An interventional study of PFM-specific motor imagery (PFM-MI) and Sit-to-stand motor imagery in Stress Urinary Incontinence, sponsored by Michal Kafri, PhD. Completed. Open to female participants. Per ClinicalTrials.gov, last updated 2026-11-12.
Sponsored by Michal Kafri, PhD · Not applicable, Interventional, and Treatment
Stress urinary incontinence (SUI) is common among postmenopausal women and is associated with pelvic floor muscle (PFM) weakness and impaired motor control. Motor imagery (MI), the mental simulation of a movement without overt execution, may enhance voluntary muscle activation and sensorimotor awareness.
This pilot randomized controlled trial compared the immediate effects of a single session of PFM-specific MI versus non-specific sit-to-stand MI on PFM maximal voluntary contraction, accessory muscle involvement, and MI quality in postmenopausal women with SUI.
Thirty postmenopausal women with SUI were randomly allocated to one of the two MI groups. Each participant attended one session of about 90 minutes, which included two guided MI sets with three actual maximal voluntary PFM contractions performed between them. PFM maximal voluntary contraction (Modified Oxford Scale), accessory muscle involvement, and MI quality were assessed before and after MI practice.
Background. PFM weakness and impaired motor control are key contributors to SUI. Many women have difficulty identifying and selectively activating their PFMs and may compensate by recruiting accessory muscles (diaphragm, abdominals, gluteals, hip adductors). MI, particularly kinesthetic imagery, may improve awareness, coordination, and activation of the PFMs, but evidence in postmenopausal women with SUI is limited.
Objectives. The primary objective is to compare the immediate effect of PFM-specific MI versus sit-to-stand MI on PFM maximal voluntary contraction. Secondary between-group objectives are to compare changes in accessory muscle involvement and in visual and kinesthetic imagery quality. Exploratory within-group objectives are to characterize changes in these outcomes within each group.
Participants. Thirty postmenopausal women with self-reported SUI (per the International Continence Society definition) were recruited from the community through flyers and social media. Exclusion criteria were malignant disease, central nervous system disorders, urinary tract infection, pelvic floor pain, previous pelvic surgery, and self-reported mental health disorders. All participants gave written informed consent.
Design and procedure. Pilot randomized controlled trial with a pre-post design and two parallel groups. The study was conducted individually in a quiet room of a pelvic floor unit at a general hospital. In a single session of about 90 minutes, participants completed demographic information and standardized questionnaires (UDI-6, UIQ-7), received a brief educational overview of PFM anatomy and function, performed the MI task, and were assessed before and 20 minutes after the task. Allocation used a computer-generated randomization sequence prepared and held by an independent investigator, who disclosed assignments only after baseline assessment, so that allocation was concealed from the investigator enrolling and assessing participants.
Intervention. Structured MI delivered in supine position after a Jacobson-type relaxation phase, using prerecorded scripts with visual and kinesthetic instructions. The PFM-MI script (4 min 24 s) guided four imagined PFM contractions; the sit-to-stand script (4 min 3 s) guided two imagined sit-to-stand transfers. Each script was played twice, with three actual maximal voluntary PFM contractions performed between the two imagery sets.
Outcomes. The primary outcome is PFM maximal voluntary contraction by digital palpation (Modified Oxford Scale, 0-5). Secondary outcomes are accessory muscle involvement (observer-rated, 0-3) and visual and kinesthetic MI quality (Movement Imagery Questionnaire rating scale, 1-7). Harms were assessed non-systematically by observation and participant self-report.
Sample size and analysis. As a pilot study, the target of 30 participants (about 15 per group) followed methodological recommendations for pilot trials and was not powered to detect small or moderate effects. Analyses use rank-based nonparametric methods: Wilcoxon rank-sum test for between-group comparisons of change scores and Wilcoxon signed-rank test for within-group changes (two-sided p \< 0.05).
653 studies on the registry are indexed under Urinary Incontinence, Stress; 121 are open to participants now.
This study's enrollment of 30 is below the median of 68 across 508 interventional studies indexed under Urinary Incontinence, Stress.
Browse Urinary Incontinence, Stress studies →This is the only study on the registry with Michal Kafri, PhD as lead sponsor.
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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.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants practice guided motor imagery of pelvic floor muscle contraction in a single session. After a relaxation phase, a prerecorded script (4 min 24 s) guides four imagined PFM contractions using visual and kinesthetic imagery. The script is delivered twice, and between the two sets participants perform three actual maximal voluntary PFM contractions.
Behavioral: PFM-specific motor imagery (PFM-MI)
Participants practice guided motor imagery of a sit-to-stand transfer, which does not refer to the pelvic floor, in a single session. After a relaxation phase, a prerecorded script (4 min 3 s) guides two imagined sit-to-stand transfers using visual and kinesthetic imagery. The script is delivered twice, and between the two sets participants perform three actual maximal voluntary PFM contractions.
Behavioral: Sit-to-stand motor imagery
Structured motor imagery procedure developed according to established MI guidelines. Participants lie supine and complete a Jacobson-based relaxation phase, then follow a prerecorded script (calm, monotone voice) with explicit visual ("see yourself performing the movement") and kinesthetic ("feel yourself performing the movement") instructions to imagine contracting the pelvic floor muscles (four imagined contractions per set). Two sets are delivered, with three actual maximal voluntary PFM contractions between them. Total session about 90 minutes including questionnaires, education, and assessments.
Same structured procedure, relaxation phase, position, delivery, and session timing as Intervention 1, but the prerecorded script guides participants to imagine two sit-to-stand transfers per set instead of PFM contractions. Three actual maximal voluntary PFM contractions are performed between the two sets.
Change in pelvic floor muscle maximal voluntary contraction
Assessed by digital vaginal palpation using the Modified Oxford Scale (0 = no discernible contraction; 5 = strong contraction with clear lift), with the participant supine, hips and knees flexed. Three consecutive maximal voluntary contractions are rated with short rests; the highest score is analyzed. Change = post minus pre.
Time frame: Before the motor imagery task (baseline) and 20 minutes after the task, within a single session of about 90 minutes
Change in accessory muscle involvement during pelvic floor muscle contraction
During each maximal voluntary contraction the examiner visually observes compensatory strategies: breath-holding, abdominal contraction or bulging, gluteal contraction, hip adduction, and posterior pelvic tilt. Level of involvement is rated on a 0-3 scale (0 = none or normal breathing; 3 = strong involvement or respiratory fixation). Change = post minus pre.
Time frame: Before the motor imagery task (baseline) and 20 minutes after the task, within a single session
Motor imagery quality
Ease of generating visual/kinesthetic imagery of the practiced movement (pelvic floor contraction or sit-to-stand), rated with the rating scale of the Movement Imagery Questionnaire-Revised on a 7-point scale (1 = very easy; 7 = very difficult ). Lower scores indicate greater ease.
Time frame: Immediately after the first and second imagery sets, within a single session
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
Ran from Nov 2016 to primary completion in Mar 2017, 4 months.
Of 226 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 4 months is below that.
Counting every sponsor, half of 267 studies reached it within 19 months; a quarter within 9 and three quarters within 43.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is completed, as verified in Nov 2026. You cannot join it, but the record below documents what was studied.
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