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Clinical Trials/NCT01396122
NCT01396122UnknownNot Applicable

A Prospective, Multicenter Study to Evaluate the Clinical Performance of the GYNECARE PROSIMA* Pelvic Floor Repair System as a Procedure for Symptomatic POP-Q Stage II-III Pelvic Organ Prolapse

Peking Union Medical College Hospital30 sites in 1 country150 target enrollmentStarted: March 2011Last updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Enrollment
150
Locations
30
Primary Endpoint
Anatomical improvement according to POP-Q score.
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

The purpose of this study is to evaluate the safety and effectiveness of the GYNECARE PROSIMA* Pelvic Floor Repair System as a Device in Women with Symptomatic Pelvic Organ Prolapse.

Detailed Description

The GYNECARE PROSIMA* system is a new technique and now available in China. It provides a simplified unanchored mesh repair, making surgery much simpler to perform and reduces the risk of the specific complications that may occur when tunneling devices beyond the pelvic cavity.

In clinical practice, many women have symptomatic prolapse, which requires surgical correction. They are relatively young, and therefore care more about the long-term outcomes and quality of life after procedure. The purpose of this multicenter and prospective study is to evaluate the effectiveness and safety of the GYNECARE PROSIMA* system in the treatment of symptomatic POP-Q Stage II-III pelvic organ prolapse.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
Female
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •Candidates with symptomatic pelvic organ prolapse of ICS POP-Q Stage II or III, suitable for surgical repair. Vaginal hysterectomy and 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 approved informed consent.

Exclusion Criteria

  • •Additional surgical intervention concurrent to the 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.
  • •History of chemotherapy or pelvic radiation therapy.
  • •Systemic disease known to affect bladder or bowel function (e.g. Parkinson's disease, multiple sclerosis, 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.
  • •Chronic cough not well-controlled.
  • •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.

Outcomes

Primary Outcomes

Anatomical improvement according to POP-Q score.

Time Frame: 3 years

Secondary Outcomes

  • Pain score measured using Visual Analog Scale (VAS).(24 hours after surgery and postoperation visit at the 3-4 weeks.)
  • Hospital data including operative time, estimated blood loss, length of stay, maximum temperature, time of voiding recovery.(At discharge, an expected average of 5 days after operation.)
  • Discomfort of balloon removal, measured using VAS at time of removal.(24 hours after surgery.)
  • Subject discomfort of VSD by VAS.(postoperation visit at 3-4 weeks.)
  • Presence/absence of complications (composite score)(Up to 3 years.)
  • Change from baseline in PFIQ-7 scores.(6 months, 12 months, 2 years and 3 years.)
  • In subjects sexually active at baseline, assessment of sexual function using PISQ-12 (mean scores and change from baseline).(6 months, 12 months, 2 years and 3 years.)
  • Subject global impression assessed on a 5 point Likert scale.(6 months, 12 months, 2 years and 3 years.)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (30)

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