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| Name | Class |
|---|---|
| Coloplast A/S | INDUSTRY |
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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.
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| pelvic organ prolapse repair | Procedure | Surgery to repair pelvic organ prolapse through the vagina using stitches with the addition of surgical mesh. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients With a Composite Outcome : Bladder Wound, Rectum Wound, Abnormal Bleeding | Perioperative morbidity | up to 30 days after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients With Early Complications | Urinary retention, urinary tract infection, hematoma, ureteral complication, second surgery | up to 30 days after surgery |
| Number of Patients With Late Complications |
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Inclusion Criteria:
Exclusion Criteria:
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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
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| Name | Affiliation | Role |
|---|---|---|
| Philippe Ferry, MD | Groupe Hospitalier de la Rochelle Ré Aunis | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CH Dunkerque | Grande-Synthe | France | ||||
| Groupe Hospitalier de la Rochelle Ré Aunis |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27595623 | Background | 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. | |
| 23298608 |
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Patients were excluded if they did not attend their follow up visit within 30 days of surgery.
Between January 2013 and December 2016, in 10 secondary and tertiary French care centres
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| ID | Title | Description |
|---|---|---|
| FG000 | Pelvic Organ Prolapse Repair | Adult women who had vaginal repair of pelvic organ prolapse (recurrent or not) planned with anterior Restorelle® Direct FixTM mesh (with or without posterior mesh) |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
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| ID | Title | Description |
|---|---|---|
| BG000 | Pelvic Organ Prolapse Repair | Adult women who had vaginal repair of pelvic organ prolapse (recurrent or not) planned with anterior Restorelle® Direct FixTM mesh (with or without posterior mesh) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Patients With a Composite Outcome : Bladder Wound, Rectum Wound, Abnormal Bleeding | Perioperative morbidity | Posted | Count of Participants | Participants | up to 30 days after surgery |
|
|
The median follow-up was 3 months ranging from 1 to 36 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Pelvic Organ Prolapse Repair | Adult women who had vaginal repair of pelvic organ prolapse (recurrent or not) planned with anterior Restorelle® Direct FixTM mesh (with or without posterior mesh) |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Ureteral injury | Renal and urinary disorders | MedDRA | Systematic Assessment | perioperative complication |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bladder injury | Renal and urinary disorders | MedDRA | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Philippe Ferry | Groupe Hospitalier de la Rochelle Ré Aunis | +33 5 46 45 50 50 | philippe.ferry@ch-larochelle.fr |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 20, 2016 | Nov 24, 2017 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Mar 3, 2017 | Feb 18, 2019 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D056887 | Pelvic Organ Prolapse |
| ID | Term |
|---|---|
| D011391 | Prolapse |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
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self-catheterization, recurrent urinary tract infections, de novo urinary stress incontinence, chronic pain, vaginal prosthesis exposure, prolapse recurrence, secondary surgery, other
| 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) | 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) | up to 4 years after surgery |
| Number of Patients With Preoperative Urinary Signs | urinary stress incontinence, overactive bladder, dysuria, masked urinary incontinence | within 4 weeks before surgery |
| Number of Patients With Postoperative Urinary Signs | urinary stress incontinence, overactive bladder, dysuria, masked urinary incontinence | up to 4 years after surgery |
| Number of Patients With Preoperative Digestive Signs | dyschezia, incontinence | within 4 weeks before surgery |
| Number of Patients With Postoperative Digestive Signs | dyschezia, incontinence | up to 4 years after surgery |
| Number of Patients With Preoperative Active Sexuality | Patients reporting active sexuality | within 4 weeks before surgery |
| Number of Patients With Preoperative Dyspareunia | Patients reporting pain | within 4 weeks before surgery |
| Number of Patients With Postoperative Active Sexuality | Patients reporting active sexuality | up to 4 years after surgery |
| Number of Patients With Postoperative Dyspareunia | Patients reporting pain | 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) | 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) | up to 48 hours after surgery |
| La Rochelle |
| France |
| Clinique Saint Ame | Lambres-lez-Douai | France |
| CH de Laon | Laon | France |
| Clinique Jules Verne | Nantes | France |
| CHU Nîmes | Nîmes | France |
| Hôpital des Diaconesses | Paris | France |
| Hôpital Kremlin-Bicêtre | Paris | France |
| CH de Cornouaille | Quimper | France |
| Clinique St Michel et St Anne | Quimper | France |
| Polyclinique de Courlancy | Reims | France |
| Clinique la Sagesse | Rennes | France |
| CH Robert Pax | Sarreguemines | France |
| Agyl | Strasbourg | France |
| Hôpital Foch | Suresnes | France |
| Hôpitaux du Léman | Thonon-les-Bains | France |
| Background |
| Khunda 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. |
| 9083302 | Background | Olsen 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. |
| 18799443 | Background | Nygaard 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. |
| 21505577 | Background | Persu 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. |
| 19969258 | Background | Lousquy 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. |
| 26858090 | Background | Maher 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. |
| 29920380 | Result | Ferry 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. |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Secondary and tertiary French care centres | Number | participants |
|
| Body mass index | Median | Full Range | kg/m^2 |
|
| Parity | Median | Full Range | children |
|
| Post menopause | Count of Participants | Participants |
|
| Hormone replacement therapy | Count of Participants | Participants |
|
| Previous hysterectomy | Count of Participants | Participants |
|
| Previous pelvic organ prolapse surgery | Count of Participants | Participants |
|
| Previous incontinence surgery | Count of Participants | Participants |
|
| Procedure | Count of Participants | Participants |
|
|
| Secondary | Number of Patients With Early Complications | Urinary retention, urinary tract infection, hematoma, ureteral complication, second surgery | Posted | Count of Participants | Participants | up to 30 days after surgery |
|
|
|
| Secondary | 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 | Posted | Count of Participants | Participants | up to 4 years after surgery |
|
|
|
| Secondary | 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) | Data was collected retrospectively and few pelvic organ prolapse stage were not available | Posted | Count of Participants | Participants | preoperative, within 48 hours before surgery |
|
|
|
| Secondary | 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) | Data was collected retrospectively and few pelvic organ prolapse stage were not available | Posted | Count of Participants | Participants | up to 4 years after surgery |
|
|
|
| Secondary | Number of Patients With Preoperative Urinary Signs | urinary stress incontinence, overactive bladder, dysuria, masked urinary incontinence | Data was collected retrospectively and few bladder symptom descriptions were not available | Posted | Count of Participants | Participants | within 4 weeks before surgery |
|
|
|
| Secondary | Number of Patients With Postoperative Urinary Signs | urinary stress incontinence, overactive bladder, dysuria, masked urinary incontinence | Data was collected retrospectively and few bladder symptom descriptions were not available | Posted | Count of Participants | Participants | up to 4 years after surgery |
|
|
|
| Secondary | Number of Patients With Preoperative Digestive Signs | dyschezia, incontinence | Data was collected retrospectively and few bowel symptom descriptions were not available | Posted | Count of Participants | Participants | within 4 weeks before surgery |
|
|
|
| Secondary | Number of Patients With Postoperative Digestive Signs | dyschezia, incontinence | Data was collected retrospectively and few bowel symptom descriptions were not available | Posted | Count of Participants | Participants | up to 4 years after surgery |
|
|
|
| Secondary | Number of Patients With Preoperative Active Sexuality | Patients reporting active sexuality | Posted | Count of Participants | Participants | within 4 weeks before surgery |
|
|
|
| Secondary | Number of Patients With Preoperative Dyspareunia | Patients reporting pain | Posted | Count of Participants | Participants | within 4 weeks before surgery |
|
|
|
| Secondary | Number of Patients With Postoperative Active Sexuality | Patients reporting active sexuality | Posted | Count of Participants | Participants | up to 4 years after surgery |
|
|
|
| Secondary | Number of Patients With Postoperative Dyspareunia | Patients reporting pain | Posted | Count of Participants | Participants | up to 4 years after surgery |
|
|
|
| Secondary | Preoperative Score at Numeric Pain Rating Scale | The numeric pain rating scale ranges from 0 (no pain) to 10 (worst pain imaginable) | Posted | Mean | Standard Deviation | units on a scale | Within 48 hours before surgery |
|
|
|
| Secondary | Postoperative Score at Numeric Pain Rating Scale | The numeric pain rating scale ranges from 0 (no pain) to 10 (worst pain imaginable) | Posted | Mean | Standard Deviation | units on a scale | up to 48 hours after surgery |
|
|
|
| 0 |
| 272 |
| 14 |
| 272 |
| 136 |
| 272 |
|
| Urinary tract infection | Renal and urinary disorders | MedDRA | Systematic Assessment | perioperative complication |
|
| Postoperative haematoma | Renal and urinary disorders | MedDRA | Systematic Assessment | postoperative complication in the month following the surgery |
|
| 3rd degree vaginal prolapse | Renal and urinary disorders | MedDRA | Systematic Assessment | Of the 272 patients included, 220 were reviewed at more than one month postoperatively. The description of adverse events is therefore only available for these patients. |
|
| Adverse local tissue reaction around prosthesis | Renal and urinary disorders | MedDRA | Systematic Assessment | Of the 272 patients included, 220 were reviewed at more than one month postoperatively. The description of adverse events is therefore only available for these patients. |
|
| Rectal injury | Renal and urinary disorders | MedDRA | Systematic Assessment |
|
| Urinary retention postoperative | Renal and urinary disorders | MedDRA | Systematic Assessment |
|
| Pain | Renal and urinary disorders | MedDRA | Systematic Assessment |
|
| Urinary tract infection | Renal and urinary disorders | MedDRA | Systematic Assessment |
|
| Postoperative haematoma | Renal and urinary disorders | MedDRA | Systematic Assessment |
|
| Chronic pain | Renal and urinary disorders | MedDRA | Systematic Assessment | Of the 272 patients included, 220 were reviewed at more than one month postoperatively. The description of adverse events is therefore only available for these patients. |
|
| Adverse local tissue reaction around prosthesis | Renal and urinary disorders | MedDRA | Systematic Assessment | Of the 272 patients included, 220 were reviewed at more than one month postoperatively. The description of adverse events is therefore only available for these patients. |
|
| Medical device site granuloma | Renal and urinary disorders | MedDRA | Systematic Assessment | Of the 272 patients included, 220 were reviewed at more than one month postoperatively. The description of adverse events is therefore only available for these patients. |
|
| Incontinence | Renal and urinary disorders | MedDRA | Systematic Assessment | Of the 272 patients included, 220 were reviewed at more than one month postoperatively. The description of adverse events is therefore only available for these patients. |
|
| 1st degree vaginal prolapse | Renal and urinary disorders | MedDRA | Systematic Assessment | Of the 272 patients included, 220 were reviewed at more than one month postoperatively. The description of adverse events is therefore only available for these patients. |
|
| Dyspareunia | Renal and urinary disorders | MedDRA | Systematic Assessment | Of the 272 patients included, 220 were reviewed at more than one month postoperatively. The description of adverse events is therefore only available for these patients. |
|
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| Stage 2 |
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| Stage 3 |
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| Stage 4 |
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| Apex |
|
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| Rectocele |
|
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| Stage 2 |
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| Stage 3 |
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| Stage 4 |
|
| Apex |
|
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| Rectocele |
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| Voiding dysfunction |
|
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| Occult urinary incontinence |
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| Voiding dysfunction |
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