Effect of Knack Pelvic Floor Contraction on Sexual Dysfunction
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age25-45
SponsorCairo University
About this trial
This study aims to investigate the effect of knack pelvic floor contraction on sexual dysfunction in females with stress urinary incontinence.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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/m2.
They are multiparous women.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Interfrential stimulation
Other interventionThe participant will be positioned in semi-Fowler's position. Interferential therapy was given using the quadripolar method. Two electrodes were placed on the lower abdomen just above the outer half of the inguinal ligament, and another two on the inner aspect of the thigh near the origin of the adductor muscle. At the first treatment session, every participant will be examined for pelvic floor contraction by the finger palpation method using sterilized gloves to ensure the correct position of the electrodes. It will be set with intensity up to the tolerable limit of subjects, carrier frequency of 2000Hz, vector 900, rhythmic sweep frequency of 10-100Hz, and duration 20 minutes. Interferential therapy will be applied for the treatment procedure of all women in both groups for 20 minutes, 3days per week for 8 weeks.
Knack pelvic floor training
Other interventionThe knack technique (Fitz et al., 2021): * The patient will be instructed to lie in supine lying position with flexed knees. * Ask the patient to contract the pelvic floor muscles for 2-4 seconds and relax for 4 seconds for 15 repetitions with 3 sets before and during coughing or sneezing . * Contract the PFM before and during all daily activities involving effort, before and during coughing, sneezing, laughing, walking up and down stairs, jumping, running, bending, lifting a weight from the floor, holding a child, pushing furniture to prevent urine leakage. * Contract PFM and hold for 2-4 seconds, relax 4 seconds, with 3 sets of 15 repetitions.
Treatment groups
40 Participants
are divided into 2 treatment groupsGroup A: Interferential stimulationActive comparator 1 intervention
Group B: Interferential stimulation + Knack pelvic floor exerciseExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Assessment of pelvic floor muscle strength
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.
Time frame
8 weeks2
Assessment of sexual function
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)
Time frame
8 weeksSecondary outcomes
1
Assessment of symptoms of SUI
Incontinence Severity Index (ISI) will be used to assess SUI symptoms for all participating women in both groups before and after treatment program. All women in both groups will be asked to fill all items of questionnaire after a full explanation of them. The total score is the score for the first question multiplied by the score for the second question (0=dry, 1-2=slight, 3-4=moderate, 6-8=severe)
Time frame
8 weeks2
Assessment of quality of life
The world health organization quality of life questionnaire (WHOQOL) will be used to assess quality of life for all participating women in both groups before and after treatment. All women in both groups will be asked to fill all items of questionnaire after a full explanation of them.The score ranges from 0-20 indicating poor quality of life, 21-40 indicating moderate QOL, 41-60 indicating good QOL, and 61-80 indicating a very good QOL.
Time frame
8 weeksSponsors and contacts
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Source ClinicalTrials.gov
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