An observational study in Cystocele, Rectocele and Enterocele, sponsored by Ethicon, Inc.. Completed at 8 sites in 4 countries. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2014-05-06.
Sponsored by Ethicon, Inc. (part of Johnson & Johnson) · Observational
The purpose of this study is to evaluate the clinical performance of the PROLIFT system with a new lighter-weight mesh in repair of vaginal prolapse.
Vaginal prolapse (a feeling of bulge in the vagina) may cause some distressing symptoms such as loss of control of the bowel or bladder, and may also cause problems with women's sex life. There are a number of different surgical procedures which are used to repair prolapse. Sometimes a mesh is placed in the pelvis to support the weakened tissues. There is a lot of research going on to find the most suitable type of mesh to repair vaginal prolapse. The GYNECARE PROLIFT + M* Pelvic Floor Repair system is similar to a mesh already used for this procedure called ULTRAPRO*, but is lighter in weight. Currently, ULTRAPRO* is only approved for use in hernia repair and is not licensed for gynecological procedures. This study will be the first clinical investigation of this mesh in vaginal prolapse.
71 studies on the registry are indexed under Cystocele; 5 are open to participants now.
This study's enrollment of 126 is below the median of 292 across 23 observational studies indexed under Cystocele.
Browse Cystocele studies →Ethicon, Inc. is the lead sponsor of 66 studies on the registry; 2 are open to participants now.
Of its 11 completed or terminated interventional studies of FDA-regulated products, 10 (91%) have results posted.
Counted across the registry records on this site, refreshed daily.
Women over 18 with symptomatic pelvic organ prolapse of ICS POP-Q Stage III or IV, suitable for surgical repair.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GYNECARE PROLIFT+M\* Pelvic Floor Repair System
Device: GYNECARE PROLIFT+M* Pelvic Floor Repair System
Pre-shaped mesh implants made of GYNECARE GYNEMESH M composite mesh, comprised of absorbable polyglecaprone 25 monofilament fiber and nonabsorbable polypropylene monofilament fiber
Also known as: ULTRAPRO* mesh
Pelvic Organ Prolapse Quantification (POP-Q) score
Time frame: 12 months post-procedure
Summary of treated compartment ICS POP-Q stage
Time frame: 3, 12, 24 and 36 months
Proportion of subjects with the leading edge within the hymen and without further re-intervention for POP
Time frame: 12, 24 and 36 months
Incidence of de novo prolapse (a post-operative prolapse)only in the untreated compartment, provided there was no pre-operative defect in that compartment
Time frame: Procedure to 36 months
Mean scores and change from baseline in PFDI-20 scores, including sub scores (POPDI, CRADI and UDI
Time frame: 3, 12, 24 and 36 months
Mean scores and change from baseline in PFIQ-7, including sub-scores (POPIQ, CRAIQ and UIQ).
Time frame: 3, 12, 24 and 36 months
Days to return to normal activities (walking, driving, work, household activities and sexual intercourse)
Time frame: 1, 3, and 12 months
Assessment of sexual function using PISQ-12 (mean scores and change from baseline) in subjects sexually active at baseline
Time frame: 12, 24 and 36 months
Incidence of new onset dyspareunia, resolution or continuance of pre-existing dyspareunia
Time frame: Baseline to 36 months
Adverse Events
Time frame: Procedure to 36 months
Determination of any exposures/erosions including location
Time frame: Procedure to 36 months
Summary of International Continence Society (ICS) Stages
Time frame: 3, 24, and 36 months
This study is completed, as verified in May 2014. You cannot join it, but the record below documents what was studied.
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