CystoceleNCT04481906
Vaginal Mesh Procedures for Female Cystocele
An observational study of Cystocele, run by Cathay General Hospital at 1 site in Taiwan.
Trial summary
This study aimed to evaluate primarily the functional outcomes and secondly the morphological outcomes for women who had received standard managements for cystocele at mediate-term follow-up. Read more about this study
- Who is it for?
- Ages 240 months and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cystocele
- What is being tested?
- Vaginal mesh for female cystocele
- Type of treatment
- Surgery or procedure
- How many people
- 160 participants
- Where
- 1 siteTaiwan
- Study dates
- 25 Oct 2011to 5 Oct 2014
- Phase
- Observational
- 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 240 months and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Women 20 years or older with cystocele
Who may be able to join
- Clinical diagnosis of cystocele
Who cannot join
- Pregnancy or possibility of future pregnancy
- Urinary tract infection
- Diabetes
- Neurological diseases
- Cardiovascular diseases
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Long-term Follow-up of Vaginal Mesh Procedures for Female Cystocele
This study aimed to evaluate primarily the functional outcomes and secondly the morphological outcomes for women who had received standard managements for cystocele at mediate-term follow-up.
Read the detailed description
Pelvic organ prolapsed (POP) is an important health issue for women all over the world, with cystocele being the commonest type of POP. The side effects related to cystocele include voiding dysfunction, urinary retention, urinary tract infection, hydroureter, or hydronephrosis. The management for cystocele can be classified as non-surgical and surgical methods. Non-surgical methods comprise pelvic floor muscle exercise and vaginal pessaries, while surgical methods can be divided as conventional operations and operations applying mesh augmentation. Conventional surgeries for cystocele such as anterior colporrhapy have high surgical failure rates and complications including vaginal shortening or vaginal stenosis. Operations applying mesh augmentation are becoming the mainstream in the surgeries for cystocle. The Perigee System (American Medical Systems, Minnetonka, MN, USA), which has been approved by American FDA and Taiwan DOH in treating female cystocele, have promising short-term surgical outcomes. However, long-term reports incorporating both functional and morphological outcomes are lacking in the literatures. This study aimed to evaluate primarily the functional outcomes and secondly the morphological outcomes for women who had received standard managements for cystocele at mediate-term follow-up.
- Conditions
- Cystocele
- Being tested
- Vaginal mesh for female cystocele
- Keywords
- cystocele, pelvic floor muscle exercise, anterior vaginal repair, vaginal mesh
- Medical subject headings
- Cystocele
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vaginal mesh for female cystoceleProcedure or surgery
Vaginal mesh procedures (e.g. Perigee) were susgested for women with POP-Q stage III or more cystocele
| Study group | Role | What they receive |
|---|---|---|
| Women 20 years and older with cystocele | Women 20 years and older with cystocele Receives: Procedure: Vaginal mesh for female cystocele |
What is being measured
The primary outcome is the main question the study is designed to answer.
POP-Q Ba point
POP-Q Ba > II POP-Q stage
Measured: Preoperative, as well as postoperative 3 months, 12 months, and then anuuanlly
Secondary outcomes (1)
Functional and ultrasound manifestations
Urinary incontinence, overactive bladder symptoms, voiding dysfunction, bladder neck position on ultrasound
Measured: Preoperative, as well as postoperative 3 months, 12 months, and then anuuanlly
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2020
- Study start25 Oct 2011
- Primary completion16 Jun 2012
- Study completion5 Oct 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CystoceleStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cathay General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04481906
- Sponsor's protocol ID
- CGH-P100072
- Status last verified
- Jul 2018
- First submitted
- 16 Jul 2018
- Last updated
- 22 Jul 2020
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-term Follow-up of Vaginal Mesh Procedures for Female Cystocele
- ClinicalTrials.gov ID
- NCT04481906
- Acronym / sponsor ID
- CGH-P100072
- Conditions
- Cystocele
- Keywords
- cystocele, pelvic floor muscle exercise, anterior vaginal repair, vaginal mesh
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- Cathay General HospitalUniversity, hospital or other
- Study start
- 25 Oct 2011
- Primary completion
- 16 Jun 2012 (actual)
- Study completion
- 5 Oct 2014 (actual)
- First posted
- 22 Jul 2020 (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.
This study aimed to evaluate primarily the functional outcomes and secondly the morphological outcomes for women who had received standard managements for cystocele at mediate-term follow-up.
Detailed description
Pelvic organ prolapsed (POP) is an important health issue for women all over the world, with cystocele being the commonest type of POP. The side effects related to cystocele include voiding dysfunction, urinary retention, urinary tract infection, hydroureter, or hydronephrosis. The management for cystocele can be classified as non-surgical and surgical methods. Non-surgical methods comprise pelvic floor muscle exercise and vaginal pessaries, while surgical methods can be divided as conventional operations and operations applying mesh augmentation. Conventional surgeries for cystocele such as anterior colporrhapy have high surgical failure rates and complications including vaginal shortening or vaginal stenosis. Operations applying mesh augmentation are becoming the mainstream in the surgeries for cystocle. The Perigee System (American Medical Systems, Minnetonka, MN, USA), which has been approved by American FDA and Taiwan DOH in treating female cystocele, have promising short-term surgical outcomes. However, long-term reports incorporating both functional and morphological outcomes are lacking in the literatures. This study aimed to evaluate primarily the functional outcomes and secondly the morphological outcomes for women who had received standard managements for cystocele at mediate-term follow-up.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Women 20 years and older with cystocele | – | Procedure: Vaginal mesh for female cystoceleWomen 20 years and older with cystocele |
Who may qualify
- Ages
- 240 months and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Women 20 years or older with cystocele
Key inclusion criteria (1 listed)
- Clinical diagnosis of cystocele
Key exclusion criteria (5 listed)
- Pregnancy or possibility of future pregnancy
- Urinary tract infection
- Diabetes
- Neurological diseases
- Cardiovascular diseases
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 |
|---|---|---|
| Vaginal mesh for female cystoceleVaginal mesh procedures (e.g. Perigee) were susgested for women with POP-Q stage III or more cystocele | Procedure or surgery | Women 20 years and older with cystocele |
Primary outcome
POP-Q Ba point
Time frame: Preoperative, as well as postoperative 3 months, 12 months, and then anuuanlly
POP-Q Ba > II POP-Q stage
1 secondary outcome
Functional and ultrasound manifestations
Time frame: Preoperative, as well as postoperative 3 months, 12 months, and then anuuanlly
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 22 Jul 2020.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cystocele, run by Cathay General Hospital at 1 site in Taiwan.
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 5 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 22 Jul 2020. 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 Taiwan. 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?
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?
POP-Q Ba point (time frame: Preoperative, as well as postoperative 3 months, 12 months, and then anuuanlly). 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 22 Jul 2020.