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Completed

NCT Number: NCT01559168

Uphold Mesh for the Surgical Treatment of Uterine-predominant Prolapse

The primary objective of this study is to evaluate the efficacy of the UpholdTM LITE mesh over a 12 month follow up period, using a composite outcome including a good anatomical correction for both anterior and apical compartments (stage 0 or 1), no prolapse (bulge) symptoms (answer "no" at question 3 of the PFDI-20) and no reintervention for recurrent prolapse of the anterior or apical compartment.

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Key information

Age range

50 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

CH Camille Guérin, Châtellerault, France

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About this study

Secondary objectives include the evaluation of the following:

  • Change from baseline of POP-Q scoring at 6 weeks, 6 months and 12 months post procedure, including evolution of treated or non-treated posterior compartments.
  • The proportion of patients with anatomical prolapse (C/D), but who are asymptomatic.
  • Change from baseline of mean quality-of-life scores.
  • Evaluation of mesh properties from procedure date through study period.
  • Peri-operative and post-treatment pain score assessment comparing the various anesthesia regimes used (Visual Analog Scale).
  • Assessment of patient subjective outcomes for overall treatment effects and satisfaction.
  • Objective evaluation of mesh shrinkage by standardized ultrasound measurements.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • The patient must have given his/her informed and signed consent
  • The patient must be insured or beneficiary of a health insurance plan
  • The patient is available for 12 months of follow-up
  • Patients with symptoms and altered quality of life in relation to uterine or post-hysterectomy vault prolapse
  • Patients who are receiving the UpholdTM LITE mesh Kit
  • Female patients >= years who have no desire of future pregnancy
  • Diagnosed with pelvic organ prolapse and >= ICS POP-Q Stage 2 Symptomatic Prolapse apical compartment (uterine or vault), associated with ICS POP-Q Stage 2 or 3 Symptomatic Prolapse anterior compartment (point Ba >= -1
  • Patients willing to complete quality of life questionnaire at baseline (pre-procedure) and at 6 weeks, 6 and 12 months post-procedure

Exclusion criteria

  • The patient is participating in another study
  • The patient is in an exclusion period determined by a previous study
  • The patient is under judicial protection, under tutorship or curatorship
  • The patient refuses to sign the consent
  • It is impossible to correctly inform the patient
  • The patient is pregnant, parturient, or breastfeeding
  • Patients who are not receiving the UpHoldTM LITE mesh Kit
  • Patients < 50 years
  • Patients qho, according to the clinical judgment of the investigator, are not suitable for this study
  • Patients who are considering future pregnancies
  • Patients whose pelvic organ prolapse is a <= 1 ICS Stage
  • Patients requiring Posterior Graft procedure
  • Patients with known or suspected hypersensitivity to polypropylene
  • Patients with any pathology which ould compromise implant placement
  • Patients with any pathology which ould compromise implant placement as mentioned in the device instruction manual
  • Patients with any pathology that would limit blood supply and compromise healing
  • Patients with blood coagulation disorder (associated current level coagulation)
  • Patients with autoimmune connective tissue disease
  • Patients with upper urinary tract obstruction and renal insufficiency
  • Patients with local or systemic infection

Treatment and study plan

UpholdTM LITE placement

Device

Uphold TM LITE mesh is used for the surgical correction of pelvic organ prolapse.

Primary outcomes

  1. Apical anatomical success

    Time frame: 12 months

    Presence/absence: anatomical success as concerns apical (uterine) support, defined as point C <= stage 1 per POP-Q scoreing (ICS)

  2. Anterior vaginal wall anatomical success

    Time frame: 12 months

    Presence/absence: anatomical success on anterior vaginal wall support, defined as point Ba < = stage 1 per POP-Q scoring (ICS)

  3. Change from baseline in PFDI-20 scores

    Time frame: baseline to 12 lines

Secondary outcomes

  1. Anterior vaginal wall anatomical success

    Time frame: 6 months

    Presence/absence: anatomical success on anterior vaginal wall support, defined as point Ba < = stage 1 per POP-Q scoring (ICS)

  2. Apical anatomical success

    Time frame: 6 weeks

    Presence/absence: anatomical success as concerns apical (uterine) support, defined as point C <= stage 1 per POP-Q scoreing (ICS)

  3. Apical anatomical success

    Time frame: 6 months

    Presence/absence: anatomical success as concerns apical (uterine) support, defined as point C <= stage 1 per POP-Q scoreing (ICS)

  4. Anterior vaginal wall anatomical success

    Time frame: 6 weeks

    Presence/absence: anatomical success on anterior vaginal wall support, defined as point Ba < = stage 1 per POP-Q scoring (ICS)

  5. Change from baseline in PFDI-20 scores

    Time frame: baseline to 6 weeks

  6. Change from baseline in PFDI-20 scores

    Time frame: baseline to 6 months

  7. Change from baseline in PFIQ-7 scores

    Time frame: baseline to 6 weeks

  8. Change from baseline in PFIQ-7 scores

    Time frame: baseline to 6 months

  9. Change from baseline in PFIQ-7 scores

    Time frame: baseline to 12 months

  10. Change from baseline in PISQ-12 scores

    Time frame: baseline to 6 months

  11. Change from baseline in PISQ-12 scores

    Time frame: baseline to 12 months

  12. length of hospital stay (days)

    Time frame: 6 weeks

  13. Number of days necessary for return to normal activities

    Time frame: 6 weeks

  14. Visual analog scale for post-operative pain

    Time frame: Day 1

    score ranging from 0.0 to 10.0

  15. Visual analog scale for post-operative pain

    Time frame: 6 weeks

    score ranging from 0.0 to 10.0

  16. Visual analog scale for post-operative pain

    Time frame: 6 months

    score ranging from 0.0 to 10.0

  17. Visual analog scale for post-operative pain

    Time frame: 12 months

    score ranging from 0.0 to 10.0

  18. Mesh related morbidity

    Time frame: Day 1

    Presence/absence of mesh related morbidity (infection, erosion, pain, dyspareunia)

  19. Mesh related morbidity

    Time frame: 6 weeks

    Presence/absence of mesh related morbidity (infection, erosion, pain, dyspareunia)

  20. Mesh related morbidity

    Time frame: 6 months

    Presence/absence of mesh related morbidity (infection, erosion, pain, dyspareunia)

  21. Mesh related morbidity

    Time frame: 12 months

    Presence/absence of mesh related morbidity (infection, erosion, pain, dyspareunia)

  22. Mesh contraction (cm)

    Time frame: 6 weeks

    Mesh contraction as determined by ultrasound measurement (cm)

  23. Mesh contraction (cm)

    Time frame: 6 months

    Mesh contraction as determined by ultrasound measurement (cm)

  24. Mesh contraction (cm)

    Time frame: 12 months

    Mesh contraction as determined by ultrasound measurement (cm)

  25. Patient satisfaction (PGI index) score

    Time frame: 6 weeks

  26. Patient satisfaction (PGI index) score

    Time frame: 6 months

  27. Patient satisfaction (PGI index) score

    Time frame: 12 months

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nīmes

Other

Registry information

Official study title

Clinical Evaluation of the Uphold Mesh for the Surgical Treatment of Uterine-predominant Prolapse: a Prospective, Multicenter Trial

Important dates

Study start
2012
Primary completion
2016
Study completion
2016
First posted
Mar 21, 2012
Registry last updated
Nov 19, 2025

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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