Effectiveness and Safety of Non-ablative Radiofrequency in the Treatment of Pelvic Organ Prolapse and Its Associated Symptoms
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 40
- 主要终点
- Change in degree of prolapse
研究概览
简要总结
Aim To compare the effectiveness of the application of non-ablative radiofrequency (RF) applied in combination with the usual treatment for the treatment of pelvic organ prolapse (POP) versus the usual treatment in lowering its severity.
The secondary objective is to compare the effectiveness of both interventions in the symptoms most commonly associated with POP (pelvic heaviness, bulging, and prolapse-related lumbar pain).
Design Randomized, double-blind clinical trial. Women between 18 and 75 years old with symptoms of vaginal prolapse, defined as "sensation of mass or lump" and / or "sensation of dragging in the vagina", and who also have the presence of POP diagnosed under clinical criteria and quantified using simplified POP-Q assessment.
All women with asymptomatic vaginal prolapse grade IV or less than GI of the cervix or less than or equal to GI of the anterior and / or posterior vaginal Wall (asymptomatic); presence of more than one vaginal prolapse, and also those women with chronic connective tissue diseases or who present some type of contraindication to the application of RF therapy, will be excluded from the study Methods The study will include 20 women in the intervention group and 20 women in the control group.
The women will be recruited from the patients who attend the Ketty Ruiz Pelviperineal Physiotherapy Clinic, which it´s specialized in treating pelvic floor dysfunctions.
Interventions The usual intervention will be applied to both groups of the study. It will consist of supervised individualized sessions (up to a maximum of 8 sessions) by physiotherapists who are part of the research team. They will include the application of exercises to balance the pelvis and the muscles related to it, treatment of the trigger points detected through the application of manual and / or instrumental techniques, teaching of the activation of the transverse abdominis with ultrasound biofeedback and teaching of reflex activation exercises of the transverse abdominis and pelvic floor muscles in different body positions.
The RF will be administered during the exercises of reflex activation of transversus abdominis and pelvic floor muscles on a stretcher (supine position). It will be applied intracavitary, in monopolar application, reaching a temperature between 42-45ºC in the tissues (according to the patient's tolerance), and with a power of 50% until the desired temperature is reached. It will be applied with a frequency that will be individualized according to the maximum level of energy absorption by the patient's tissues (between 0.8-1.2MHz) and with a dose of approximately between 3-4 KJ depending on the application time (20 minutes / session). In addition, they will be applied 1 session per week. The treatment will last 8 weeks.
The application of RF in the control group will follow the same application procedure as in the intervention group, but in this case, no type of parameter is applied to the RF device, ie, the device remains off for the entire duration of the session.
Variables:
For the measurement of the main variable of the study, the simplified POP-Q will be used, considered the "gold standard" for the classification of POP. To measure the secondary variables of the study, the Pelvic Organ Prolapse Symptom Score (POP-SS) questionnaire will be used to assess the symptoms of pelvic bulging and / or heaviness; a visual analog scale (VAS) for the intensity of lumbar pain related to prolapse, the Prolapse Quality of Life (P-QOL) questionnaire for measuring the quality of life related to vaginal prolapse and finally structured interviews will be conducted with all study subjects throughout the duration of the study to assess the safety of the intervention The immediate effect (ie, at the end of the 1st treatment session) in the quantitative assessment of prolapse and the short-term effects (i.e. 1 week after the last face-to-face treatment session) and medium (at 3 and 6 months after end of treatment) and long-term effects (at 12 months after finishing treatment) in all study variables will be evaluated.
Statistical analysis and ethical aspects It will be carried out using the SPSS 25.0 statistical package. This project is in process of being approved by the Research Ethics Committee (CEI) of the Balearic Islands (IB 4459/21 PS).
详细描述
Effectiveness and safety of non-ablative radiofrequency in the treatment of pelvic organ prolapse and its associated symptoms OBJECTIVES Primary To compare the effectiveness of application of non-ablative radiofrequency applied in combination with the usual treatment versus usual treatment for the treatment of pelvic organ prolapse (POP) - specifically in the reduction of vaginal prolapses.
Secondary To compare the effectiveness of both interventions in the symptoms most commonly associated with vaginal prolapse (pelvic heaviness, bulging, and POP-related low back pain).
Specific
- To analyze the prevalence of symptoms associated with vaginal prolapse depending on the stage of POP.
- Compare the effectiveness depending on the location of prolapse: anterior vaginal wall, posterior vaginal wall or vaginal vault.
- Compare the effectiveness according to the degree of prolapse (stages extracted from the simplified POP-Q: I, IIA, IIB and III).
- Compare the effectiveness based on age.
- Evaluate the relationship of vaginal prolapse symptoms with the location and severity of vaginal prolapse, respectively in the anterior, posterior and apex wall (Ba, Bp and C).
- Evaluate the immediate effect of RF application on the stage of prolapse.
- Estimate the effect of both interventions (usual treatment vs usual treatment with active RF), at the end of the 1st treatment session and after finishing the treatment: short (1 week after the last session), medium (at 3 and 6 months post-intervention) and long-term (at 12 months post-intervention) on the quantitative assessment of POP and the most commonly associated symptoms.
- Evaluate the safety of the RF technique (presence of adverse events)
METHODOLOGY DESIGN Double-blind clinical trial with two interventions: usual treatment for POP versus the usual treatment including application of RF. These interventions are randomly assigned. The full follow-up period is 12 months. The study design conforms to the recommendations of the Consolidated Standards of Reporting Trials (CONSORT) for Statement to Randomized Trials of Nonpharmacological Treatment.
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
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
The women will be assigned to each of the study groups in an individualized random way, based on the table of random numbers generated prior to the start of the study through the EPIDAT v.4 software (Galicia, Spain). The randomization sequence will be kept hidden, through the use of sealed and opaque envelopes previously prepared by the main investigator of the project (JCFD) and which will be placed in a box available to the physiotherapists who perform each of the interventions.
The allocation of women to the treatment groups will be blinded and also the blinding will be maintained in the analysis (evaluation of results), in such a way that in the data analysis only the groups will be identified.
It is not possible to blind the physiotherapist professionals who perform the intervention (neither in the IG nor in the CG).
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women between 18 and 75 years old.
- •Women who state symptoms of vaginal prolapse, defined as "sensation of mass or lump" and / or "sensation of dragging in the vagina" and who also have the presence of POP; i.e. descent of one of the anterior, posterior or uterus vaginal walls (cervix) diagnosed under clinical criteria and quantified using the simplified POP-Q assessment system.
排除标准
- •Prolapse vaginal GIV (according to clinical stage evaluated by POP-Q -Pelvic Organ Prolapse Quantification-).
- •Presence of more than one POP
- •Asymptomatic vaginal prolapse grade IV or less than GI of the cervix or less than or equal to GI of the anterior and / or posterior vaginal Wall
- •Women with chronic connective tissue diseases
- •Women who present contraindication to the application of RF therapy such as: pregnancy, metallic prostheses within the electric field, decompensated arteriopathies, malignant neoplasms, active infectious processes, pacemakers, loss of thermal sensitivity,….
- •Revocation of informed consent
结局指标
主要结局
Change in degree of prolapse
时间窗: Change from baseline degree of prolapse at the end of the first treatment session, at 9th week and at 3rd, 6th and 12th months, post treatment
Quantitative description of the position of the pelvic organs through simplified POP-Q
次要结局
- Changes in prolapse symptoms: bulging, pelvic heaviness and low back pain - related to POP-(Change from baseline in prolapse symptoms at 9 weeks and 3, 6 and 12 months post treatment)
- Changes in quality of life(Change from baseline in prolapse symptoms at 9 weeks and 3, 6 and 12 months post treatment)
- Satisfaction with treatment(12 months post treatment)
研究者
Juan Carlos Fernández Domínguez
PhD
Fundació d'investigació Sanitària de les Illes Balears