An interventional study of Rugby-Tailored Pelvic Floor Muscle Training Programme in Urinary Incontinence (UI) and Pelvic Floor Disorders, sponsored by Universidad de Granada. Recruiting at 1 site in Spain. Open to female participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-08-11.
Sponsored by Universidad de Granada · Not applicable, Interventional, and Treatment
This randomized controlled trial will evaluate whether a rugby-tailored pelvic floor muscle training programme reduces urinary incontinence symptoms and influences neuromuscular performance in professional and semi-professional women rugby players. A total of 48 players aged 18 to 45 years with self-reported urinary incontinence will be randomly assigned in a 1:1 ratio to the pelvic floor muscle training group or a control group.
The intervention group will complete an individualized, remotely supervised programme integrating pelvic floor muscle contractions, breathing and postural coordination, the "Knack" technique, progressive functional exercises, and rugby-relevant movement tasks. The control group will continue usual rugby training without study pelvic floor muscle training during the intervention period.
Outcomes will be measured at baseline and immediately after the intervention. The primary outcome is change in urinary incontinence severity measured with the International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF). Secondary outcomes include broader pelvic floor symptom screening, jump performance, maximal isometric lower-limb force, reactive strength, and programme adherence.
Urinary incontinence is common in women athletes and may affect training participation, confidence, concentration, and sporting performance. Rugby exposes athletes to repeated impacts, rapid decelerations, collisions, and high trunk and intra-abdominal pressure demands. Conventional pelvic floor muscle training may not fully reflect these sport-specific demands.
This study is a two-arm, parallel-group randomized controlled trial. Eligible participants will be randomized in a 1:1 ratio using a computer-generated sequence prepared by an independent researcher. Allocation will be concealed using sealed, opaque envelopes.
Participants allocated to the intervention will complete a rugby-tailored pelvic floor muscle training programme delivered remotely by certified pelvic health physiotherapists and sport scientists. The programme includes education, breathing and posture coordination, pelvic floor contractions in different positions, pre-activation before high-impact tasks ("the Knack"), progressive functional strength and landing tasks, technique correction, and individualized progression. Participants will continue their usual rugby training. Control participants will continue usual rugby training and will not complete the study exercise programme during the intervention period. After post-intervention assessment, control participants will be offered the programme materials and a remote advisory session.
Assessments will combine self-reported pelvic floor outcomes with force-plate measures. The ICIQ-UI SF and Pelvic Floor Dysfunction Screening Tool (PFD-SENTINEL) will be completed at baseline and post-intervention. Neuromuscular testing will include countermovement jumps, an isometric strength test, and a reactive jump assessment. Adherence will be monitored using participant records, physiotherapist logs, and remote-session attendance. The principal analysis will compare changes over time between groups using a mixed-effects model or equivalent repeated-measures approach, with sensitivity analyses adjusted for baseline outcome values and relevant participant and training characteristics.
983 studies on the registry are indexed under Urinary Incontinence; 180 are open to participants now.
This study's planned enrollment of 48 is below the median of 66 across 739 interventional studies indexed under Urinary Incontinence.
Browse Urinary Incontinence studies →Universidad de Granada is the lead sponsor of 246 studies on the registry; 43 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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.
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.
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 will continue usual rugby training and complete the remotely supervised rugby-tailored pelvic floor muscle training programme. The intervention includes pelvic floor and deep abdominal muscle coordination, breathing and posture exercises, progressive contractions in different positions, the "Knack" before impact-related tasks, functional strength and landing exercises, individualized progression, and remote technique feedback.
Behavioral: Rugby-Tailored Pelvic Floor Muscle Training Programme
Participants will continue their usual rugby training and will not complete the study pelvic floor muscle exercise programme during the intervention period. After post-intervention assessment, they will be offered access to the programme materials and one remote advisory session with a pelvic health physiotherapist.
The intervention is an individualized, remotely delivered pelvic floor training programme designed for women rugby players. It combines: (1) pelvic floor muscle awareness, activation, and complete relaxation; (2) coordination with the transversus abdominis, breathing, and posture; (3) progressive pelvic floor contractions in lying, quadruped, standing, and dynamic positions; (4) the "Knack," involving pelvic floor pre-activation before impact or high-pressure tasks; (5) progressive rugby-relevant functional tasks such as squatting, jumping, landing, and repeated impact preparation; and (6) individualized feedback from certified pelvic health physiotherapists. Dose: 8 weeks, with 3 sessions per week. Adherence is monitored using participant self-reports, physiotherapist records, and remote-session attendance.
Change in International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-SF) total score
Urinary incontinence symptom severity will be assessed using the International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-SF). The questionnaire contains three scored items assessing urinary-leakage frequency, amount of leakage and interference with everyday life. The total score ranges from 0 to 21 points, with higher scores indicating greater urinary incontinence severity and impact and therefore a worse outcome. Change will be calculated as the score at 8 weeks minus the baseline score; a negative change indicates improvement. The primary endpoint will be the between-group difference in change from baseline to 8 weeks.
Time frame: Baseline and immediately after the intervention (8 weeks)
Change in Pelvic Floor Dysfunction Screening Tool in Female Athletes (PFD-SENTINEL) symptom count
Pelvic floor dysfunction symptoms will be assessed using the Pelvic Floor Dysfunction Screening Tool in Female Athletes, known as PFD-SENTINEL. The instrument includes five binary pelvic floor symptom indicators. A study-defined symptom count will be calculated by summing the number of symptoms reported, producing a score from 0 to 5. Higher scores indicate a greater number of pelvic floor dysfunction symptom categories and therefore a worse outcome. A count of at least one symptom meets the PFD-SENTINEL criterion for direct referral to a pelvic floor specialist. Change will be calculated as the score at 8 weeks minus the baseline score; a negative change indicates improvement.
Time frame: Baseline and immediately after the intervention (8 weeks)
Change in Pelvic Floor Dysfunction Screening Tool in Female Athletes (PFD-SENTINEL) risk, clinical and sport-related item count
Risk factors and clinical and sport-related characteristics will be assessed using the Pelvic Floor Dysfunction Screening Tool in Female Athletes, known as PFD-SENTINEL. The instrument contains 28 binary risk, clinical and sport-related items. A study-defined item count will be calculated by summing the number of items reported, producing a score from 0 to 28. Higher scores indicate a greater number of characteristics associated with potential pelvic floor dysfunction and therefore a worse outcome. A count of 14 or more items meets the PFD-SENTINEL criterion for direct referral to a pelvic floor specialist. Change will be calculated as the score at 8 weeks minus the baseline score; a negative change indicates improvement.
Time frame: Baseline and immediately after the intervention (8 weeks)
Change in countermovement jump height
Countermovement jump height will be assessed using a force plate. Participants will perform three maximal countermovement jumps with their hands maintained on their hips. Jump height will be recorded in centimetres. Higher values indicate greater vertical jump performance and therefore a better outcome. The highest value obtained from the three valid trials will be used for analysis.
Time frame: Baseline and immediately after the intervention (8 weeks)
Change in maximal isometric squat peak force
Lower-body maximal isometric strength will be assessed using a force plate during three maximal isometric squat trials performed at a knee angle of approximately 110 degrees. Peak force will be recorded in newtons. Higher values indicate greater maximal isometric strength and therefore a better outcome. The highest peak-force value obtained from the three valid trials will be used for analysis.
Time frame: Baseline and immediately after the intervention (8 weeks)
Change in Reactive Strength Index during the countermovement rebound jump
Reactive jump performance will be assessed using a force plate during three maximal countermovement rebound jump trials performed with the hands maintained on the hips. Reactive Strength Index will be calculated as rebound jump height in metres divided by ground contact time in seconds and will be expressed in metres per second. Higher values indicate greater reactive jump performance and therefore a better outcome. The highest Reactive Strength Index obtained from the three valid trials will be used for analysis.
Time frame: Baseline and immediately after the intervention (8 weeks)
Change in self-reported amount of urinary leakage during the countermovement jump test
Immediately after completing the three countermovement jump trials, participants will report the amount of urinary leakage experienced during the test using the response categories from the amount-of-leakage item of the International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form. The item is scored as 0 = no leakage, 2 = a small amount, 4 = a moderate amount, and 6 = a large amount. Possible scores range from 0 to 6, with higher scores indicating a greater amount of urinary leakage and therefore a worse outcome. Change will be calculated as the score at 8 weeks minus the baseline score; a negative change indicates improvement.
Time frame: Baseline and immediately after the intervention (8 weeks)
Change in self-reported amount of urinary leakage during the isometric squat test
Immediately after completing the three maximal isometric squat trials performed at a knee angle of approximately 110 degrees, participants will report the amount of urinary leakage experienced during the test using the response categories from the amount-of-leakage item of the International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form. The item is scored as 0 = no leakage, 2 = a small amount, 4 = a moderate amount, and 6 = a large amount. Possible scores range from 0 to 6, with higher scores indicating a greater amount of urinary leakage and therefore a worse outcome. Change will be calculated as the score at 8 weeks minus the baseline score; a negative change indicates improvement.
Time frame: Baseline and immediately after the intervention (8 weeks)
Change in self-reported amount of urinary leakage during the countermovement rebound jump test
Immediately after completing the three countermovement rebound jump trials, participants will report the amount of urinary leakage experienced during the test using the response categories from the amount-of-leakage item of the International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form. The item is scored as 0 = no leakage, 2 = a small amount, 4 = a moderate amount, and 6 = a large amount. Possible scores range from 0 to 6, with higher scores indicating a greater amount of urinary leakage and therefore a worse outcome. Change will be calculated as the score at 8 weeks minus the baseline score; a negative change indicates improvement.
Time frame: Baseline and immediately after the intervention (8 weeks)
Adherence to the pelvic floor muscle training programme
Throughout the intervention period (weeks 1-8)
Time frame: Adherence will be summarized as the percentage of prescribed home-training sessions completed, based on weekly participant self-reports.
Plan to share: No — There is no current plan to share de-identified individual participant data with researchers outside the primary study team. The study protocol and participant consent procedures did not prospectively establish a mechanism for external IPD sharing. Study findings will be disseminated through aggregate analyses in peer-reviewed publications, research reports, and scientific presentations.
Start is estimated for Sep 2026; primary completion for Dec 2026, 3 months later.
Of 301 non-industry interventional studies with no phase under Urinary Incontinence, half reached primary completion within 15 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 37. This study's planned 3 months is below that.
Counting every sponsor, half of 364 studies reached it within 15 months; a quarter within 7 and three quarters within 35.
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