Perineorrhaphy Outcomes Related to Body Imagery (POETRY)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 51
- 试验地点
- 4
- 主要终点
- Body Image, by using the Body Image in Pelvic Organ Prolapse (BIPOP) questionnaire
研究概览
简要总结
The purpose of this study is to determine whether performing a perineorrhaphy during a reconstructive surgery indicated for pelvic organ prolapse (POP) affects a patient's body image.
详细描述
The objective of this study is to assess the body image of women before and after pelvic reconstructive surgery with and without perineorrhaphy to examine if a perineorrhaphy impacts postoperative body image by conducting a single-blind, randomized controlled clinical trial. The central hypothesis is that patients' body image will not be affected by whether or not a perineorrhaphy is performed.
The target population are those patients with POP who are planning an apical prolapse repair. All participants will give written consent prior to their surgery. After enrollment, women will fill out baseline surveys, including the Body Image in Pelvic Organ Prolapse (BIPOP), the Pelvic organ prolapse/Incontinence Sexual Questionnaire, IUGA-revised) (PISQ-IR), the Pelvic Floor Distress Inventory (PFDI-20), and a Pain Visual Analog Scale (VAS) to assess baseline pain. Additionally, participants will undergo a Pelvic Organ Prolapse Quantification (POP-Q) examination with the addition of measurements of genital hiatus (GH) and perineal body (PB) lengths without strain. The other measurements involved in the POP-Q entail assigning numerical values to descent of different parts of the vagina. Pelvic floor muscle strength will be measured using a Peritron™ perineometer and Kegel strength (contraction of the pelvic floor muscles) using the Oxford grading scale.
On the day of the patient's surgery, the surgeon will call a research coordinator who will open the next envelope in the sequence randomizing the patient to perinorrhaphy or to no perineorrhaphy. Randomization assignment will be generated by a computer-based randomization table and assigned by a research coordinator not otherwise involved in the study. Women will not be informed to what arm of the study they were randomized, and postoperative assessments will be made by individuals not involved with the patient's surgery.
At prescribed time points post-operatively, the patients will be assessed by POP-Q, genital hiatus and perineal body measurements performed with and without strain, the pain VAS, the BIPOP, The PISQ-IR, the PFDI-20, and pelvic floor muscle strength via the Oxford scale and measurement by the Peritron™ perineometer.
The investigators' aims for this study are:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
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
- •Subjects ≥ 18 years of age
- •Symptomatic POP who desire vaginal or abdominal apical suspension
- •English-speaking/reading
- •Genital hiatus measurement < 6 cm, >2cm
排除标准
- •Those who desire colpocleisis
- •Those whose surgical planning includes levatorplasty
- •Genital hiatus measurements greater than or equal to 6 cm, < 2 cm
- •Inability to speak/understand English
- •Those who specifically request a perineorrhaphy
- •Pregnant patients
研究组 & 干预措施
Perineorrhaphy
Patients who are randomized to receive a perineorrhaphy as part of their vaginal or abdominal reconstructive procedure
干预措施: Perineorrhaphy (Procedure)
No Perineorrhaphy
Patients who are randomized not to receive a perineorrhaphy as part of their vaginal or abdominal reconstructive procedure
干预措施: No Perineorrhaphy (Procedure)
结局指标
主要结局
Body Image, by using the Body Image in Pelvic Organ Prolapse (BIPOP) questionnaire
时间窗: 6 weeks post-operatively
To determine if a patient's body image, by using the Body Image in Pelvic Organ Prolapse (BIPOP) questionnaire, is affected by concomitant performance of a perineorrhaphy at the time of pelvic organ prolapse surgery.
次要结局
- Sexual Function, as measured by the validated questionnaire, PISQ-IR(3 months post-operatively)
- Post-operative Pain by using a pain visual analog scale(6 weeks post-operatively)
- Pelvic Floor Muscle Strength as measured by the Peritron™ perineometer and digitally.(6 weeks post-operatively)
- Pelvic Organ Prolapse Quantification (POP-Q) Measurements(Pre-operatively, in the operating room, 1 week, 6 weeks, and 3 months post-operatively)
研究者
Cara Ninivaggio
Urogynecology Fellow, University of New Mexico
University of New Mexico