Trial · NCT07905586
Feasibility of Resisted Expiratory Muscle Training for Females Assigned at Birth With Stress Urinary Incontinence: A Pilot Study
NCT07905586, Not applicable, Not yet recruiting, Thomas Jefferson University
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Feasibility of Resisted Expiratory Muscle Training for Females Assigned at Birth With Stress Urinary Incontinence: A Pilot Study. Trials, record NCT07905586. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07905586
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Feasibility of Resisted Expiratory Muscle Training for Females Assigned at Birth With Stress Urinary Incontinence: A Pilot Study
- NCT number
- NCT07905586
- Status
- Not yet recruiting
- Phases
- Not applicable
- Enrollment
- 24 participants, estimated
- Lead sponsor
- Thomas Jefferson University
- Conditions
- Stress Urinary Incontinence
- Interventions
- Pelvic floor muscle training, Expiratory muscle strength training
- First posted
- 2026-10-29
- Last updated
- 2026-10-29
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Attrition | This is a post measure after completion of the 7 week study. | Attrition will be assessed as a feasibility outcome to evaluate participant retention throughout the study. Attrition will be defined as the proportion of enrolled participants who discontinue study participation before completing the final study visit (Visit 7). The attrition rate will be calculated by dividing the number of participants who withdraw or discontinue participation before study completion by the total number of participants enrolled, multiplied by 100. The number and percentage of participants who complete the study will also be reported. Reasons for withdrawal or discontinuation will be documented when available. Attrition and retention rates will be summarized descriptively using counts, percentages, and 95% confidence intervals to evaluate the feasibility of participant retention in the study. |
| Primary | Eligibility rates | This is a post measure after completion of the 7 week study. | Eligibility rate will be assessed as a feasibility outcome to evaluate the proportion of individuals screened who meet the study's eligibility criteria. The eligibility rate will be calculated by dividing the number of individuals determined to be eligible by the total number of individuals screened and multiplying by 100. Eligibility will be determined based on the study's prespecified inclusion and exclusion criteria, including an ICIQ-UI SF score of at least 6. The number and percentage of individuals who are eligible and ineligible will be summarized descriptively. Reasons for ineligibility will be documented when available. The eligibility rate will be reported as a percentage with a 95% confidence interval to evaluate the feasibility of identifying an appropriate study population. |
| Secondary | Global rating of change | at visit 7 which is 6 weeks after baseline. | The Global Rating of Change (GROC) is a patient-reported measure used to assess participants' perceived overall change in symptoms following the intervention. At the final study visit, participants will rate how their urinary incontinence symptoms have changed compared with their status before beginning the intervention. Responses will be recorded using a 7-point ordinal scale ranging from 1 (very much better) to 7 (very much worse), with a score of 4 indicating no change. Lower scores indicate greater perceived improvement, whereas higher scores indicate greater perceived worsening. The GROC will be administered at Visit 7 and used to characterize participants' overall perceptions of treatment-related change. |
| Secondary | Maximum expiratory pressure | at visit 4 which is 3 weeks after baseline. | Maximal expiratory pressure (MEP) is an objective measure of respiratory muscle strength that assesses the maximum pressure generated during a forceful expiration against an occluded airway. MEP will be measured using a respiratory pressure manometer and expressed in centimeters of water (cm H₂O). Participants will be seated and instructed to inhale maximally, followed by a forceful, sustained exhalation into the manometer mouthpiece. Measurements will be repeated according to a standardized testing protocol, with adequate rest between attempts to minimize fatigue. The highest acceptable and reproducible pressure value will be recorded for analysis. Higher MEP values indicate greater expiratory pressure-generating capacity and are used to characterize respiratory muscle strength at baseline and assess changes following the intervention. MEP will be measured at Visits 1, 4, and 7. |
| Secondary | Maximum expiratory pressure | at visit 7 which is 6 weeks after baseline | Maximal expiratory pressure (MEP) is an objective measure of respiratory muscle strength that assesses the maximum pressure generated during a forceful expiration against an occluded airway. MEP will be measured using a respiratory pressure manometer and expressed in centimeters of water (cm H₂O). Participants will be seated and instructed to inhale maximally, followed by a forceful, sustained exhalation into the manometer mouthpiece. Measurements will be repeated according to a standardized testing protocol, with adequate rest between attempts to minimize fatigue. The highest acceptable and reproducible pressure value will be recorded for analysis. Higher MEP values indicate greater expiratory pressure-generating capacity and are used to characterize respiratory muscle strength at baseline and assess changes following the intervention. MEP will be measured at Visits 1, 4, and 7. |
| Secondary | surface EMG | at visit 4 which is 3 weeks after baseline | Pelvic floor muscle activity will be assessed using vaginal surface electromyography (sEMG) with an intravaginal sensor to measure the amplitude of electrical activity generated during pelvic floor muscle contractions. A trained, licensed physical therapist with pelvic health training will position the vaginal sensor according to the device manufacturer's instructions. Participants will be instructed to perform a maxiumal and submaximal voluntary pelvic floor muscle contraction, and the sEMG system will record the resulting electrical activity. Amplitude will be expressed in microvolts (µV), with higher values generally indicating greater recorded electrical activity during contraction. Measurements will be obtained using a standardized testing protocol at Visits 1, 4, and 7 to characterize pelvic floor muscle activation and explore changes following the intervention. |
| Secondary | surface EMG | at visit 7 which is 4 weeks after baseline | Pelvic floor muscle activity will be assessed using vaginal surface electromyography (sEMG) with an intravaginal sensor to measure the amplitude of electrical activity generated during pelvic floor muscle contractions. A trained, licensed physical therapist with pelvic health training will position the vaginal sensor according to the device manufacturer's instructions. Participants will be instructed to perform a maxiumal and submaximal voluntary pelvic floor muscle contraction, and the sEMG system will record the resulting electrical activity. Amplitude will be expressed in microvolts (µV), with higher values generally indicating greater recorded electrical activity during contraction. Measurements will be obtained using a standardized testing protocol at Visits 1, 4, and 7 to characterize pelvic floor muscle activation and explore changes following the intervention. |
| Secondary | International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form | Baseline after consent; a score <6 will exclude from inclusion in the study. | The International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF) is a validated, self-administered questionnaire used to assess the frequency, amount, and impact of urinary incontinence on quality of life. The questionnaire consists of three scored items addressing the frequency of urinary leakage, the amount of urine typically leaked, and the degree to which urinary leakage interferes with everyday life. An additional unscored item asks participants to identify situations in which leakage occurs. Responses are scored on a scale from 0 to 21, with higher scores indicating greater symptom severity and greater impact of urinary incontinence. The total score is calculated by summing the three scored items. The instrument will be completed independently by participants on paper and scored manually. |
| Secondary | International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form | at visit 4 which is 3 weeks after baseline. | The International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF) is a validated, self-administered questionnaire used to assess the frequency, amount, and impact of urinary incontinence on quality of life. The questionnaire consists of three scored items addressing the frequency of urinary leakage, the amount of urine typically leaked, and the degree to which urinary leakage interferes with everyday life. An additional unscored item asks participants to identify situations in which leakage occurs. Responses are scored on a scale from 0 to 21, with higher scores indicating greater symptom severity and greater impact of urinary incontinence. The total score is calculated by summing the three scored items. The instrument will be completed independently by participants on paper and scored manually. |
| Secondary | International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form | at visit 7 which is 6 weeks after baseline. | The International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF) is a validated, self-administered questionnaire used to assess the frequency, amount, and impact of urinary incontinence on quality of life. The questionnaire consists of three scored items addressing the frequency of urinary leakage, the amount of urine typically leaked, and the degree to which urinary leakage interferes with everyday life. An additional unscored item asks participants to identify situations in which leakage occurs. Responses are scored on a scale from 0 to 21, with higher scores indicating greater symptom severity and greater impact of urinary incontinence. The total score is calculated by summing the three scored items. The instrument will be completed independently by participants on paper and scored manually. |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers4
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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