ProViS (Prolift+M and Vita Sexualis) Study (ProViS)
2013年11月25日 更新者：Dr. med. Tanja Hülder
ProViS (Prolift+M TM and Vita Sexualis) Study
Transvaginal meshes (TVM) are indicated for the treatment of pelvic organ prolapse (POP) where surgical intervention is necessary.
Due to a potential risk of de novo dyspareunia, TVM are mainly used in postmenopausal women and in case of recurrent POP.
PROLIFT+M (Trademark) is based on a highly flexible material which is partially absorbable.
We suggest that PROLIFT+M has less impact on the vita sexualis than conventional TVM and could also be used for the treatment of younger and/or sexually active women.
This study observes women who are routinely treated with PROLIFT+M with regard to their sexual function before and after the surgery.
The hypothesis is that there is no worsening in vita sexualis with PROLIFT+M.
研究概览
地位
完全的
条件
研究类型
观察性的
注册 (实际的)
18
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 及以上 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
女性
取样方法
非概率样本
研究人群
Patients visiting specialist in hospitals and specialized doctor's offices scheduled to undergo Prolapse surgery.
描述
Inclusion Criteria:
- The patient understands the nature and content of the trial
- POP ≥ stage II (according to the POP-Q system (18))
- Sexual intercourse ≥ 2x/4 weeks
- Written informed consent
- Negative pregnancy test in women of childbearing potential
- Women ≥ 18 years
Exclusion Criteria:
- Concomitant surgery at the inner genitalis (e.g. colporrhaphy, sacrocolpopexy, sacrospinous fixation, hysterectomy); concomitant suburethral slings and bulking agents are allowed
- Unable to read or speak German
- Women < 18 years
- Women who are pregnant or breastfeeding or planning future pregnancies
- Acute infection(s), e.g. untreated urogenital infections
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
队列和干预
团体/队列 |
|---|
|
PROLIFT+M
Patients that undergo surgery due to prolapse POP ≥ stage II with PROLIFT+M device having had ≥ 2x/4 weeks sexual intercourse before surgery.
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
vita sexualis
大体时间：7 to 1 day Preoperative vs. 12 months (+/- 1 month) Postoperative
|
No worsening in vita sexualis (decrease in total score Female Sexual Function Index (FSFI-d) of ≤ 3.3; max.
score = 36) measured at 12 months (+/- 1 month) postoperatively as compared to the preoperative score.
|
7 to 1 day Preoperative vs. 12 months (+/- 1 month) Postoperative
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
pain during sexual intercourse
大体时间：7 to 1 day Preoperative vs. 12 months (+/- 1 month) Postoperative
|
No worsening in pain during sexual intercourse (decrease in weighted pain subscore FSFI-d of ≤ 1; max score = 6) measured at 12 months (+/- 1 month) postoperatively compared to preoperative.
|
7 to 1 day Preoperative vs. 12 months (+/- 1 month) Postoperative
|
|
Assessment of pelvic floor function
大体时间：7 to 1 day Preoperative vs. 12 months (+/- 1 month) Postoperative
|
Assessment of pelvic floor function using the validated German pelvic floor questionnaire at 12 months (+/- 1 month) postoperatively compared to preoperative (Deutscher Beckenboden-Fragebogen, validated German Version of the Australian Pelvic Floor Questionnaire
|
7 to 1 day Preoperative vs. 12 months (+/- 1 month) Postoperative
|
|
Assessment of patient satisfaction
大体时间：12 months (+/- 1 month) Postoperative
|
Assessment of patient satisfaction at 12 months (+/- 1 month) postoperatively using the visual analogue scale (VAS), question regarding reoperation and patient global (PGI) question.VAS: On top of two scales, the question "How satisfied are you with the result of your operation?" is placed.
(Facial expressions are put above the line to express satisfaction visually).
In addition, the following two questions are asked: "Would you have the operation done again?" and "In the past 12 months how would you rate your condition as opposed to before your recent pelvic floor operation: much better/a little better/about the same/a little worse/much worse" (PGI question).
|
12 months (+/- 1 month) Postoperative
|
|
Assessment of recurrent POP (POP-Q ≥ stage II)
大体时间：3 months (12 weeks +/- 2) and 12 months (+/- 1 month) postoperatively
|
Assessment of recurrent POP (POP-Q ≥ stage II in the operated compartment(s)), mesh erosion/exposure; each measured 3 (12 +/- 2 weeks) and 12 months (+/- 1 month) postoperatively by clinical examination (Speculum, palpation, POP-Q)
|
3 months (12 weeks +/- 2) and 12 months (+/- 1 month) postoperatively
|
|
Safety
大体时间：until 12 months (+/- 1 month) postoperatively
|
Safety (documentation and assessment of medical device incidents; serious incidents and near incidents will be reported to the competent authorities)
|
until 12 months (+/- 1 month) postoperatively
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 学习椅：Tanja Hülder, Dr.med.、Cantonal Hospital of St. Gallen
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2011年5月1日
初级完成 (实际的)
2013年4月1日
研究完成 (实际的)
2013年10月1日
研究注册日期
首次提交
2013年10月29日
首先提交符合 QC 标准的
2013年11月25日
首次发布 (估计)
2013年11月28日
研究记录更新
最后更新发布 (估计)
2013年11月28日
上次提交的符合 QC 标准的更新
2013年11月25日
最后验证
2013年11月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.