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临床试验/NCT07145216
NCT07145216尚未招募不适用

Effect of Knack Pelvic Floor Contraction on Sexual Dysfunction in Females With Stress Urinary Incontinence

Cairo University1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2025年9月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
40
试验地点
1
主要终点
Assessment of pelvic floor muscle strength

研究概览

简要总结

This study aims to investigate the effect of knack pelvic floor contraction on sexual dysfunction in females with stress urinary incontinence.

详细描述

Stress urinary incontinence may have a tremendous effect on psychological and social well-being. Women with SUI report an inferior health-related quality of life (HRQOL) compared to continent women. Sexual well-being is an important aspect of women's health, and dysfunction can lead to a decrease in HRQOL and affect the marital relationship. It has been reported that women with UI also have problems with sexual activity. The presence of urinary leakage during intercourse can adversely affect sexual function.

Physiotherapy treatments for female SUI include PFMT such as knack maneuver, biofeedback, electrical stimulation, core stabilization, diet modifications, and behavioral therapy.

The knack is a simple, quick exercise technique that improves bladder control and increases PFM strength; it increases the urethral closure pressure, improves bladder stabilization and increases the structural support during PFM contraction. A previous study compared the knack effect on SUI using different methods like EMG biofeedback, verbal instructions, and vaginal palpation. It was found to have a positive impact on urinary symptoms, regardless of the teaching methods. Another previous study investigated the knack effect on vaginal laxity and found that it improved PFM contraction and sexual function and reduced vaginal laxity.

Up to now, no study has investigated the effect of the knack maneuver on female SUI associated with sexual problems, so this study will be the first one on this issue; therefore this study will be of valuable benefits and increase the knowledge of the physical therapist and health care provider in the women's health field.

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 (Outcomes Assessor)

入排标准

年龄范围
25 Years 至 45 Years(Adult)
性别
Female
接受健康志愿者
否

入选标准

  • •Females with mild and moderate degrees of SUI according to Incontinence Severity Index score (mild: 1-2; and moderate: 3-4 scoring).
  • •Their ages will range from 25 to 45 years old.
  • •Their body mass index (BMI) will be less than 30 kg/m
  • •They are multiparous women.
  • •Females complain of sexual disorders related to SUI, identified by an FSFI score of less than 28.1
  • •They have a sedentary lifestyle.

排除标准

  • •Severe degree of SUI.
  • •Other types of urinary incontinence, such as urge urinary incontinence and mixed urinary incontinence.
  • •Other neurological diseases such as myasthenia gravis and Parkinsonism.
  • •History of pelvic fractures.
  • •Menopausal women.
  • •Females with pelvic organ prolapse (POP).

研究组 & 干预措施

Interferential stimulation

Active Comparator

It will include 20 participants suffering from SUI associated with sexual dysfunction who will receive interferential stimulation for 20 minutes, 3 days per week for 8 weeks.

干预措施: Interfrential stimulation (Other)

Interferential stimulation + Knack pelvic floor exercise

Experimental

It will include 20 participants suffering from SUI with sexual dysfunction who will receive interferential stimulation for 20 minutes in addition to the knack maneuver for 15 minutes, 3 days per week for 8 weeks.

干预措施: Interfrential stimulation (Other)

Interferential stimulation + Knack pelvic floor exercise

Experimental

It will include 20 participants suffering from SUI with sexual dysfunction who will receive interferential stimulation for 20 minutes in addition to the knack maneuver for 15 minutes, 3 days per week for 8 weeks.

干预措施: Knack pelvic floor training (Other)

结局指标

主要结局

Assessment of pelvic floor muscle strength

时间窗: 8 weeks

PortablE biofeedback device will be used to assess pelvic floor muscle contraction. Each woman in both groups will be asked to count from 0 to 10 for 5 sets to achieve mental relaxation. Then, the area of the perineum will be cleaned with a disinfectant solution. The participant will insert the probe, which was covered with a condom and lubricated with hypoallergenic gel, into her vaginal cavity. The internal probe promotes proprioception and aids muscle awareness. The participants will be instructed to place the probe inside the vagina to a location where 0.5-1.0 cm of the probe is visible from the outside of the introitus. PFM strength will then be evaluated by a maximum voluntary contraction, as will be measured by squeeze pressure. Vaginal pressure testing will be performed with three repetitions of maximum voluntary contractions that each will be lasted for 3 s, with a 3-s rest between contractions. 2-minute rest break will then be taken, and the average score will be recorded.

Assessment of sexual function

时间窗: 8 weeks

The Arabic version of female sexual function Index score (FSFI) will be used to assess sexual function for all participating women in both groups before and after treatment program. All women in both groups will be asked to fill 5 domains of the questionnaire after explanation of them. The scoring system has a range of 2 to 36. According to Anis et al. (2011), a score above 28.1 indicated a good sexual life, whereas a score below 28.1 indicated reduced sexual function. The five categories of the questionnaire are severe (2-7.2), moderate (7.3-14.4), mild to moderate (14.5-21.6), mild (21.7-28.1 "cutoff point"), and no FSD (28.2-36)

次要结局

  • Assessment of symptoms of SUI(8 weeks)
  • Assessment of quality of life(8 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Wafaa Ibrahim Hussein

Principal investigator

Cairo University

研究点 (1)

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