An interventional study of Interfrential stimulation and Knack pelvic floor training in Stress Urinary Incontinence (SUI) and Sexual Dysfunction, sponsored by Cairo University. Not yet recruiting at 1 site in Egypt. Open to female participants aged 25 Years to 45 Years. Per ClinicalTrials.gov, last updated 2025-08-28.
Sponsored by Cairo University · Not applicable, Interventional, and Treatment
This study aims to investigate the effect of knack pelvic floor contraction on sexual dysfunction in females with stress urinary incontinence.
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.
651 studies on the registry are indexed under Urinary Incontinence, Stress; 120 are open to participants now.
This study's planned enrollment of 40 is below the median of 68 across 506 interventional studies indexed under Urinary Incontinence, Stress.
Browse Urinary Incontinence, Stress studies →Cairo University is the lead sponsor of 4,941 studies on the registry; 1,458 are open to participants now.
Of its 37 completed or terminated interventional studies of FDA-regulated products, 5 (14%) have results posted.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Other: Interfrential stimulation
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.
Other: Interfrential stimulation · Other: Knack pelvic floor training
The 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.
The 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.
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 weeks
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 weeks
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 weeks
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 weeks
Start is estimated for Sep 2025; primary completion for Jan 2026, 4 months later.
Of 225 non-industry interventional studies with no phase under Urinary Incontinence, Stress, half reached primary completion within 19 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 43. This study's planned 4 months is below that.
Counting every sponsor, half of 266 studies reached it within 19 months; a quarter within 9 and three quarters within 43.
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This study is not yet recruiting, as verified in Aug 2025. You cannot join it, but the record below documents what was studied.
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