Genital ProlapseRICHTERNCT03901586
Satisfaction and Long-term Anatomic Efficacy Study on Patients Who Underwent a Richter Intervention in the Obstetric and Gynecology Department of Foch Hospital Since 2008
A study testing Satisfaction assessment, Quality of life and Gynecological assessment in people with Genital Prolapse, run by Hopital Foch at 1 site in France.
Trial summary
Satisfaction and Long-term Anatomic Efficacy will be assessed on Patients Who Underwent a Richter Intervention in the Obstetric and Gynecology Department of Foch Hospital Since 2008. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Genital Prolapse
- What is being tested?
- Satisfaction assessment, Quality of life and Gynecological assessment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- 1 siteFrance
- Study dates
- 1 Dec 2018to 30 Apr 2019
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient who underwent a Richter intervention between 01/01/2008 and 31/12/2017 in the Gynecology Department of Foch Hospital
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
Satisfaction and Long-term Anatomic Efficacy will be assessed on Patients Who Underwent a Richter Intervention in the Obstetric and Gynecology Department of Foch Hospital Since 2008.
Read the detailed description
Satisfaction and Long-term Anatomic Efficacy will be assessed on Patients Who Underwent a Richter Intervention in the Obstetric and Gynecology Department of Foch Hospital Since 2008.
- Conditions
- Genital Prolapse
- Being tested
- Satisfaction assessment, Quality of life, Gynecological assessment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Satisfaction assessmentOther
Patient will be asked to assess their satisfaction concerning the Richter procedure and its long term effect
Quality of lifeOther
The Quality of life will be assessed with 3 questionnaires (I-Qol / PISQ-12/PFDI-20)
Gynecological assessmentOther
An optional gynecological consult is proposed to the patients to better estimate the gynecological long-term impact of the procedure
| Study group | Role | What they receive |
|---|---|---|
| Patients who had Richter intervention | Experimental | Not described Receives: Other: Satisfaction assessment; Other: Quality of life; Other: Gynecological assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Long-term satisfaction of the Richter procedure
It will be ask to the patients to evaluate their satisfaction of the procedure, base on a 4-answer scale ("Not at all satisfied", "Not very satisfied", "Moderately satisfied", "Fully satisfied")
Measured: 4 months
Secondary outcomes (2)
Long term anatomic impact of the procedure
An optional gynecological consult is proposed to the patients
Measured: 7 months
Post-operative complications
Post-operative complications will be collected and compared to the anatomic impact of the procedure and the patient satisfaction
Measured: 7 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2019
- Study start1 Dec 2018
- Primary completion30 Apr 2019
- Study completion30 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Genital 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hopital Foch
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Angeline Favre-Inhofer, Principal investigator, Hôpital FochJean-Marc Ayoubi, Study director, Hôpital Foch
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03901586
- Sponsor's protocol ID
- 2018_0072
- Acronym
- RICHTER
- Status last verified
- Nov 2018
- First submitted
- 2 Apr 2019
- Last updated
- 16 May 2019
- 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 16 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Satisfaction and Long-term Anatomic Efficacy Study on Patients Who Underwent a Richter Intervention in the Obstetric and Gynecology Department of Foch Hospital Since 2008
- ClinicalTrials.gov ID
- NCT03901586
- Acronym / sponsor ID
- RICHTER / 2018_0072
- Conditions
- Genital Prolapse
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- Hopital FochUniversity, hospital or other
- Study start
- 1 Dec 2018 (actual)
- Primary completion
- 30 Apr 2019 (actual)
- Study completion
- 30 Apr 2019 (actual)
- First posted
- 3 Apr 2019 (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.
Satisfaction and Long-term Anatomic Efficacy will be assessed on Patients Who Underwent a Richter Intervention in the Obstetric and Gynecology Department of Foch Hospital Since 2008.
Detailed description
Satisfaction and Long-term Anatomic Efficacy will be assessed on Patients Who Underwent a Richter Intervention in the Obstetric and Gynecology Department of Foch Hospital Since 2008.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients who had Richter intervention | Experimental | Other: Satisfaction assessment, Other: Quality of life, Other: Gynecological assessment |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patient who underwent a Richter intervention between 01/01/2008 and 31/12/2017 in the Gynecology Department of Foch Hospital
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| Satisfaction assessmentPatient will be asked to assess their satisfaction concerning the Richter procedure and its long term effect | Other | Patients who had Richter intervention |
| Quality of lifeThe Quality of life will be assessed with 3 questionnaires (I-Qol / PISQ-12/PFDI-20) | Other | Patients who had Richter intervention |
| Gynecological assessmentAn optional gynecological consult is proposed to the patients to better estimate the gynecological long-term impact of the procedure | Other | Patients who had Richter intervention |
Primary outcome
Long-term satisfaction of the Richter procedure
Time frame: 4 months
It will be ask to the patients to evaluate their satisfaction of the procedure, base on a 4-answer scale ("Not at all satisfied", "Not very satisfied", "Moderately satisfied", "Fully satisfied")
2 secondary outcomes
Long term anatomic impact of the procedure
Time frame: 7 months
Post-operative complications
Time frame: 7 months
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 16 May 2019.
- 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.
Angeline Favre-Inhofer principal investigator
Hôpital Foch
Jean-Marc Ayoubi study director
Hôpital Foch
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Satisfaction assessment, Quality of life and Gynecological assessment in people with Genital Prolapse, run by Hopital Foch 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 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: finished, as of the sponsor's last update on 16 May 2019. 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?
Long-term satisfaction of the Richter procedure (time frame: 4 months). 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 16 May 2019.