Pelvic Organ ProlapseRestorelleNCT03098641
Smartmesh Technology in Pelvic Floor Repair Procedures
An observational study of Pelvic Organ Prolapse, run by Groupe Hospitalier de la Rochelle Ré Aunis at 16 sites in France.
Trial summary
Pelvic organ prolapse repair involves conservative treatments and surgical treatments. Conservative treatments are for patients with moderate prolapse. Treatment of symptomatic prolapse remains essentially surgical. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Pelvic Organ Prolapse
- What is being tested?
- pelvic organ prolapse repair
- Type of treatment
- Surgery or procedure
- How many people
- 272 participants
- Where
- 16 sitesFrance
- Study dates
- 1 May 2017to 26 Sep 2017
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
Study population: Adult women who underwent surgery to repair pelvic organ prolapse (recurrent or not) through the vagina with the addition of anterior and/or posterior Restorelle Direct Fix prosthesis
Who may be able to join
- Over 18
- woman who underwent surgery to repair pelvic organ prolapse (recurrent or not) through the vagina with the addition of anterior and/or posterior Restorelle Direct Fix prosthesis
- informed and not opposed to the use of her data
Who cannot join
- Opposed to the use of her data
Trial locations and contacts
16 sites in 1 country.
16 sites in 1 country
France16 sites
CH Dunkerque
Grande-Synthe
Groupe Hospitalier de la Rochelle Ré Aunis
La Rochelle
Clinique Saint Ame
Lambres-lez-Douai
CH de Laon
Laon
Clinique Jules Verne
Nantes
CHU Nîmes
Nîmes
Hôpital des Diaconesses
Paris
Hôpital Kremlin-Bicêtre
Paris
CH de Cornouaille
Quimper
Clinique St Michel et St Anne
Quimper
Polyclinique de Courlancy
Reims
Clinique la Sagesse
Rennes
CH Robert Pax
Sarreguemines
Agyl
Strasbourg
Hôpital Foch
Suresnes
Hôpitaux du Léman
Thonon-les-Bains
About this study
Official title: Transvaginal Treatment of Anterior and Apical Genital Prolapses Using an Ultra Lightweight Mesh: Restorelle® Direct FixTM: a Retrospective Study on Feasibility and Morbidity.
Pelvic organ prolapse repair involves conservative treatments and surgical treatments. Conservative treatments are for patients with moderate prolapse. Treatment of symptomatic prolapse remains essentially surgical. According to detailed medical history and a thorough physical exam, surgical techniques may be performed by high abdominal, low vaginal or mixed routes with or without the use of a reinforcing implant. Restorelle Direct Fix is indicated for transvaginal anterior and posterior surgical repair either as mechanical support or as reinforcement of pelvic floor defects. Advantages and disadvantages of vaginal prostheses are known but only limited data have been reported on the use of Restorelle® in the treatment of pelvic organ prolapse. This study is designed to collect data on the safety and efficacy of Restorelle® Direct Fix in pelvic organ prolapse repair.
Read the detailed description
Between January 2013 and December 2016, in the participating centers, all adult women who underwent surgery to repair pelvic organ prolapse (recurrent or not) through the vagina with the addition of anterior and/or posterior Restorelle Direct Fix prosthesis are eligible. Collected data are about the peri-operative period and the data available at the last consultation.
- Conditions
- Pelvic Organ Prolapse
- Being tested
- pelvic organ prolapse repair
- 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.
pelvic organ prolapse repairProcedure or surgery
Surgery to repair pelvic organ prolapse through the vagina using stitches with the addition of surgical mesh.
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Patients With a Composite Outcome : Bladder Wound, Rectum Wound, Abnormal Bleeding
Perioperative morbidity
Measured: up to 30 days after surgery
Secondary outcomes (14)
Number of Patients With Early Complications
Urinary retention, urinary tract infection, hematoma, ureteral complication, second surgery
Measured: up to 30 days after surgery
Number of Patients With Late Complications
self-catheterization, recurrent urinary tract infections, de novo urinary stress incontinence, chronic pain, vaginal prosthesis exposure, prolapse recurrence, secondary surgery, other
Measured: up to 4 years after surgery
Pelvic Organ Prolapse Quantification (POP-Q) Exam Before Surgery
Pelvic organ prolapse quantification (POP-Q) Staging Criteria Prolapse is staged using POP-Q criteria that can range from good support (no organ descent) reported as a POP-Q stage 0 or I to a POP-Q score of IV (complete procidentia or vault eversion)
Measured: preoperative, within 48 hours before surgery
Pelvic Organ Prolapse Quantification (POP-Q) Exam After Surgery
Pelvic organ prolapse quantification (POP-Q) Staging Criteria Prolapse is staged using POP-Q criteria that can range from good support (no organ descent) reported as a POP-Q stage 0 or I to a POP-Q score of IV (complete procidentia or vault eversion)
Measured: up to 4 years after surgery
Number of Patients With Preoperative Urinary Signs
urinary stress incontinence, overactive bladder, dysuria, masked urinary incontinence
Measured: within 4 weeks before surgery
Number of Patients With Postoperative Urinary Signs
urinary stress incontinence, overactive bladder, dysuria, masked urinary incontinence
Measured: up to 4 years after surgery
Number of Patients With Preoperative Digestive Signs
dyschezia, incontinence
Measured: within 4 weeks before surgery
Number of Patients With Postoperative Digestive Signs
dyschezia, incontinence
Measured: up to 4 years after surgery
Number of Patients With Preoperative Active Sexuality
Patients reporting active sexuality
Measured: within 4 weeks before surgery
Number of Patients With Preoperative Dyspareunia
Patients reporting pain
Measured: within 4 weeks before surgery
Number of Patients With Postoperative Active Sexuality
Patients reporting active sexuality
Measured: up to 4 years after surgery
Number of Patients With Postoperative Dyspareunia
Patients reporting pain
Measured: up to 4 years after surgery
Preoperative Score at Numeric Pain Rating Scale
The numeric pain rating scale ranges from 0 (no pain) to 10 (worst pain imaginable)
Measured: Within 48 hours before surgery
Postoperative Score at Numeric Pain Rating Scale
The numeric pain rating scale ranges from 0 (no pain) to 10 (worst pain imaginable)
Measured: up to 48 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2017
- Study start1 May 2017
- Primary completion26 Sep 2017
- Study completion26 Sep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (8)Papers the sponsor has linked to this study.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 272 participants (actual)
Sponsor and investigators
- Lead sponsor
- Groupe Hospitalier de la Rochelle Ré Aunis
- Sponsor type
- University, hospital or other
- Collaborators
- Coloplast A/S
- Responsible party
- Sponsor
- Investigators
- Philippe Ferry, MD, Study director, Groupe Hospitalier de la Rochelle Ré Aunis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03098641
- Sponsor's protocol ID
- 2016/P05/179
- Acronym
- Restorelle
- Status last verified
- Oct 2023
- First submitted
- 28 Mar 2017
- Last updated
- 13 Nov 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Le Normand L, Cosson M, Cour F, Deffieux X, Donon L, Ferry P, Fatton B, Hermieu JF, Marret H, Meurette G, Cortesse A, Wagner L, Fritel X. [Clinical practice guidelines: Summary of recommendations for first surgical treatment of female pelvic organ prolapse by 5 French academic societies: AFU, CNGOF, SIFUD-PP, SNFCP, and SCGP]. Prog Urol. 2016 Jul;26 Suppl 1:S1-7. doi: 10.1016/S1166-7087(16)30424-9. French.
PubMed 27595623Khunda A, Vashisht A, Cutner A. New procedures for uterine prolapse. Best Pract Res Clin Obstet Gynaecol. 2013 Jun;27(3):363-79. doi: 10.1016/j.bpobgyn.2012.12.004. Epub 2013 Jan 5.
PubMed 23298608Olsen AL, Smith VJ, Bergstrom JO, Colling JC, Clark AL. Epidemiology of surgically managed pelvic organ prolapse and urinary incontinence. Obstet Gynecol. 1997 Apr;89(4):501-6. doi: 10.1016/S0029-7844(97)00058-6.
PubMed 9083302Nygaard I, Barber MD, Burgio KL, Kenton K, Meikle S, Schaffer J, Spino C, Whitehead WE, Wu J, Brody DJ; Pelvic Floor Disorders Network. Prevalence of symptomatic pelvic floor disorders in US women. JAMA. 2008 Sep 17;300(11):1311-6. doi: 10.1001/jama.300.11.1311.
PubMed 18799443Persu C, Chapple CR, Cauni V, Gutue S, Geavlete P. Pelvic Organ Prolapse Quantification System (POP-Q) - a new era in pelvic prolapse staging. J Med Life. 2011 Jan-Mar;4(1):75-81. Epub 2011 Feb 25.
PubMed 21505577Lousquy R, Costa P, Delmas V, Haab F. [Update on the epidemiology of genital prolapse]. Prog Urol. 2009 Dec;19(13):907-15. doi: 10.1016/j.purol.2009.09.011. Epub 2009 Nov 4. French.
PubMed 19969258Maher C, Feiner B, Baessler K, Christmann-Schmid C, Haya N, Marjoribanks J. Transvaginal mesh or grafts compared with native tissue repair for vaginal prolapse. Cochrane Database Syst Rev. 2016 Feb 9;2(2):CD012079. doi: 10.1002/14651858.CD012079.
PubMed 26858090Ferry P, Bertherat P, Gauthier A, Villet R, Del Piano F, Hamid D, Fernandez H, Broux PL, Salet-Lizee D, Vincens E, Ntshaykolo P, Debodinance P, Pocholle P, Thirouard Y, de Tayrac R. Transvaginal treatment of anterior and apical genital prolapses using an Ultra lightweight mesh: Restorelle(R) Direct Fix. A retrospective study on feasibility and morbidity. J Gynecol Obstet Hum Reprod. 2018 Nov;47(9):443-449. doi: 10.1016/j.jogoh.2018.06.001. Epub 2018 Jun 18.
PubMed 29920380
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transvaginal Treatment of Anterior and Apical Genital Prolapses Using an Ultra Lightweight Mesh: Restorelle® Direct FixTM: a Retrospective Study on Feasibility and Morbidity.
- ClinicalTrials.gov ID
- NCT03098641
- Acronym / sponsor ID
- Restorelle / 2016/P05/179
- Conditions
- Pelvic Organ Prolapse
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 272 participants (actual)
- Lead sponsor
- Groupe Hospitalier de la Rochelle Ré AunisUniversity, hospital or other
- Collaborators
- Coloplast A/S
- Study start
- 1 May 2017 (actual)
- Primary completion
- 26 Sep 2017 (actual)
- Study completion
- 26 Sep 2017 (actual)
- First posted
- 4 Apr 2017 (actual)
- Results
- Posted 3 Jun 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Pelvic organ prolapse repair involves conservative treatments and surgical treatments. Conservative treatments are for patients with moderate prolapse. Treatment of symptomatic prolapse remains essentially surgical. According to detailed medical history and a thorough physical exam, surgical techniques may be performed by high abdominal, low vaginal or mixed routes with or without the use of a reinforcing implant. Restorelle Direct Fix is indicated for transvaginal anterior and posterior surgical repair either as mechanical support or as reinforcement of pelvic floor defects. Advantages and disadvantages of vaginal prostheses are known but only limited data have been reported on the use of Restorelle® in the treatment of pelvic organ prolapse. This study is designed to collect data on the safety and efficacy of Restorelle® Direct Fix in pelvic organ prolapse repair.
Detailed description
Between January 2013 and December 2016, in the participating centers, all adult women who underwent surgery to repair pelvic organ prolapse (recurrent or not) through the vagina with the addition of anterior and/or posterior Restorelle Direct Fix prosthesis are eligible. Collected data are about the peri-operative period and the data available at the last consultation.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult women who underwent surgery to repair pelvic organ prolapse (recurrent or not) through the vagina with the addition of anterior and/or posterior Restorelle Direct Fix prosthesis
Key inclusion criteria (3 listed)
- Over 18
- woman who underwent surgery to repair pelvic organ prolapse (recurrent or not) through the vagina with the addition of anterior and/or posterior Restorelle Direct Fix prosthesis
- informed and not opposed to the use of her data
Key exclusion criteria (1 listed)
- Opposed to the use of her data
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 |
|---|---|---|
| pelvic organ prolapse repairSurgery to repair pelvic organ prolapse through the vagina using stitches with the addition of surgical mesh. | Procedure or surgery | – |
Primary outcome
Number of Patients With a Composite Outcome : Bladder Wound, Rectum Wound, Abnormal Bleeding
Time frame: up to 30 days after surgery
Perioperative morbidity
14 secondary outcomes
Number of Patients With Early Complications
Time frame: up to 30 days after surgery
Number of Patients With Late Complications
Time frame: up to 4 years after surgery
Pelvic Organ Prolapse Quantification (POP-Q) Exam Before Surgery
Time frame: preoperative, within 48 hours before surgery
Pelvic Organ Prolapse Quantification (POP-Q) Exam After Surgery
Time frame: up to 4 years after surgery
Number of Patients With Preoperative Urinary Signs
Time frame: within 4 weeks before surgery
Number of Patients With Postoperative Urinary Signs
Time frame: up to 4 years after surgery
Number of Patients With Preoperative Digestive Signs
Time frame: within 4 weeks before surgery
Number of Patients With Postoperative Digestive Signs
Time frame: up to 4 years after surgery
Number of Patients With Preoperative Active Sexuality
Time frame: within 4 weeks before surgery
Number of Patients With Preoperative Dyspareunia
Time frame: within 4 weeks before surgery
Number of Patients With Postoperative Active Sexuality
Time frame: up to 4 years after surgery
Number of Patients With Postoperative Dyspareunia
Time frame: up to 4 years after surgery
Preoperative Score at Numeric Pain Rating Scale
Time frame: Within 48 hours before surgery
Postoperative Score at Numeric Pain Rating Scale
Time frame: up to 48 hours after surgery
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 27595623Le Normand L, Cosson M, Cour F, Deffieux X, Donon L, Ferry P, Fatton B, Hermieu JF, Marret H, Meurette G, Cortesse A, Wagner L, Fritel X. [Clinical practice guidelines: Summary of recommendations for first surgical treatment of female pelvic organ prolapse by 5 French academic societies: AFU, CNGOF, SIFUD-PP, SNFCP, and SCGP]. Prog Urol. 2016 Jul;26 Suppl 1:S1-7. doi: 10.1016/S1166-7087(16)30424-9. French.
- Background: PubMed 23298608Khunda A, Vashisht A, Cutner A. New procedures for uterine prolapse. Best Pract Res Clin Obstet Gynaecol. 2013 Jun;27(3):363-79. doi: 10.1016/j.bpobgyn.2012.12.004. Epub 2013 Jan 5.
- Background: PubMed 9083302Olsen AL, Smith VJ, Bergstrom JO, Colling JC, Clark AL. Epidemiology of surgically managed pelvic organ prolapse and urinary incontinence. Obstet Gynecol. 1997 Apr;89(4):501-6. doi: 10.1016/S0029-7844(97)00058-6.
- Background: PubMed 18799443Nygaard I, Barber MD, Burgio KL, Kenton K, Meikle S, Schaffer J, Spino C, Whitehead WE, Wu J, Brody DJ; Pelvic Floor Disorders Network. Prevalence of symptomatic pelvic floor disorders in US women. JAMA. 2008 Sep 17;300(11):1311-6. doi: 10.1001/jama.300.11.1311.
- Background: PubMed 21505577Persu C, Chapple CR, Cauni V, Gutue S, Geavlete P. Pelvic Organ Prolapse Quantification System (POP-Q) - a new era in pelvic prolapse staging. J Med Life. 2011 Jan-Mar;4(1):75-81. Epub 2011 Feb 25.
- Background: PubMed 19969258Lousquy R, Costa P, Delmas V, Haab F. [Update on the epidemiology of genital prolapse]. Prog Urol. 2009 Dec;19(13):907-15. doi: 10.1016/j.purol.2009.09.011. Epub 2009 Nov 4. French.
- Background: PubMed 26858090Maher C, Feiner B, Baessler K, Christmann-Schmid C, Haya N, Marjoribanks J. Transvaginal mesh or grafts compared with native tissue repair for vaginal prolapse. Cochrane Database Syst Rev. 2016 Feb 9;2(2):CD012079. doi: 10.1002/14651858.CD012079.
- Results publication: PubMed 29920380Ferry P, Bertherat P, Gauthier A, Villet R, Del Piano F, Hamid D, Fernandez H, Broux PL, Salet-Lizee D, Vincens E, Ntshaykolo P, Debodinance P, Pocholle P, Thirouard Y, de Tayrac R. Transvaginal treatment of anterior and apical genital prolapses using an Ultra lightweight mesh: Restorelle(R) Direct Fix. A retrospective study on feasibility and morbidity. J Gynecol Obstet Hum Reprod. 2018 Nov;47(9):443-449. doi: 10.1016/j.jogoh.2018.06.001. Epub 2018 Jun 18.
- Individual participant dataSharing planned: Undecided
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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.
Philippe Ferry, MD study director
Groupe Hospitalier de la Rochelle Ré Aunis
16 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pelvic Organ Prolapse, run by Groupe Hospitalier de la Rochelle Ré Aunis at 16 sites 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 3 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 13 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites 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?
Yes. Results are posted in the registry (first posted 3 Jun 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Patients With a Composite Outcome : Bladder Wound, Rectum Wound, Abnormal Bleeding (time frame: up to 30 days after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03098641, which also lists 8 linked publications.
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 Nov 2023; AzTrials last refreshed its copy on 29 Oct 2026.