Prolapse of the UterusPROMONOTECHONCT03634878
Evaluation of the Position of Promontofixation Prostheses in Perineal Ultrasound
A study testing perineal ultrasound in people with Prolapse of the Uterus, run by Poitiers University Hospital at 1 site in France.
Trial summary
Indirect promontofixation with prostheses is the standard surgical technique for the reference of uterine prolapse. There is no validated examination to control the position of the prostheses postoperatively. These prostheses are echogenic and perineal ultrasound could be a means of postoperative monitoring. Read more about this study
- Who is it for?
- Ages 18 to 100 years, women only
- Conditions the study is for
- Prolapse of the Uterus
- What is being tested?
- perineal ultrasound
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- Apr 2016to Oct 2018
- 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 to 100 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years of female sex
- Patient with double laparoscopic promontofixation without associated hysterectomy
Who cannot join
- History of hysterectomy
- Anterior cure (before index intervention) of prolapse with placement of prosthetic material.
Trial locations and contacts
1 site in 1 country.
About this study
Indirect promontofixation with prostheses is the standard surgical technique for the reference of uterine prolapse. There is no validated examination to control the position of the prostheses postoperatively.
These prostheses are echogenic and perineal ultrasound could be a means of postoperative monitoring. There is no data in the literature on the relationship between prosthesis position and postoperative symptoms
- Conditions
- Prolapse of the Uterus
- Being tested
- perineal ultrasound
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
perineal ultrasoundOther
Ultrasound measurement of the size and position of the prostheses.
| Study group | Role | What they receive |
|---|---|---|
| Perineal ultrasound to visualize the strips and their position | Experimental | Not described Receives: Other: perineal ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the reproducibility study of intra and interobserver measurements of the size of promontofixation prostheses
Measured: 10 minutes
Evaluate the reproducibility study of intra and interobserver measurements position of promontofixation prostheses
Measured: 20 minutes
Secondary outcomes (2)
Collect the position of the strips
Measured: 20 minutes
Collect the symptoms of the patients
Measured: 20 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2018
- Study startApr 2016
- Primary completionOct 2018
- Study completionOct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prolapse of the UterusStudies of the same condition, open and under way.
- More trials run by Poitiers University 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Poitiers University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Xaviar FRITEL, Principal investigator, Poitiers University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03634878
- Sponsor's protocol ID
- PROMONTECHO
- Acronym
- PROMONOTECHO
- Status last verified
- Apr 2020
- First submitted
- 6 Aug 2018
- Last updated
- 13 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Position of Promontofixation Prostheses in Perineal Ultrasound
- ClinicalTrials.gov ID
- NCT03634878
- Acronym / sponsor ID
- PROMONOTECHO / PROMONTECHO
- Conditions
- Prolapse of the Uterus
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Poitiers University HospitalUniversity, hospital or other
- Study start
- Apr 2016 (actual)
- Primary completion
- Oct 2018 (actual)
- Study completion
- Oct 2018 (actual)
- First posted
- 17 Aug 2018 (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.
Indirect promontofixation with prostheses is the standard surgical technique for the reference of uterine prolapse. There is no validated examination to control the position of the prostheses postoperatively.
These prostheses are echogenic and perineal ultrasound could be a means of postoperative monitoring. There is no data in the literature on the relationship between prosthesis position and postoperative symptoms
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Perineal ultrasound to visualize the strips and their position | Experimental | Other: perineal ultrasound |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age ≥ 18 years of female sex
- Patient with double laparoscopic promontofixation without associated hysterectomy
Key exclusion criteria (2 listed)
- History of hysterectomy
- Anterior cure (before index intervention) of prolapse with placement of prosthetic material.
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 |
|---|---|---|
| perineal ultrasoundUltrasound measurement of the size and position of the prostheses. | Other | Perineal ultrasound to visualize the strips and their position |
Primary outcome
Evaluate the reproducibility study of intra and interobserver measurements of the size of promontofixation prostheses
Time frame: 10 minutes
Evaluate the reproducibility study of intra and interobserver measurements position of promontofixation prostheses
Time frame: 20 minutes
2 secondary outcomes
Collect the position of the strips
Time frame: 20 minutes
Collect the symptoms of the patients
Time frame: 20 minutes
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 13 Apr 2020.
- Individual participant dataSharing planned: No
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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.
Xaviar FRITEL principal investigator
Poitiers University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing perineal ultrasound in people with Prolapse of the Uterus, run by Poitiers University Hospital at 1 site in France.
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 2 inclusion and 2 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 13 Apr 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 France. 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?
Evaluate the reproducibility study of intra and interobserver measurements of the size of promontofixation prostheses (time frame: 10 minutes). 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 13 Apr 2020.