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Smartmesh Technology in Pelvic Floor Repair Procedures (Restorelle)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03098641
Recruitment Status : Completed
First Posted : April 4, 2017
Results First Posted : June 3, 2019
Last Update Posted : June 3, 2019
Sponsor:
Collaborator:
Coloplast A/S
Information provided by (Responsible Party):
Groupe Hospitalier de la Rochelle Ré Aunis

Brief 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. 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.

Condition or disease Intervention/treatment
Pelvic Organ Prolapse Procedure: 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.

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Study Type : Observational
Actual Enrollment : 272 participants
Observational Model: Cohort
Time Perspective: Retrospective
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.
Actual Study Start Date : May 1, 2017
Actual Primary Completion Date : September 26, 2017
Actual Study Completion Date : September 26, 2017

Resource links provided by the National Library of Medicine



Intervention Details:
  • Procedure: pelvic organ prolapse repair
    Surgery to repair pelvic organ prolapse through the vagina using stitches with the addition of surgical mesh.


Primary Outcome Measures :
  1. Number of Patients With a Composite Outcome : Bladder Wound, Rectum Wound, Abnormal Bleeding [ Time Frame: up to 30 days after surgery ]
    Perioperative morbidity


Secondary Outcome Measures :
  1. Number of Patients With Early Complications [ Time Frame: up to 30 days after surgery ]
    Urinary retention, urinary tract infection, hematoma, ureteral complication, second surgery

  2. Number of Patients With Late Complications [ Time Frame: up to 4 years after surgery ]
    self-catheterization, recurrent urinary tract infections, de novo urinary stress incontinence, chronic pain, vaginal prosthesis exposure, prolapse recurrence, secondary surgery, other

  3. Pelvic Organ Prolapse Quantification (POP-Q) Exam Before Surgery [ Time Frame: preoperative, within 48 hours 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)

  4. Pelvic Organ Prolapse Quantification (POP-Q) Exam After Surgery [ Time Frame: up to 4 years 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)

  5. Number of Patients With Preoperative Urinary Signs [ Time Frame: within 4 weeks before surgery ]
    urinary stress incontinence, overactive bladder, dysuria, masked urinary incontinence

  6. Number of Patients With Postoperative Urinary Signs [ Time Frame: up to 4 years after surgery ]
    urinary stress incontinence, overactive bladder, dysuria, masked urinary incontinence

  7. Number of Patients With Preoperative Digestive Signs [ Time Frame: within 4 weeks before surgery ]
    dyschezia, incontinence

  8. Number of Patients With Postoperative Digestive Signs [ Time Frame: up to 4 years after surgery ]
    dyschezia, incontinence

  9. Number of Patients With Preoperative Active Sexuality [ Time Frame: within 4 weeks before surgery ]
    Patients reporting active sexuality

  10. Number of Patients With Preoperative Dyspareunia [ Time Frame: within 4 weeks before surgery ]
    Patients reporting pain

  11. Number of Patients With Postoperative Active Sexuality [ Time Frame: up to 4 years after surgery ]
    Patients reporting active sexuality

  12. Number of Patients With Postoperative Dyspareunia [ Time Frame: up to 4 years after surgery ]
    Patients reporting pain

  13. Preoperative Score at Numeric Pain Rating Scale [ Time Frame: Within 48 hours before surgery ]
    The numeric pain rating scale ranges from 0 (no pain) to 10 (worst pain imaginable)

  14. Postoperative Score at Numeric Pain Rating Scale [ Time Frame: up to 48 hours after surgery ]
    The numeric pain rating scale ranges from 0 (no pain) to 10 (worst pain imaginable)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
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
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Opposed to the use of her data

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03098641


Locations
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France
CH Dunkerque
Grande Synthe, France
Groupe Hospitalier de la Rochelle Ré Aunis
La Rochelle, France
Clinique Saint Ame
Lambres-lez-Douai, France
CH de Laon
Laon, France
Clinique Jules Verne
Nantes, France
CHU Nîmes
Nimes, 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
Sponsors and Collaborators
Groupe Hospitalier de la Rochelle Ré Aunis
Coloplast A/S
Investigators
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Study Director: Philippe Ferry, MD Groupe Hospitalier de la Rochelle Ré Aunis
  Study Documents (Full-Text)

Documents provided by Groupe Hospitalier de la Rochelle Ré Aunis:
Informed Consent Form  [PDF] March 3, 2017

Additional Information:
Publications:

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Responsible Party: Groupe Hospitalier de la Rochelle Ré Aunis
ClinicalTrials.gov Identifier: NCT03098641    
Other Study ID Numbers: 2016/P05/179
First Posted: April 4, 2017    Key Record Dates
Results First Posted: June 3, 2019
Last Update Posted: June 3, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Prolapse
Pelvic Organ Prolapse
Pathological Conditions, Anatomical