The Effect of Pelvic Floor Muscle Exercises on Sexual Life in Women With Overactive Bladder
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- pelvic floor muscle contraction strength
研究概览
简要总结
This is a randomized controlled experimental study to determine the effect of pelvic floor muscle exercise on sexual life.
The study included 64 women admitted to the Erzurum City Hospital, who consented to participate. They were divided into intervention ond control groups (n=32). Pelvic Floor Muscle Exercise *PFME* was applied to the intervention group for 6 weeks with the Simplex Device accompanied by biofeedback in accordance with the PFME application procedure. The control group received routine care.
详细描述
This is a randomized controlled experimental study . The research was carried out in the Erzurum City Hospital. This study, which was conducted to examine the effect of pelvic floor muscle exercises *PFME* on sexual life in women with overactive bladder *OAB* , was conducted with 64 women (32 women: control group, 32 women: intervention group) who applied to the Erzurum City Hospital Urology Polyclinic between December 1, 2021 and December 1, 2024.
Research Hypotheses:
H1: Overactive bladder symptoms are positively affected in women with OAB who perform pelvic floor exercises.
H2: Sexual function is positively affected in women with OAB who perform pelvic floor exercises.
H3: Depression symptoms are positively affected in women with OAB who perform pelvic floor exercises.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Being between 18 and 70 years of age
- •Speaking Turkish
- •Being literate
- •Having a diagnosis of Overactive Bladder (OAB)
- •Currently receiving pharmacological treatment for OAB
- •Being willing to participate in the study voluntarily
排除标准
- •Presence of perceptual impairments or psychiatric disorders that interfere with communication
- •Diagnosis of a neurological disease
- •Presence of neuropathy due to Diabetes Mellitus
- •Pelvic organ prolapse at Stage 2 or higher
- •History of anti-incontinence surgery
- •Being pregnant
研究组 & 干预措施
Control
Women in the control group did not receive any intervention or pelvic floor muscle exercise training.
Intervention
The intervention group performed a pelvic floor muscle exercise program in addition to the pharmacological treatment routinely provided at the hospital. Pelvic Floor Muscle Exercise Program Week 1: Contract the pelvic floor muscles for 6 seconds, then relax for 6 seconds. Repeat 25 times. Perform 3 sessions per day (total of 75 contractions per day). Week 2: Contract for 6 seconds, relax for 6 seconds. Repeat 50 times. Perform 3 sessions per day (total of 150 contractions per day). Week 3: Contract for 6 seconds, relax for 6 seconds. Repeat 75 times. Perform 3 sessions per day (total of 225 contractions per day). Weeks 4-24: Contract for 6 seconds, relax for 6 seconds. Repeat 100 times. Perform 3 sessions per day (total of 300 contractions per day). After Week 24: Contract for 6 seconds, relax for 6 seconds. Repeat 50 times. Perform 3 sessions per day (total of 150 contractions per day).
干预措施: Exercise (Behavioral)
结局指标
主要结局
pelvic floor muscle contraction strength
时间窗: Change from beginning of the study and after 6th week of exercise program
Pelvic floor muscle strength measurement by digital palpation
pelvic floor muscle relaxation strength
时间窗: Change from beginning of the study and after 6th week of exercise program
Pelvic floor muscle strength measurement by Simplex device
Over active bladder questionnaire
时间窗: Change from beginning of the study and after 6th week of exercise program
This questionnaires evaluates urination frequency, sudden feeling of urgency, nocturia, urge type incontinence symptoms. It consists of 8 questions that patients can rate the severity of their complaints as none (0); very little (1); a little (2); quite a bit (3); a lot (4); and very much (5).
Female Sexual Function Index Scores ≤ 26.55
时间窗: Change from beginning of the study and after 6th week of exercises program
The Female Sexual Function Index consists of 19 items that measure six domains of female sexual function: Desire (2 items) Arousal (4 items) Lubrication (4 items) Orgasm (3 items) Satisfaction (3 items) Pain (3 items; includes discomfort during or after vaginal penetration) Each item is scored on a Likert-type scale, typically ranging from 0 or 1 to 5.Total score range: 2.0 to 36.0 Cut-off score: A total FSFI score of ≤26.55 is commonly used to indicate female sexual dysfunction (FSD).
Center of Epidemiologic Studies Depression Scale
时间窗: Change from beginning of the study and after 6th week of exercise program.
The Center of Epidemiologic Studies Depression Scale is designed to assess the frequency and severity of symptoms associated with depression. The original CES-D contains 20 items.Each item is scored on a 4-point Likert scale: 0 = Rarely or none of the time (\<1 day) 1. = Some or a little of the time (1-2 days) 2. = Occasionally or a moderate amount of time (3-4 days) 3. = Most or all of the time (5-7 days) Total scores range from 0 to 60. A score of 16 or higher is generally used as a cut-off to indicate significant levels of depressive symptoms, though this is not a diagnostic tool.
次要结局
未报告次要终点
研究者
Nezihe KIZILKAYA BEJI
Professor
Biruni University