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U.S. Department of Health and Human Services

522 Postmarket Surveillance Studies

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AE and Effectiveness Rates

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Study Status Completed
522 Number / Requirement Number PS130015 / PSS001
Date Current Plan Accepted 04/25/2014
Study Name AE and Effectiveness Rates
Root Document Number K063136 
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source New Data Collection
Comparison Group Concurrent Control
Analysis Type Analytical
Study Population Adult: >21
Detailed Study Protocol Parameters
Study Design Description The manufacturer used data from a published study to fulfill the postmarket surveillance (522) order. The study was a two arm prospective study that compared the safety and effectiveness outcomes of patients who were treated with Contasure Needleless sling and transobturator-TVT for stress urinary incontinence.

Study Population Description All patients affected by urodynamic Stress Urinary Continence (SUI) and a positive stress test, with or without associated genital prolapse, and treated with either Contasure Needleless Sling (treatment arm) or Gynecare TVT obturator system (comparison arm).

Sample Size 143 patients in the treatment arm and 114 patients in the comparison arm

Data Collection Comparison of objective cure (Stress test-presence of a negative stress test) and subjective cure (patients¿ subjective impression measured by Sandvik Severity Index) rates between 2 groups (non-inferiority testing). 2. Comparison of adverse events such as organ perforation, bleeding (including hemorrhage and hematoma), mesh exposure in the vagina, mesh erosion into the bladder, pelvic pain, infection, de novo dyspareunia, urinary retention, recurrent incontinence, other urinary problems, neuro- muscular problems, revision/resurgery. 3. Comparison of quality of Life measured by International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF)

Follow-up Visits and Length of Follow-up Baseline, 6 months, 12 months, 24 months and 36 months. Length of follow-up is 36 months

Interim or Final Data Summary
Actual Number of Patients Enrolled 143 patients in the treatment arm and 114 patients in the comparison arm

Actual Number of Sites Enrolled 1

Patient Followup Rate 92% in the treatment arm and 95% in the comparison arm
Final Safety Findings The most common adverse events are de novo urge incontinence (ranged from 8.3% to 11.7% in the Contasure Needleless sling group through 36 months and from 13.0% to 15.8% in the TVT-o group) and recurrent incontinence (ranged from 13.6% to 15.6% in the Contasure Needleless sling group through 36 months and from 5.9% to 12.0% in the TVT-o group) for both groups. Of note, mesh erosion in the bladder was not observed in either group, and mesh exposure in vagina The following adverse events were not observed in either group through 36 months: Mesh erosion in the bladder, other pains, de novo dyspareunia, infection, other urinary problems and neuromuscular problems. According to the non-inferiority test results, Contasure Needleless sling is non-inferior to TVT-o for each adverse events at each time point, with the exception of recurrent incontinence at 6 months.

Final Effectiveness Findings The primary effectiveness endpoint of the study is ¿negative cough stress test¿. It was reported that 112 patients out of 130 in the Contasure and 95 patients out of 108 in the TVT-o group had negative cough test at 36 months. The results suggested that Contasure Needleless sling success rates are non-inferior to the comparator group at 12, 18 (imputed), 24 and 36 months, but not at 6 months. Regarding quality of life, both groups showed a statistically significant improvement in quality of life scores at the end of the study (at 36 months, ICIQ score improved from 5.64 (baseline) to 0.86 in the treatment arm and from 5.66 (baseline) to 0.80).

Study Strengths and Weaknesses The strength of the study is being a prospective study with a comparison arm and high follow-up rate. The weakness of the study is being a non-randomized study and lack of blinding.
Recommendations for Labeling Changes No labeling update. The study results on the long term data have been published (Franco EM and Tardiu LA. Contasure-Needleless single incision sling compared with transobturator TVT-O for the treatment of stress urinary incontinence: long-term results. Int Urogynecol J: 17 July 2014: published online)

AE and Effectiveness Rates Schedule

Report Schedule
Date Due
FDA Receipt
Applicant's Reporting Status
Final report 05/31/2014 06/11/2014 Overdue/Received

  • The 522 Postmarket Surveillance Studies Program encompasses design, tracking, oversight, and review responsibilities for studies mandated under section 522 of the Federal Food, Drug and Cosmetic Act. The program helps ensure that well-designed 522 postmarket surveillance (PS) studies are conducted effectively and efficiently and in the least burdensome manner.
  • In May 2008, the oversight responsibility of the 522 Postmarket Surveillance Studies Program was transferred to the Division of Epidemiology (DEPI) of the Office of Surveillance and Biometrics (OSB)/Center for Devices and Radiological Health (CDRH). DEPI continues to build the 522 program.
  • CDRH has established an automated internal tracking system that efficiently identifies the reporting status of active 522 PS studies based on study timelines incorporated in study protocols and agreed upon by the CDRH and applicants. This system represents CDRH's effort to ensure that all 522 PS commitments are fulfilled in a timely manner.
  • In addition, CDRH launched this publicly available webpage to keep all stakeholders informed of the progress of each 522 PS study. The webpage displays general information regarding each study, as well as the overall study status (based on protocol-driven timelines and adequacy of the data) and the applicant's reporting status for each submission due.


Contact Information

Cheryl Reynolds
Project Manager, 522 Postmarket Surveillance (PS) Studies Program
Food and Drug Administration
10903 New Hampshire Ave
Silver Spring, MD 20993-0002

Phone: (301) 796-6068
Fax: (301) 847-8140