Stress Urinary Incontinence (SUI)NCT07145216
Effect of Knack Pelvic Floor Contraction on Sexual Dysfunction
A study testing Interfrential stimulation and Knack pelvic floor training in people with Stress Urinary Incontinence (SUI) and Sexual Dysfunction, run by Cairo University at 1 site in Egypt.
Trial summary
This study aims to investigate the effect of knack pelvic floor contraction on sexual dysfunction in females with stress urinary incontinence. Read more about this study
- Who is it for?
- Ages 25 to 45 years, women only
- Conditions the study is for
- Stress Urinary Incontinence (SUI), Sexual Dysfunction
- What is being tested?
- Interfrential stimulation and Knack pelvic floor training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Sep 2025to 30 Jan 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
- Females complain of sexual disorders related to SUI, identified by an FSFI score of less than 28.1
- They have a sedentary lifestyle.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site
Faculty of Physical Therapy
Giza
Wafaa I. Hussein, B.Sc, 01005660816, wafaaibraheem1801@gmail.com
Manal A El-Shafei, PHD, manal.ahmed@pt.cu.edu.eg
About this study
Official title: Effect of Knack Pelvic Floor Contraction on Sexual Dysfunction in Females With Stress Urinary Incontinence
This study aims to investigate the effect of knack pelvic floor contraction on sexual dysfunction in females with stress urinary incontinence.
Read the detailed description
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.
- Being tested
- Interfrential stimulation, Knack pelvic floor training
- Medical subject headings
- Urinary Incontinence, Stress, Sexual Dysfunction, Physiological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interfrential stimulationOther
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.
Knack pelvic floor trainingOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Interfrential stimulation |
| 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. Receives: Other: Interfrential stimulation; Other: Knack pelvic floor training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
Measured: 8 weeks
Secondary outcomes (2)
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)
Measured: 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.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2025
- Study start1 Sep 2025 (estimated)
- Primary completion1 Jan 2026 (estimated)
- Study completion30 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stress Urinary Incontinence (SUI)Studies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wafaa Ibrahim Hussein, Cairo University
- Investigators
- Doaa A. Osman, PHD, Study chair, Department of Women's Health, Faculty of Physical Therapy, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07145216
- Sponsor's protocol ID
- P.T.REC/012/005672
- Status last verified
- Aug 2025
- First submitted
- 21 Aug 2025
- Last updated
- 28 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Knack Pelvic Floor Contraction on Sexual Dysfunction in Females With Stress Urinary Incontinence
- ClinicalTrials.gov ID
- NCT07145216
- Acronym / sponsor ID
- P.T.REC/012/005672
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Sep 2025 (estimated)
- Primary completion
- 1 Jan 2026 (estimated)
- Study completion
- 30 Jan 2026 (estimated)
- First posted
- 28 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to investigate the effect of knack pelvic floor contraction on sexual dysfunction in females with stress urinary incontinence.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Interferential stimulation | Active comparator | Other: Interfrential stimulationIt 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. |
| Interferential stimulation + Knack pelvic floor exercise | Experimental | Other: Interfrential stimulation, Other: Knack pelvic floor trainingIt 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. |
Who may qualify
- Ages
- 25 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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.
- Females complain of sexual disorders related to SUI, identified by an FSFI score of less than 28.1
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Interfrential stimulationThe 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. | Other | Interferential stimulation, Interferential stimulation + Knack pelvic floor exercise |
| Knack pelvic floor trainingThe 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. | Other | Interferential stimulation + Knack pelvic floor exercise |
Primary outcome
Assessment of pelvic floor muscle strength
Time frame: 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
Time frame: 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)
2 secondary outcomes
Assessment of symptoms of SUI
Time frame: 8 weeks
Assessment of quality of life
Time frame: 8 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Doaa A. Osman, PHD study chair
Department of Women's Health, Faculty of Physical Therapy, Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Interfrential stimulation and Knack pelvic floor training in people with Stress Urinary Incontinence (SUI) and Sexual Dysfunction, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 28 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Wafaa I. Hussein, B.Sc (01005660816, wafaaibraheem1801@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of pelvic floor muscle strength (time frame: 8 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2025.