Randomised, Sham Controlled Trial of Fotona Smooth Erbium Yag Laser In the Treatment of Pelvic Organ Prolapse.
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 入组人数
- 25
- 主要终点
- Pelvic Organ Prolapse Quantification Score (POP-Q) between baseline and 12 months after treatment.
研究概览
简要总结
Patients seen with Stage 1-2 pelvic organ prolapse (POP) who have failed conservative treatments will be offered to participate in a sham controlled RCT of outpatient therapy with the Fotona Smooth Erbium Yag Laser. Patients will be randomised to either outpatient laser treatments or sham treatments. Patients will be blinded to which arm they have been randomised. Patients will be asked to complete appropriate relevant symptom and quality of life questionnaires and prolapse scoring, prior to treatment and at each monthly treatment and then 6 and 12 months following the final treatment. At 6 months following final treatment, Sham patients will be un-blinded and offered the laser therapy if they wish.
详细描述
All patients with symptomatic stage 1-2 POP, who have failed / declined conservative therapy will be informed about the study and invited to participate.
Once eligibility for inclusion into the study has been confirmed and written consent has been obtained, the patient will be invited for a baseline visit. At this visit the patient will have their medical history confirmed and have all Pelvic Organ Prolapse Quantification Score (PoP-Q) measurements made. They will be given the ICIQ Vaginal Symptom (ICIQ-VS) and Pelvic Organ Prolapse/Urinary Incontinence Sexual Function Questionnaire (PISQ-12) questionnaire.
Patients will be randomised and blinded to their allocated arm: active treatment or sham treatment (2:1, treatment : Sham).
Patients will then undergo 4 outpatient treatment visits. The timing of visits will be from 1 month apart. Before each treatment, they will have their urine tested for infection (dipstick urinalysis) and a pregnancy test (not required if had hysterectomy / sterilised). If urinalysis is negative, they will be receive an outpatient ProlapLase treatment which lasts 20 minutes. They will be given a leaflet outlining what to expect and a contact number if they have any concerns or questions. They will be asked about any deleterious effects since their last appointment, have a PoPQ score recorded and asked to complete a Patient Global Impression of Improvement (PGI-I) questionnaire. Patients will routinely receive 4 treatments. Each treatment will be 4 weeks apart.
Patients will be invited to attend a follow up visit 6 months after the 4th treatment. They will be asked if they are happy to continue to participate in the trial and if happy, asked to complete International Consultation on Incontinence Questionnaire (ICIQ-VS), Pelvic Organ Prolapse/Urinary Incontinence Sexual Function Questionnaire (PISQ-12) and Patient Global Impression of Improvement (PGI-I) symptom questionnaires and undergo a Pelvic Organ Prolapse Quantification Score (PoP-Q) score. Patients will be asked about any Adverse Event / Serious Adverse Event since involvement in the study. Patients randomised to the Sham arm will be un-blinded at 6 months and offered the treatments (x4) if they wish. They will then be followed up at 6 and 12 months after 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
- 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
- 否
入选标准
- 未提供
排除标准
- •Exclusion Criteria
- •Pre-existing bladder pathology including prior radiation treatment
- •Radical pelvic surgery or previous incontinence surgery
- •Urinary tract infection or other active infections of urinary tract or bladder
- •Any form of pelvic organ prolapse greater than stage 2, according to POP-Q
- •Diagnosis of collagen disorders eg.benign joint hypermobility / Elhers-Danlos / Marfans etc.
- •Incomplete bladder emptying
- •Vesicovaginal fistula
- •Faecal incontinence
- •Unwillingness or inability to complete follow-up schedule
- •Unwillingness or inability to give Informed Consent
- •Failure to comply with diary requirements during extended baseline period
结局指标
主要结局
Pelvic Organ Prolapse Quantification Score (POP-Q) between baseline and 12 months after treatment.
时间窗: 12 months
The change in Pelvic Organ Prolapse Quantification Score (PoP-Q) classification between baseline and 12 months, range = 0 - stage 4
Pelvic Organ Prolapse Quantification Score (POP-Q) between baseline and 6 months after treatment.
时间窗: 6 months
The change in Pelvic Organ Prolapse Quantification Score (PoP-Q)classification between baseline and 6 months, range = 0 - stage 4
次要结局
- Change in mean International Consultation on Incontinence Questionnaire - Vaginal Symptoms (ICIQ-VS) test scores from baseline to 12 months post treatment(12 months)
- Change in mean Pelvic Organ Prolapse/Urinary Incontinence Sexual Function Questionnaire (PISQ-12) scores(12 months)
- Patient's Global Impression of Improvement (PGI-I) at 6 months(6 months)
- Change in mean International Consultation on Incontinence Questionnaire - Vaginal Symptoms (ICIQ-VS) test scores from baseline to 6 months post treatment(6 months)
- Patient's Global Impression of Improvement (PGI-I) at 12 months(12 months)
- Pain visual analogue scale(4 months)