Effect Of Pelvic Floor Rehabilitation On Muscle Activity,Incontience, Sexual Function And Quality Of Life Among Postpartum Women
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 377
- 试验地点
- 1
- 主要终点
- To evaluate the effectiveness of newly designed vaginal rectal stimulator and sit on top pelvic floor stimulator on kegels exercise in improving PFM activity,incontinence,sexual dysfunction and quality of life in postpartum primiparous women.
研究概览
简要总结
This experimental study follows a comparative pre- and post-test design, focusing on primiparous women who had normal vaginal deliveries. The study will be conducted at the outpatient physiotherapy department of ACS Medical College and Hospital, Dr. M.G.R. Educational & Research Institute. A total of 80 participants will be included in the study, selected through block randomization using the lottery method. The participants will fall within the age group of 21 to 35 years, and the study duration will span 12 months. Each intervention will be administered for 40 minutes per day, four days a week, with adequate intervals between sessions.The participants will be divided into three groups. Group A will receive pelvic floor muscle rehabilitation using a newly designed vaginal rectal stimulator combined with Kegel’s exercises. The vaginal rectal stimulation sensor, an intracavity probe, will be used to stimulate the pelvic floor muscles with mild electric currents targeting the nerves. This therapy is known to address issues such as urinary incontinence, anal dysfunction, and sexual dysfunction. Group B participants will undergo stimulation using a sit-on-top pelvic floor stimulator, which is a non-intracavity method, along with Kegel’s exercises. Finally, Group C will receive interferential therapy in combination with Kegel’s exercises.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant, Investigator and Outcome Assessor Blinded
入排标准
- 年龄范围
- 21.00 Year(s) 至 35.00 Year(s)（—）
- 性别
- Female
入选标准
- •1.Primiparous Women: Women who have delivered their first child, either through vaginal delivery.
- •2.Normal vaginal delivery with episiotomy .
- •Postpartum Period: Participants should be within 6 weeks to 6 months postpartum, with PFM strength about moderate contraction(17.6-32.0 mmHg) using periniometer readings .
- •3.Pelvic Floor Dysfunction Symptoms: Women experiencing symptoms of pelvic floor dysfunction, such as urinary incontinence and sexual dysfunction.
- •4.Age Group: Women aged between 21 and 35 years.
排除标准
- •1.Cesarean section as a mode of delivery 2.Pre-existing Pelvic Floor Disorders: Women with diagnosed pelvic floor dysfunction prior to pregnancy (e.g., chronic incontinence or pelvic organ prolapsed).
- •3.Complicated Pregnancy or Delivery women who experienced severe obstetric complications, such as third- or fourth-degree perineal tears, severe postpartum hemorrhage, or emergency surgeries.
- •4.Medical Conditions Affecting Pelvic Floor Rehabilitation: Presence of conditions such as neurological disorders (e.g., multiple sclerosis, spinal cord injuries) or musculoskeletal disorders that impair pelvic floor function or exercise capability.
结局指标
主要结局
To evaluate the effectiveness of newly designed vaginal rectal stimulator and sit on top pelvic floor stimulator on kegels exercise in improving PFM activity,incontinence,sexual dysfunction and quality of life in postpartum primiparous women.
时间窗: To evaluate the effectiveness of newly designed vaginal rectal stimulator and sit on top pelvic floor stimulator on kegels exercise in improving PFM activity,incontinence,sexual dysfunction and quality of life in postpartum primiparous women. | for 8 weeks | the assessment will be done after 8 weeks .
for 8 weeks
时间窗: To evaluate the effectiveness of newly designed vaginal rectal stimulator and sit on top pelvic floor stimulator on kegels exercise in improving PFM activity,incontinence,sexual dysfunction and quality of life in postpartum primiparous women. | for 8 weeks | the assessment will be done after 8 weeks .
the assessment will be done after 8 weeks .
时间窗: To evaluate the effectiveness of newly designed vaginal rectal stimulator and sit on top pelvic floor stimulator on kegels exercise in improving PFM activity,incontinence,sexual dysfunction and quality of life in postpartum primiparous women. | for 8 weeks | the assessment will be done after 8 weeks .
次要结局
- To explore the anxiety & depression associated with pelvis floor dysfunction.(posttest values will be assessed after 8 weeks .)
研究者
DEEPTHI RNV
Dr. M.G.R. Educational and Research Institute