Perigee and Apogee Mesh |
| group B | Experimental | accepted Gynecare prolift mesh Receives: Device: Gynecare Prolift Mesh |
| group C | Placebo comparator | Traditional surgery without any mesh Receives: Procedure: Traditional Surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pelvic Organ Prolapse Quantification
the prolapse of stage II and above is defined as recurrence in POP-Q stage.
Measured: at 12 months after surgery
sexual quality of life through the pelvic organ prolapse / urinary incontinence sexual questionnaire
PISQ-12
Measured: at 12 months after surgery
pelvic floor distress inventory short form
PFDI-20
Measured: at 12 months after surgery
mesh exposure
mesh was seen in the vagina by gynecological examination
Measured: at 12 months after surgery
sexual quality of life through the pelvic organ prolapse / urinary incontinence sexual questionnaire
PISQ-12
Measured: at 24 months after surgery
Pelvic Organ Prolapse Quantification
the prolapse of stage II and above is defined as recurrence in POP-Q stage.
Measured: at 24 months after surgery
pelvic floor distress inventory short form
PFDI-20
Measured: at 24 months after surgery
mesh exposure
mesh was seen in the vagina by gynecological examination
Measured: at 24 months after surgery
sexual quality of life through the pelvic organ prolapse / urinary incontinence sexual questionnaire
PISQ-12
Measured: baseline
pelvic floor distress inventory short form
PFDI-20
Measured: baseline
Secondary outcomes (6)
stress urinary incontinence
leakage of urine with exertion or with sneezing or coughing
Measured: at 1 months after surgery
stress urinary incontinence
leakage of urine with exertion or with sneezing or coughing
Measured: 3 months after surgery
Volume of bleeding
Measured: during the operation
Elevated blood pressure
Measured: during the operation
Day of postoperative indwelling catheter
Measured: 1 months after surgery
Number of constipation
Measured: 1 months 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 Mar 2017
- Study start1 Jan 2010
- Primary completion30 Jan 2014
- Study completion30 Jan 2014
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 Nanjing Medical UniversityThe 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
- Device feasibility
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The investigators divided the patients randomly into three groups: The group A was a total of 91 patients who accepted transvaginal hysterectomy and total pelvic floor reconstruction combined Perigee and Apogee polypropylene mesh(PA)； The group B was a total of 97 patients who accepted transvaginal hysterectomy and total pelvic floor reconstruction with Gynecare prolift polypropylene mesh； The group C was a total of 70 patients who accepted transvaginal hysterectomy and anterior and posterior vaginal wall repair without any mesh.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 258 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nanjing Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xirong Guo, Nanjing Medical University
- Investigators
- Yu-Fei Shen, Study director, director of Gynecology Department , Obstetrics and Gynecology Hospital Affiliated to Nanjing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03070873
- Sponsor's protocol ID
- NMU-201666
- Acronym
- mesh
- Status last verified
- Feb 2017
- First submitted
- 15 Feb 2017
- Last updated
- 6 Mar 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anatomical and Functional Outcomes of Perigee and Apogee Mesh in Total Pelvic Floor Reconstruction Versus Gynecare Prolift
- ClinicalTrials.gov ID
- NCT03070873
- Acronym / sponsor ID
- mesh / NMU-201666
- Conditions
- Pelvic Organ Prolapse
- Keywords
- Quality of life, Vaginal mesh, Mesh complications
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 258 participants (actual)
- Lead sponsor
- Nanjing Medical UniversityUniversity, hospital or other
- Study start
- 1 Jan 2010 (actual)
- Primary completion
- 30 Jan 2014 (actual)
- Study completion
- 30 Jan 2014 (actual)
- First posted
- 6 Mar 2017 (actual)
- 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.
The investigators designed a prospective study in this article to evaluate the efficacy, the life quality and the complications of two different meshes of type I (one is Perigee/Apogee, the other is named Gynecare prolift) versus traditional surgery, and also studied the influence of some surgical procedures on the prognosis.
Detailed description
Pelvic organ prolapse is defined as a downward descent of the pelvic organs that results in the protrusion of vagina, uterus, or both. The investigators designed a prospective study in this article to evaluate the efficacy, the life quality and the complications of two different meshes of type I (one is Perigee/Apogee, the other is named Gynecare prolift) versus traditional surgery. The investigators also studied the influence of some surgical procedures on the prognosis. In this study，The investigators divided the patients randomly into three groups :the group A was a total of 91 patients who accepted transvaginal hysterectomy and total pelvic floor reconstruction combined Perigee and Apogee polypropylene mesh(PA)；the group B was a total of 97 patients who accepted transvaginal hysterectomy and total pelvic floor reconstruction with Gynecare prolift polypropylene mesh；the group C was a total of 70 patients who accepted transvaginal hysterectomy and anterior and posterior vaginal wall repair without any mesh.The investigators did POP-Q measurements and questionnaire preoperatively and postoperatively and recorded volume of bleeding，day of postoperative indwelling catheter and the mesh complications。
Study design
- Primary purpose
- Device feasibility
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
- Model description
- The investigators divided the patients randomly into three groups: The group A was a total of 91 patients who accepted transvaginal hysterectomy and total pelvic floor reconstruction combined Perigee and Apogee polypropylene mesh(PA)； The group B was a total of 97 patients who accepted transvaginal hysterectomy and total pelvic floor reconstruction with Gynecare prolift polypropylene mesh； The group C was a total of 70 patients who accepted transvaginal hysterectomy and anterior and posterior vaginal wall repair without any mesh.
| Arm | Type | Receives |
|---|---|---|
| group A | Experimental | Device: Perigee and Apogee Meshaccepted Perigee and Apogee mesh(PA) |
| group B | Experimental | Device: Gynecare Prolift Meshaccepted Gynecare prolift mesh |
| group C | Placebo comparator | Procedure: Traditional SurgeryTraditional surgery without any mesh |
Who may qualify
- Ages
- 50 to 85 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with stage III ~ IV degree of anterior and posterior vaginal wall prolapse and uterine prolapse (total pelvic floor prolapse) by the Pelvic Organ Prolapse Quantification System (POP-Q) were included
Key exclusion criteria (6 listed)
- Simple anterior or posterior wall prolapse, simple uterine prolapse, combined with stress urinary incontinence, overactive bladder (OAB), pelvic floor repair surgery history and recurrent patients
- Local or systemic conditions that would preclude surgery or affect healing such as restricted leg motion (inability to conform to the lithotomy position)
- Vaginal bleeding;coagulation disorders
- Infection,or uncontrolled hypertension and diabetes mellitus
- Pelvic cancer and radiation to the pelvic area in the previous 6 months.
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 |
|---|---|---|
| Perigee and Apogee MeshThe investigators divided the patients randomly into three groups :the group A received Perigee and Apogee polypropylene mesh(PA)；the group B received Gynecare prolift polypropylene mesh；the group C was without any mesh. | Device | group A |
| Gynecare Prolift MeshThe investigators divided the patients randomly into three groups :the group A received Perigee and Apogee polypropylene mesh(PA)；the group B received Gynecare prolift polypropylene mesh；the group C was without any mesh. | Device | group B |
| Traditional SurgeryThe investigators divided the patients randomly into three groups :the group A received Perigee and Apogee polypropylene mesh(PA)；the group B received Gynecare prolift polypropylene mesh；the group C was without any mesh. | Procedure or surgery | group C |
Primary outcome
Pelvic Organ Prolapse Quantification
Time frame: at 12 months after surgery
the prolapse of stage II and above is defined as recurrence in POP-Q stage.
sexual quality of life through the pelvic organ prolapse / urinary incontinence sexual questionnaire
Time frame: at 12 months after surgery
PISQ-12
pelvic floor distress inventory short form
Time frame: at 12 months after surgery
PFDI-20
mesh exposure
Time frame: at 12 months after surgery
mesh was seen in the vagina by gynecological examination
sexual quality of life through the pelvic organ prolapse / urinary incontinence sexual questionnaire
Time frame: at 24 months after surgery
PISQ-12
Pelvic Organ Prolapse Quantification
Time frame: at 24 months after surgery
the prolapse of stage II and above is defined as recurrence in POP-Q stage.
pelvic floor distress inventory short form
Time frame: at 24 months after surgery
PFDI-20
mesh exposure
Time frame: at 24 months after surgery
mesh was seen in the vagina by gynecological examination
sexual quality of life through the pelvic organ prolapse / urinary incontinence sexual questionnaire
Time frame: baseline
PISQ-12
pelvic floor distress inventory short form
Time frame: baseline
PFDI-20
6 secondary outcomes
stress urinary incontinence
Time frame: at 1 months after surgery
stress urinary incontinence
Time frame: 3 months after surgery
Volume of bleeding
Time frame: during the operation
Elevated blood pressure
Time frame: during the operation
Day of postoperative indwelling catheter
Time frame: 1 months after surgery
Number of constipation
Time frame: 1 months after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2017.
- Individual participant dataSharing planned: Yes
Related trials for Pelvic Organ Prolapse
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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.
Yu-Fei Shen study director
director of Gynecology Department , Obstetrics and Gynecology Hospital Affiliated to Nanjing Medical University
Questions about this trial
What is this clinical trial studying?
A study testing Perigee and Apogee Mesh, Gynecare Prolift Mesh and Traditional Surgery in people with Pelvic Organ Prolapse, run by Nanjing Medical University.
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 6 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: finished, as of the sponsor's last update on 6 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pelvic Organ Prolapse Quantification (time frame: at 12 months after surgery). The study lists 10 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 6 Mar 2017.