Pelvic Organ ProlapseNCT04358978
A Novel Approach to Posterior Mesh Fixation in Laparoscopic Sacral Colpopexy
A study testing laparoscopic sacral colpopexy with posterior mesh no attachment and laparoscopic sacral colpopexy with posterior mesh attachment in people with Pelvic Organ Prolapse, run by Catholic University of the Sacred Heart at 1 site in Italy.
Trial summary
This randomized controlled study is designed to test the non inferiority of no attachment of posterior mesh compared to fixation of posterior mesh to the vagina in laparoscopic sacral colpopexy in terms of anatomical correction of the prolapse, post-operative and long term morbidity and rate of recurrence. Read more about this study
- Who is it for?
- Ages Up to 75 years, women only
- Conditions the study is for
- Pelvic Organ Prolapse
- What is being tested?
- laparoscopic sacral colpopexy with posterior mesh no attachment and laparoscopic sacral colpopexy with posterior mesh attachment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteItaly
- Study dates
- 23 Apr 2020to 30 Sep 2021
- 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 Up to 75 years
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- -patients who required surgical treatment for symptomatic pelvic organ prolapse stage ≥ 2 with or without stress urinary incontinence
Who cannot join
- Age > 75 years
- Severe cardiovascular or respiratory disease
- Pregnancy
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
ospedale regionale Miulli
Acquaviva delle Fonti, Bari, 70021
Maurizio Guido, PhD, 3393894243, maurizioguido@libero.it
Maurizio Guido, PhD
About this study
Official title: A Novel Approach to Posterior Mesh Fixation in Laparoscopic Sacral Colpopexy: a Randomized Control Trial
This randomized controlled study is designed to test the non inferiority of no attachment of posterior mesh compared to fixation of posterior mesh to the vagina in laparoscopic sacral colpopexy in terms of anatomical correction of the prolapse, post-operative and long term morbidity and rate of recurrence.
- Conditions
- Pelvic Organ Prolapse
- Being tested
- laparoscopic sacral colpopexy with posterior mesh no attachment, laparoscopic sacral colpopexy with posterior mesh attachment
- 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.
laparoscopic sacral colpopexy with posterior mesh no attachmentProcedure or surgery
pelvic organ prolapse correction with laparoscopic sacralcolpopexy with no attachement of posterior mesh
laparoscopic sacral colpopexy with posterior mesh attachmentProcedure or surgery
pelvic organ prolapse correction with laparoscopic sacralcolpopexy with the attachement of posterior mesh to vagina
| Study group | Role | What they receive |
|---|---|---|
| posterior mesh no attachment | Active comparator | laparoscopic sacral colpopexy with no fixation of posterior mesh Receives: Procedure: laparoscopic sacral colpopexy with posterior mesh no attachment |
| posterior mesh attachment | Active comparator | laparoscopic sacral colpopexy with fixation of posterior mesh by suture Receives: Procedure: laparoscopic sacral colpopexy with posterior mesh attachment |
What is being measured
The primary outcome is the main question the study is designed to answer.
correction of pelvic organ prolapse
number of women with correction of prolapse mesured in S POP-Q stage during FU visit
Measured: 1 year
Secondary outcomes (2)
rate of recurrence
number of women with de novo anterior or posterior or central prolapse
Measured: 1 year
long term outcomes
number of women with nicturia, dysuria, obstructed defecation , urinary incontinence, pelvic pain
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2020
- Study start23 Apr 2020
- Primary completion30 Sep 2021 (estimated)
- Study completion30 Sep 2021 (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.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Catholic University of the Sacred Heart
- Sponsor type
- University, hospital or other
- Collaborators
- Miulli General Hospital
- Responsible party
- Principal investigator, Maurizio Guido, Catholic University of the Sacred Heart
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04358978
- Sponsor's protocol ID
- Ospedale "F. Miulli"
- Status last verified
- Jul 2020
- First submitted
- 21 Apr 2020
- Last updated
- 24 Jul 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Novel Approach to Posterior Mesh Fixation in Laparoscopic Sacral Colpopexy: a Randomized Control Trial
- ClinicalTrials.gov ID
- NCT04358978
- Acronym / sponsor ID
- Ospedale "F. Miulli"
- Conditions
- Pelvic Organ Prolapse
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Catholic University of the Sacred HeartUniversity, hospital or other
- Collaborators
- Miulli General Hospital
- Study start
- 23 Apr 2020 (actual)
- Primary completion
- 30 Sep 2021 (estimated)
- Study completion
- 30 Sep 2021 (estimated)
- First posted
- 24 Apr 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 randomized controlled study is designed to test the non inferiority of no attachment of posterior mesh compared to fixation of posterior mesh to the vagina in laparoscopic sacral colpopexy in terms of anatomical correction of the prolapse, post-operative and long term morbidity and rate of recurrence.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| posterior mesh no attachment | Active comparator | Procedure: laparoscopic sacral colpopexy with posterior mesh no attachmentlaparoscopic sacral colpopexy with no fixation of posterior mesh |
| posterior mesh attachment | Active comparator | Procedure: laparoscopic sacral colpopexy with posterior mesh attachmentlaparoscopic sacral colpopexy with fixation of posterior mesh by suture |
Who may qualify
- Ages
- Up to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- -patients who required surgical treatment for symptomatic pelvic organ prolapse stage ≥ 2 with or without stress urinary incontinence
Key exclusion criteria (3 listed)
- Age > 75 years
- Severe cardiovascular or respiratory disease
- Pregnancy
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 |
|---|---|---|
| laparoscopic sacral colpopexy with posterior mesh no attachmentpelvic organ prolapse correction with laparoscopic sacralcolpopexy with no attachement of posterior mesh | Procedure or surgery | posterior mesh no attachment |
| laparoscopic sacral colpopexy with posterior mesh attachmentpelvic organ prolapse correction with laparoscopic sacralcolpopexy with the attachement of posterior mesh to vagina | Procedure or surgery | posterior mesh attachment |
Primary outcome
correction of pelvic organ prolapse
Time frame: 1 year
number of women with correction of prolapse mesured in S POP-Q stage during FU visit
2 secondary outcomes
rate of recurrence
Time frame: 1 year
long term outcomes
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing laparoscopic sacral colpopexy with posterior mesh no attachment and laparoscopic sacral colpopexy with posterior mesh attachment in people with Pelvic Organ Prolapse, run by Catholic University of the Sacred Heart at 1 site in Italy.
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 3 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 24 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 Italy. 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?
Contact Maurizio Guido (3393894243, maurizioguido@libero.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
correction of pelvic organ prolapse (time frame: 1 year). 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 24 Jul 2020.