Axis™ Allograft Dermis for Female Pelvic Floor Repair: a Prospective Post Market Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 74
- 试验地点
- 5
- 主要终点
- Percentage of Participants With POP-Q Stage Improvement Assessed by POP-Q Stage Improvement Based Upon Grading of Prolapse of the Anterior, Posterior, or Combined Anterior and Posterior Compartments Compared Between Baseline and One Year.
研究概览
简要总结
This study is a prospective, single arm, multi-center, post-market study to evaluate the efficacy of Axis™ Allograft Dermis used for anterior, posterior or combined (anterior and posterior) pelvic organ prolapse repair.
详细描述
The study population will be adult female patients with pelvic organ prolapse, POP-Q Stage ≥ 2 that are clinically indicated for surgical intervention with Axis Allograft Dermis in the anterior, posterior or combined (anterior and posterior) compartments.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Adult female at least 18 years of age.
- •Willing and able to provide written informed consent.
- •Confirmed pelvic organ prolapse (POP) of Stage 2 or higher as determined by POP-Q prolapse grading requiring surgical intervention in the anterior, posterior or combined (anterior and posterior) compartment.
- •Willing and able to complete all follow-up visits and procedures indicated in this protocol.
排除标准
- •Concurrent surgical treatment of pelvic organ prolapse using anything other than the Axis Dermis.[Note: concurrent mid-urethral sling placement for treatment of stress urinary incontinence is allowed].
- •Confirmed Stage 2 or higher prolapse as determined by POP-Q prolapse grading for a compartment that is not being repaired in the same procedure. (Concurrent POP-Q Stage 1 repair is at the physician's discretion.)
- •Previous pelvic organ prolapse repair using biologic, or synthetic grafts. [Note: previous mid-urethral sling for treatment of stress urinary incontinence is allowed]
- •Pregnant or a desire to become pregnant in the future.
- •Previous radiation or other treatments for cancer in the pelvic area.
- •Severe urogenital atrophy.
- •Immunosuppression and/or current systemic steroid user.
- •Any contraindication to the surgical procedure.
结局指标
主要结局
Percentage of Participants With POP-Q Stage Improvement Assessed by POP-Q Stage Improvement Based Upon Grading of Prolapse of the Anterior, Posterior, or Combined Anterior and Posterior Compartments Compared Between Baseline and One Year.
时间窗: 1 year
The Pelvic Organ Prolapse Quantification system (POP-Q) is used to measure pelvic organ prolapse. POP-Q Stages are: Stage 0: No prolapse is demonstrated Stage 1: The criteria for stage 0 are not met, but the most distal portion of the prolapse is greater than 1 cm above the level of the hymen Stage 2: The most distal portion of the prolapse is greater than or equal to 1 centimeter proximal to or distal to the plane of the hymen Stage 3: The most distal portion of the prolapse is greater than 1 centimeter below the plan of the hymen but protrudes no further than 2 centimeters less that the total vaginal length in centimeters Stage 4: The distal portion of the prolapse protrudes to at least (TVL-2) centimeters. Improvement at one year is categorized as follows: Cured: Pop-Q Stage reduced to 0 or 1, or improved by 2 stages from baseline Improved: POP-Q Stage \> 1, but improved by 1 stage from baseline Failed: POP-Q Stage stayed the same or increased in severity from baseline
次要结局
- Percentage of Participants With POP-Q Stage Improvement Assessed by POP-Q Stage Improvement Based Upon Grading of Prolapse of the Anterior, Posterior, or Combined Anterior and Posterior Compartments Compared Between Baseline at 24 Months(24 months)
- Change in Patient Sexual Satisfaction From Baseline After Pelvic Organ Prolapse Repair With Axis Allograft Dermis Measured by Participant Pelvic Organ Prolapse/Urinary Incontinence Sexual Function Questionnaire (PISQ-12) at 12 Months(Baseline and 12 months)
- Change in Participant Sexual Satisfaction From Baseline After Pelvic Organ Prolapse Repair With Axis Allograft Dermis Measured by Participant Pelvic Organ Prolapse/Urinary Incontinence Sexual Function Questionnaire (PISQ-12) at 6 Months(Baseline and 6 months)
- Change in Patient Sexual Satisfaction From Baseline After Pelvic Organ Prolapse Repair With Axis Allograft Dermis Measured by Participant Pelvic Organ Prolapse/Urinary Incontinence Sexual Function Questionnaire (PISQ-12) at 24 Months(Baseline and 24 months)
- Percentage of Participants With POP-Q Stage Improvement Assessed by POP-Q Stage Improvement Based Upon Grading of Prolapse of the Anterior, Posterior, or Combined Anterior and Posterior Compartments Compared Between Baseline and Six Weeks(6 weeks)
- Percentage of Participants With POP-Q Stage Improvement After POP Repair With Axis Assessed by POP-Q Stage Improvement Based Upon Prolapse Grading of the Anterior, Posterior, or Combined Anterior and Posterior Compartments Between Baseline and Six Months(6 months)
- Percentage of Participants With POP-Q Stage Improvement After POP Repair With Axis Assessed by POP-Q Stage Improvement Based Upon Prolapse Grading of the Anterior, Posterior, or Combined Anterior and Posterior Compartments Between Baseline at 36 Months(36 months)
- Change in Pelvic/Bladder Pain With Sexual Activity Visual Analog Scale (VAS) Questionnaire From Baseline to 6 Weeks, 6 Months, 12 Months, 24 Months, 36 Months(Baseline and 6 weeks, 6 months, 1 year, 2 years, 3 years)
- Percentage of Participants Who Had Surgical Revision of the Index Prolapse Compartment(s) After Pelvic Organ Prolapse Repair With Axis(3 year)
- Percentage of Participants Responding "Very Much Better" or "Much Better" on Patient Global Impression of Improvement for Urogenital Prolapse (PGI-I) at 24 Months(24 month)
- Change in Patient Sexual Satisfaction From Baseline After Pelvic Organ Prolapse Repair With Axis Allograft Dermis Measured by Participant Pelvic Organ Prolapse/Urinary Incontinence Sexual Function Questionnaire (PISQ-12) at 36 Months(Baseline and 36 months)
- Percentage of Participants Responding "Very Much Better" or "Much Better" on Patient Global Impression of Improvement for Urogenital Prolapse (PGI-I) at 12 Months(12 months)
- Ratings for the Validated Surgical Satisfaction Questionnaire (SSQ-8) in Women Following Surgery to Correct Pelvic Organ Prolapse Repair With Axis Allograft Dermis at the 6 Week, 6 Month, 12 Month, 24 Month, and 36 Month Visits.(6 week, 6 month, 12 month, 24 month, and 36 month visits)
- Change in the Participants Response on the Pelvic Floor Impact Questionnaire (PFIQ) From Baseline to 6 Weeks, 6 Months, 12 Months, 24 Months, 36 Months(Baseline and 6 weeks, 6 months, 12 Months, 24 Months, 36 Months)
- Percentage of Participants Responding "Very Much Better" or "Much Better" on Patient Global Impression of Improvement for Urogenital Prolapse (PGI-I) at 36 Months(36 months)
- Change in Pelvic/Bladder Pain With Daily Activity Visual Analog Scale (VAS) Questionnaire From Baseline to 6 Weeks, 6 Months, 12 Months, 24 Months, 36 Months(Baseline and 6 weeks, 6 months, 12 months, 24 months, 36 months)
- Change in Pelvic Floor Distress Inventory (PFDI-20) Questionnaire After Pelvic Organ Prolapse Repair With Axis Allograft Dermis From Baseline to 6 Weeks, 6 Months, 12 Months, 24 Months, and 36 Months(Baseline and 6 weeks, 6 months, 12 Months, 24 Months, 36 Months)