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Pelvic Organ ProlapseNCT00521066

GYNECARE PROSIMA* Pelvic Floor Repair System for Pelvic Organ Prolapse

An observational study of Pelvic Organ Prolapse, run by Ethicon, Inc. at 11 sites in 4 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to is to evaluate the success of the GYNECARE PROSIMA* system in women with symptoms for pelvic organ prolapse (POP) requiring surgical correction of POP. (*TRADEMARK) 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?
GYNECARE PROSIMA* Pelvic Floor Repair System
Type of treatment
Medical device
How many people
150 participants
Where
11 sitesin 4 countries
Study dates
Jun 2007to Jun 2010
Phase
Observational
Are there results?
None posted in the registry

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: Women over 18 with symptomatic pelvic organ prolapse of ICS POP-Q Stage II or III, suitable for surgical repair

Who may be able to join

  • Candidates with symptomatic pelvic organ prolapse of ICS POP-Q Stage II or III, suitable for surgical repair. Vaginal hysterectomy, perineal repair and/or mid urethral sling procedures for incontinence may be performed concurrently.
  • Age ≥ 18 years.
  • Agrees to participate in the study, including completion of all study-related procedures, evaluations and questionnaires, and documents this agreement by signing the Ethics Committee / IRB approved informed consent.

Who cannot join

  • Additional surgical intervention concurrent to the PROSIMA procedure (e.g. sacrocolpopexy, paravaginal repair, tubal sterilisation).
  • Previous repair of pelvic organ prolapse involving insertion of mesh.
  • Previous hysterectomy within 6 months of scheduled surgery.
  • Experimental drug or experimental medical device within 3 months prior to the planned procedure.
  • Active genital, urinary or systemic infection at the time of the surgical procedure. Surgery may be delayed in such subjects until the infection is cleared.
  • Coagulation disorder or on therapeutic anticoagulant therapy at the time of surgery.
Show all 11Show fewer
  • History of chemotherapy or pelvic radiation therapy.
  • Systemic disease known to affect bladder or bowel function (e.g. Parkinson's disease, multiple sclerosis, spina bifida, spinal cord injury or trauma).
  • Current evaluation or treatment for chronic pelvic pain (e.g. interstitial cystitis, endometriosis, coccydynia, vulvodynia).
  • Nursing or pregnant or intends future pregnancy.
  • In the investigator's opinion, any medical condition or psychiatric illness that could potentially be life threatening or affect their ability to complete the study visits according to this protocol.

Trial locations and contacts

11 sites in 4 countries.

11 sites in 4 countries

United States5 sites

  • The Institute for Female Pelvic Medicine & Reconstructive Surgery

    Allentown, Pennsylvania, 18104

  • Female Pelvic Medicine and Urogynecology Institute of Michigan

    Dearborn, Michigan, 48124

  • Female Pelvic Medicine & Urogynecology

    Grand Rapids, Michigan, 49506

  • Specialists in Urology

    Naples, Florida, 34102

  • Magee Women's Hospital of the Universtiy of Pittsburgh

    Pittsburgh, Pennsylvania, 15213

Other trials in United States

United Kingdom3 sites

  • Addenbrookes Hospital

    Cambridge, CB2 0QQ

  • North Hampshire Hospital

    Hampshire, RG24 9NA

  • St. Mary's Hospital

    Manchester, M13 0JH

Other trials in United Kingdom

Germany2 sites

  • Bereich Urogynakologie

    Halle, 06097

  • Universitatsklinik Tubingen

    Tübingen, 72076

Other trials in Germany

Australia1 site

  • Royal Women's Hospital

    Melbourne, 3053

Other trials in Australia

About this study

Official title: A Prospective, Multi-centre Study to Evaluate the Clinical Performance of the GYNECARE PROSIMA* Pelvic Floor Repair System as a Procedure for Pelvic Organ Prolapse

The purpose of this study is to is to evaluate the success of the GYNECARE PROSIMA* system in women with symptoms for pelvic organ prolapse (POP) requiring surgical correction of POP.

(*TRADEMARK)

Read the detailed description

The GYNECARE PROSIMA* system provides a simplified mesh repair, avoiding the need for dissection outside the pelvic cavity.

Being tested
GYNECARE PROSIMA* Pelvic Floor Repair System
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.

  • GYNECARE PROSIMA* Pelvic Floor Repair SystemDevice

    Also called mesh pelvic floor repari

    procedure for pelvic organ prolapse

Study groups in NCT00521066
Study groupRoleWhat they receive
1Prosima Pelvic Floor Repair System
Receives: Device: GYNECARE PROSIMA* Pelvic Floor Repair System

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Success based on overall POP-Q score at 12 months post-procedure.

    Success is determined by achievement of an overall POP-Q score of ICS Stage ≤1, without further re-intervention for POP.

    Measured: 12-months

Secondary outcomes (52)

  1. Success based on overall POP-Q score at 24 months post-procedure.

    Success is determined by achievement of an overall POP-Q score of ICS Stage ≤1, without further re-intervention for POP

    Measured: 24 months

  2. Success based on treated compartment ICS POP-Q stage

    Success will be determined by achievement of treated compartment POP-Q score of ICS Stage ≤1, without further re-intervention for POP.

    Measured: 12 months

  3. Success based on treated compartment ICS POP-Q stage

    Success will be determined by achievement of treated compartment POP-Q score of ICS Stage ≤1, without further re-intervention for POP.

    Measured: 24 months

  4. Success defined as the leading edge within the hymen

    Success defined as the leading edge within the hymen (i.e. all POP-Q values to be less than 0, without further re-intervention for POP)

    Measured: 12 months

  5. Success defined as the leading edge within the hymen

    Success defined as the leading edge within the hymen (i.e. all POP-Q values to be less than 0, without further re-intervention for POP)

    Measured: 24 months

  6. Mean PFDI-20 score

    Measured: 12 months

  7. Mean PFDI-20 score

    Measured: 24 months

  8. Mean change from baseline in PFDI-20 scores

    Measured: 24 months

  9. Mean change from baseline in PFDI-20 scores

    Measured: 12 months

  10. Mean POPDI score

    POPDI is a sub score of PFDI-20

    Measured: 12 months

  11. Mean POPDI score

    POPDI is a sub score of PFDI-20

    Measured: 24 months

  12. Mean change from baseline in POPDI score

    POPDI is a sub scores of PFDI-20

    Measured: 12 months

  13. Mean change from baseline in POPDI score

    POPDI is a sub score of PFDI-20

    Measured: 24 months

  14. Mean CRADI score

    CRADI is a sub score of PFDI-20

    Measured: 12 months

  15. Mean CRADI score

    CRADI is a sub score of PFDI-20

    Measured: 24 months

  16. Mean change from baseline in CRADI score

    CRADI is a sub score of PFDI-20

    Measured: 12 months

  17. Mean change from baseline in CRADI score

    CRADI is a sub score of PFDI-20

    Measured: 24 months

  18. Mean UDI score

    UDI is a sub score of PFDI-20

    Measured: 12 months

  19. Mean UDI score

    UDI is a sub score of PFDI-20

    Measured: 24 months

  20. Mean change from baseline in UDI score

    UDI is a sub score of PFDI-20

    Measured: 12 months

  21. Mean change from baseline in UDI score

    UDI is a sub score of PFDI-20

    Measured: 24 months

  22. EuroQol (EQ-5D health state) change from baseline

    Measured: 12 months

  23. EuroQol (EQ-5D health state) change from baseline

    Measured: 24 months

  24. Mean PFIQ-7 score

    Measured: 12 months

  25. Mean PFIQ-7 score

    Measured: 24 months

  26. Mean change from baseline in PFIQ-7 score

    Measured: 12 months

  27. Mean change from baseline in PFIQ-7 score

    Measured: 24 months

  28. Mean POPIQ score

    POPIQ is a sub-score of PFIQ-7

    Measured: 12 months

  29. Mean POPIQ score

    POPIQ is a sub-score of PFIQ-7

    Measured: 24 months

  30. Mean change from baseline in POPIQ score

    POPIQ is a sub-score of PFIQ-7

    Measured: 12 months

  31. Mean change from baseline in POPIQ score

    POPIQ is a sub-score of PFIQ-7

    Measured: 24 months

  32. Mean CRAIQ score

    CRAIQ is a sub-score of PFIQ-7

    Measured: 12 months

  33. Mean CRAIQ score

    CRAIQ is a sub-score of PFIQ-7

    Measured: 24 months

  34. Mean change from baseline in CRAIQ score

    CRAIQ is a sub-score of PFIQ-7

    Measured: 12 months

  35. Mean change from baseline in CRAIQ score

    CRAIQ is a sub-score of PFIQ-7

    Measured: 24 months

  36. Mean UIQ score

    UIQ is a sub-score of PFIQ-7

    Measured: 12 months

  37. Mean UIQ score

    UIQ is a sub-score of PFIQ-7

    Measured: 24 months

  38. Mean change from baseline in UIQ score

    UIQ is a sub-score of PFIQ-7

    Measured: 12 months

  39. Mean change from baseline in UIQ score

    UIQ is a sub-score of PFIQ-7

    Measured: 24 months

  40. Mean PISQ-12 score

    In subjects sexually active at baseline, assessment of sexual function

    Measured: 12 months

  41. Mean PISQ-12 score

    In subjects sexually active at baseline, assessment of sexual function

    Measured: 24 months

  42. Mean change from baseline in PISQ-12 score

    In subjects sexually active at baseline, assessment of sexual function

    Measured: 12 months

  43. Mean change from baseline in PISQ-12 score

    In subjects sexually active at baseline, assessment of sexual function

    Measured: 24 months

  44. Incidence of new onset dyspareunia, resolution or continuance of pre-existing dyspareunia

    Measured: ongoing

  45. Length of procedure

    From time to first incision to time of last suture used to secure VSD

    Measured: perioperative

  46. Pain score measured using Visual Analog Scale (VAS).

    Measured: 24 hours post surgery and at the 3-4 week visit

  47. Discomfort of balloon removal, measured using VAS at time of removal.

    Measured: 24 hrs post-surgical

  48. Subject perception of VSD: Awareness

    Measured by visual analogue scale

    Measured: 3-4 week visit

  49. Subject perception of VSD: Discomfort

    Measured by visual analogue scale

    Measured: 3-4 week visit

  50. Subject perception of VSD: Acceptability of discharge

    Measured by visual analogue scale

    Measured: 3-4 week visit

  51. Subject global impression

    assessed on a 5 point Likert scale

    Measured: 12 month visit

  52. Subject global impression

    assessed on a 5 point Likert scale

    Measured: 24 month visit

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Aug 2007 (estimated)
  2. Study startJun 2007
  3. Primary completionOct 2008
  4. Study completionJun 2010

Resources

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
Prospective
Enrolment
150 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00521066
Sponsor's protocol ID
300-06-005
Status last verified
May 2014
First submitted
24 Aug 2007
Last updated
6 May 2014
Results posted
No
Data monitoring committee
No

Publications

  • Zyczynski HM, Carey MP, Smith AR, Gauld JM, Robinson D, Sikirica V, Reisenauer C, Slack M; Prosima Study Investigators. One-year clinical outcomes after prolapse surgery with nonanchored mesh and vaginal support device. Am J Obstet Gynecol. 2010 Dec;203(6):587.e1-8. doi: 10.1016/j.ajog.2010.08.001.

    PubMed 20934681

  • Sayer T, Lim J, Gauld JM, Hinoul P, Jones P, Franco N, Van Drie D, Slack M; Prosima Study Investigators. Medium-term clinical outcomes following surgical repair for vaginal prolapse with tension-free mesh and vaginal support device. Int Urogynecol J. 2012 Apr;23(4):487-93. doi: 10.1007/s00192-011-1600-3. Epub 2011 Dec 6.

    PubMed 22143448

Questions about this trial

What is this clinical trial studying?

An observational study of Pelvic Organ Prolapse, run by Ethicon, Inc. at 11 sites in 4 countries.

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 11 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 6 May 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 11 sites in United States, United Kingdom, Germany, Australia. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Success based on overall POP-Q score at 12 months post-procedure. (time frame: 12-months). 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 NCT00521066, which also lists 2 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 6 May 2014.

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