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OpenTrials
Completed

NCT Number: NCT03098641

Smartmesh Technology in Pelvic Floor Repair Procedures

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.

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Key information

Conditions

Pelvic Organ Prolapse Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Prolapse

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

CH Dunkerque, Grande-Synthe, France

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Pelvic organ prolapse repair

Procedure

Surgery to repair pelvic organ prolapse through the vagina using stitches with the addition of surgical mesh.

Primary outcomes

  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 outcomes

  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)

Sponsors and collaborators

Lead sponsor

Groupe Hospitalier de la Rochelle Ré Aunis

Other

Collaborators

  • Coloplast A/S

Registry information

Official study title

Transvaginal Treatment of Anterior and Apical Genital Prolapses Using an Ultra Lightweight Mesh: Restorelle® Direct FixTM: a Retrospective Study on Feasibility and Morbidity.

Acronym: Restorelle

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Apr 4, 2017
Registry last updated
Nov 13, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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