Stress Urinary IncontinenceNCT05341024
Pelvic Floor Muscle Training in Female CrossFit and Functional Fitness Exercisers
A study testing Pelvic Floor Muscle Training in female CrossFit and functional fitness exercisers in people with Stress Urinary Incontinence and Pelvic Floor Disorders, run by Norwegian School of Sport Sciences at 1 site in Norway.
Trial summary
There is a high prevalence of urinary incontinence (UI) among female athletes and exercisers, especially in sports including high impact activities and heavy weightlifting. CrossFit and functional fitness is a popular exercise form, including a combination of heavy lifting and high impact activities at high… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Stress Urinary Incontinence, Pelvic Floor Disorders, Urinary Incontinence
- What is being tested?
- Pelvic Floor Muscle Training in female CrossFit and functional fitness exercisers
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 1 siteNorway
- Study dates
- 2 May 2022to 19 Apr 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18
- ≥ 6 months of consistent participation in CrossFit or functional fitness training
- Participating in ≥ 3 sessions of cross-fit training per week
- Self-reported SUI and a total score on ICIQ-UI-SF of ≥ 3. A change of the ICIQ-UI-SF score of 2.5 has been identified to be the minimal important difference (MID) and 1.58 as between-treatment MID (Nystrom et al., 2015).
- No musculoskeletal injuries for the past 6 months with negative effect on training participation
Who cannot join
- Ongoing pregnancy, or planning to get pregnant during the intervention period
- History of hysterectomy or pelvic surgery to correct UI or POP
- History of musculoskeletal injuries for the past 6 months with negative effect on training participation
- Parous women who are ≤12 months post-partum
Trial locations and contacts
1 site in 1 country.
Norway1 site
Norwegian School of Sport Sciences, Department of Sport Medicine
Oslo, 0863
About this study
Official title: Effect of Pelvic Floor Muscles Training on Symptoms, Bother and Amount of Stress Urinary Incontinence in Female CrossFit and Functional Fitness Exercisers. An Assessor Blinded Randomized Controlled Trial
There is a high prevalence of urinary incontinence (UI) among female athletes and exercisers, especially in sports including high impact activities and heavy weightlifting. CrossFit and functional fitness is a popular exercise form, including a combination of heavy lifting and high impact activities at high intensities. In several recent studies, high prevalence rates of UI have been reported among female CrossFit/functional fitness exercisers. UI is defined as "the complaint of involuntary loss of urine". Stress urinary incontinence (SUI) is the most common type of UI and is defined as "the complaint of involuntary loss of urine on effort or physical exertion (e.g. sporting activities), or or sneezing or coughing". Urinary leakage during sport activities may affect athletes' and exercisers' performance, cause bother, frustration and embarrassment and furthermore lead to avoidance and cessation of sport activities. Pelvic floor muscle (PFM) training is highly effective in treating SUI in the general female population. However, evidence of the effect of PFM training in exercisers participating in high impact and heavy weightlifting activities is sparse.
The purpose of this assessor-blinded randomized controlled trial (RCT) is to assess the effect of PFM training on symptoms, bother and amount of SUI in female CrossFit/functional fitness exercisers.
Read the detailed description
BACKGROUND:
Physical activity and exercise have well-known beneficial effects on several physical and psychological health outcomes. However, it has been proposed that regular participation in physical activity and exercise may lead to greater risk of developing pelvic floor dysfunctions (PFD) in women. The pelvic floor consists of muscles, fascia and ligaments and forms a hammock-like support at the base of the abdomino-pelvic cavity. The function of the pelvic floor is to provide support to the pelvic organs (the bladder, urethra, vagina, uterus and rectum) and to counteract all increases in intra-abdominal pressure and ground reactions forces during daily activities. Additionally, the pelvic floor facilitates intercourse, vaginal birth, storage of stool and urine and voluntary defecation and urination. A dysfunctional pelvic floor can lead to urinary and anal incontinence, pelvic organ prolapse, sexual problems and chronic pain syndromes. UI is the most common PFD, defined as "the complaint of involuntary loss of urine". SUI, urgency urinary incontinence (UUI) and mixed urinary incontinence (MUI) are common subtypes of UI. In women, SUI accounts for approximately half of all incontinence types and is defined as "the complaint of involuntary loss of urine on effort or physical exertion (e.g. sporting activities), or on sneezing or coughing". UUI is defined as the "complaint of involuntary loss of urine associated with urgency" and MUI as "complaints of both stress and urgency urinary incontinence".
High prevalence rates of UI among both parous and nulliparous female athletes and exercisers have been reported in several cross-sectional studies. The prevalence rates varies between 0-80% with the highest prevalence found in high impact sports such as trampoline jumping, gymnastics and strengths sports with high increases in intraabdominal pressure (e.g. powerlifting). CrossFit and functional fitness, which are trending exercise forms, includes a combination of heavy lifting and high impact activities at high intensities. High prevalence of UI among CrossFit/functional fitness exercisers has been reported in several recent cross-sectional studies, ranging from 41-84%. Leakage during sport and exercise may affect performance and cause bother, frustration and embarrassment, and may further lead to avoidance or cessation of sport and exercise.
To date, there is level 1 evidence and grade A recommendation for PFM training alone to be first line treatment for SUI, MUI and pelvic organ prolapse in the general female population. In addition, PFM training is highly effective as primary prevention; pregnant continent women who exercise the PFM are at 62% less risk of UI in late pregnancy and 29% less risk of UI 3-6 months postpartum. Evidence of the effect of PFM training in athletes or strenuous exercisers is sparse.
In one study on female soldiers and two small case series in female athletes and exercisers, PFM training led to reduced symptoms of UI. However, none of these studies included a non-treated control group and the internal validity is therefore low. To our knowledge, only one RCT has assessed effects of PFM training on SUI in athletes. Female volleyball players (n=16) who followed a PFM training program had significant improvements of SUI compared to a control group (n=16).
Based on today's knowledge we do not know whether PFM training is effective in strenuous exposed to excessive impact and increases in intraabdominal pressure during CrossFit- and functional fitness activities. Given the high impact on the pelvic floor in these exercisers, it is presumed that they need much better pelvic floor muscle function than non-exercisers. On the other hand, these exercisers may be motivated for regular training. Strength training of the PFM, if proven effective, may be easily incorporated in their basic training regimens both as prevention and treatment strategies of SUI.
AIMS:
The aim of this RCT is to assess the effect of PFM training on symptoms, bother and amount of SUI among female CrossFit and functional fitness exercisers.
STUDY DESIGN AND METHODS:
To recruit participants, we will contact CrossFit boxes and functional fitness clubs in or near Oslo. Social media platforms (such as Facebook, Instagram) will also be used. The study is an assessor-blinded RCT evaluating the effect of PFM training on SUI in CrossFit and functional fitness exercisers. At baseline, a pelvic floor muscle assessment (resting pressure, strength and endurance) will be performed of all participants. In addition, the participants will respond to an electronic questionnaire, measuring self-reported symptoms of UI and bother. The participants will be randomly assigned to either a PFM training group (EG) or a control group (CG) with no intervention. The intervention consists of a daily home-based PFM training program with weekly follow-up by a physiotherapist. After a 16-week intervention period, all participants will perform a post-test including the same previous mentioned outcome measures.
- Being tested
- Pelvic Floor Muscle Training in female CrossFit and functional fitness exercisers
- Medical subject headings
- Urinary Incontinence, Stress, Pelvic Floor Disorders, Urinary Incontinence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pelvic Floor Muscle Training in female CrossFit and functional fitness exercisersOther
The intervention will consist of a home-based PFM training program with weekly follow-up by phone by a physiotherapist. Before commencing PFM training, the participants in the intervention group will have an individual session with a physiotherapist including thorough teaching on how to perform a correct PFM contraction (clinical exams of pelvic floor muscle function by observation and vaginal digital palpation) and instructions on how to perform the training program. The program consists of 3 sets of 8-12 maximum contractions per day. An electronic app (Athlete monitoring) will be used to assess adherence to the program. The participants will be asked to register their training sessions in a personal account. A reminder to adhere to the program will be sent by phone. The training period will be 16 weeks and the exercises will take approximately 10 minutes per day to perform.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | 16 weeks home-based PFM training program with weekly follow-up by a physiotherapist Receives: Other: Pelvic Floor Muscle Training in female CrossFit and functional fitness exercisers |
| Control Group | No intervention | No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
The International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI-SF)
A reliable and valid questionnaire assessing self-reported prevalence, amount of leakage, bother and type of UI. A change in ICIQ-UI-SF score of 1.58 points will be considered as between-treatment minimum important difference.
Measured: Change in total score from baseline at four months
Secondary outcomes (7)
Pelvic Floor Muscle Resting Pressure
Measurement of vaginal resting pressure will be measured with manometry. A high precision pressure transducer connected to a vaginal balloon catheter (Camtech AS, Sandvika Norway) will be used. The method has demonstrated good intra-observer reliability (intraclass correlation coefficient: >90). Vaginal resting pressure will be recorded in cmH2O.
Measured: Change in pressure value from baseline at four months
Pelvic Floor Muscle Strength
We will use manometry to assess pressure rise generated during a maximum voluntary contraction of the PFM (PFM strength). A high precision pressure transducer connected to a vaginal balloon catheter (Camtech AS, Sandvika Norway) will be used. The method has demonstrated good intra-observer reliability (intraclass correlation coefficient: >90). Average peak pressure from 3 different PFM maximum voluntary contraction will be used to report PFM strength, recorded in cmH2O.
Measured: Change in pressure value from baseline at four months
Pelvic Floor Muscle Endurance
We will use manometry to assess the participants ability to perform a 10 seconds sustained PFM contraction (PFM endurance). A high precision pressure transducer connected to a vaginal balloon catheter (Camtech AS, Sandvika Norway) will be used. The method has demonstrated good intra-observer reliability (intraclass correlation coefficient: >90). PFM endurance will be reported as the area under the pressure curve in cmH2O multiplied by the duration of the contraction (10 s).
Measured: Change in pressure value from baseline at four months
Self-Efficacy Scale for Practicing Pelvic Floor Exercises (SESPPFE)
The participants will be asked to rate their self-efficacy (from 0-100) on 16 different items regarding PFM training. The scale have been tested to have good internal consistency (α = 0.92) and acceptable reliability (rho = 0.89).
Measured: At baseline in both groups. Participants in the intervention group will also be asked to answer the questionnaire again within the first month of the intervention period
Anal incontinence
Questions from patient-reported outcome measures (PROM) with Grade A recommendation from the International Consensus on Incontinence 2017 will be used to assess prevalence and bother of anal incontinence (ICIQ-B)
Measured: Change in score from baseline at four months
Pelvic Organ Prolapse
Questions from patient-reported outcome measures (PROM) with Grade A recommendation from the International Consensus on Incontinence 2017 will be used to assess prevalence and bother of pelvic organ prolapse (ICIQ-VS).
Measured: Change in score from baseline at four months
Patient Global Impression of Improvement (PGI-I) Scale
The participants will be asked to rate their perceived change of the condition. A validated 7-point scale with response choices ranging from "very much better" to "very much worse" will be used.
Measured: Post-test after a 4-months intervention period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2022
- Study start2 May 2022
- Primary completion19 Apr 2023
- Study completion19 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (36)Papers the sponsor has linked to this study.
- Other trials for Stress Urinary IncontinenceStudies of the same condition, open and under way.
- 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
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Norwegian School of Sport Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kari Bø, Norwegian School of Sport Sciences
- Investigators
- Kari Bø, PhD, Study chair, Norwegian School of School of Sport Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05341024
- Sponsor's protocol ID
- KLS2022
- Status last verified
- Mar 2024
- First submitted
- 4 Apr 2022
- Last updated
- 22 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Piercy KL, Troiano RP. Physical Activity Guidelines for Americans From the US Department of Health and Human Services. Circ Cardiovasc Qual Outcomes. 2018 Nov;11(11):e005263. doi: 10.1161/CIRCOUTCOMES.118.005263. No abstract available.
PubMed 30571339Ruiz-Zapata, A. M., Feola, A. J., Heesakkers, J., de Graaf, P., Blaganje, M., & Sievert, K. D. (2018). Biomechanical Properties of the Pelvic Floor and its Relation to Pelvic Floor Disorders. European Urology Supplements, 17(3), 80-90.
Bump RC, Norton PA. Epidemiology and natural history of pelvic floor dysfunction. Obstet Gynecol Clin North Am. 1998 Dec;25(4):723-46. doi: 10.1016/s0889-8545(05)70039-5.
PubMed 9921553Milsom, I., Altman, D., Cartwright, R., Lapitan, M. C. M., Nelson, R., Sjöström, S., & Tikkinen, K. A. O. (2017). Epidemiology of urinary incontinence (UI) and other lower urinary tract symptoms (LUTS), pelvic organ prolapse (POP) and anal (AI) incontinence. In P. C. Abrams, L.; Wagg, A.; Wein, A. (Ed.), Incontinence (Vol. 1, pp. 1-141). Tokyo: 6th International Consultation on Incontinence.
Haylen BT, de Ridder D, Freeman RM, Swift SE, Berghmans B, Lee J, Monga A, Petri E, Rizk DE, Sand PK, Schaer GN. An International Urogynecological Association (IUGA)/International Continence Society (ICS) joint report on the terminology for female pelvic floor dysfunction. Int Urogynecol J. 2010 Jan;21(1):5-26. doi: 10.1007/s00192-009-0976-9. Epub 2009 Nov 25.
PubMed 19937315Bø, K. (2015). Pelvic floor dysfunction, prevention and treatment in elite athletes. In K. Bø, B. Berghmans, S. Mørkved, & M. Van Kampen (Eds.), Evidence based Physical Therapy for the Pelvic Floor - Bridging science and clinical practice (pp. 397-407). Edinburgh London New York Oxford Philadelphia St Louis Sydney Toronto: Elsevier Churchilll Livingstone.
de Mattos Lourenco TR, Matsuoka PK, Baracat EC, Haddad JM. Urinary incontinence in female athletes: a systematic review. Int Urogynecol J. 2018 Dec;29(12):1757-1763. doi: 10.1007/s00192-018-3629-z. Epub 2018 Mar 19.
PubMed 29552736Nygaard IE, Shaw JM. Physical activity and the pelvic floor. Am J Obstet Gynecol. 2016 Feb;214(2):164-171. doi: 10.1016/j.ajog.2015.08.067. Epub 2015 Sep 6.
PubMed 26348380Jacome C, Oliveira D, Marques A, Sa-Couto P. Prevalence and impact of urinary incontinence among female athletes. Int J Gynaecol Obstet. 2011 Jul;114(1):60-3. doi: 10.1016/j.ijgo.2011.02.004. Epub 2011 May 14.
PubMed 21571270Nygaard IE, Thompson FL, Svengalis SL, Albright JP. Urinary incontinence in elite nulliparous athletes. Obstet Gynecol. 1994 Aug;84(2):183-7.
PubMed 8041527Poswiata A, Socha T, Opara J. Prevalence of stress urinary incontinence in elite female endurance athletes. J Hum Kinet. 2014 Dec 30;44:91-6. doi: 10.2478/hukin-2014-0114. eCollection 2014 Dec 9.
PubMed 25713669Eliasson K, Edner A, Mattsson E. Urinary incontinence in very young and mostly nulliparous women with a history of regular organised high-impact trampoline training: occurrence and risk factors. Int Urogynecol J Pelvic Floor Dysfunct. 2008 May;19(5):687-96. doi: 10.1007/s00192-007-0508-4. Epub 2008 Jan 26.
PubMed 18224267Skaug KL, Engh ME, Frawley H, Bo K. Prevalence of Pelvic Floor Dysfunction, Bother, and Risk Factors and Knowledge of the Pelvic Floor Muscles in Norwegian Male and Female Powerlifters and Olympic Weightlifters. J Strength Cond Res. 2022 Oct 1;36(10):2800-2807. doi: 10.1519/JSC.0000000000003919. Epub 2020 Dec 3.
PubMed 33278274Wikander L, Kirshbaum MN, Waheed N, Gahreman DE. Urinary Incontinence in Competitive Women Powerlifters: A Cross-Sectional Survey. Sports Med Open. 2021 Dec 7;7(1):89. doi: 10.1186/s40798-021-00387-7.
PubMed 34874496Wikander L, Kirshbaum MN, Waheed N, Gahreman DE. Urinary Incontinence in Competitive Women Weightlifters. J Strength Cond Res. 2022 Nov 1;36(11):3130-3135. doi: 10.1519/JSC.0000000000004052. Epub 2021 Jun 3.
PubMed 34100787
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Pelvic Floor Muscles Training on Symptoms, Bother and Amount of Stress Urinary Incontinence in Female CrossFit and Functional Fitness Exercisers. An Assessor Blinded Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05341024
- Acronym / sponsor ID
- KLS2022
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Norwegian School of Sport SciencesUniversity, hospital or other
- Study start
- 2 May 2022 (actual)
- Primary completion
- 19 Apr 2023 (actual)
- Study completion
- 19 Apr 2023 (actual)
- First posted
- 22 Apr 2022 (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.
There is a high prevalence of urinary incontinence (UI) among female athletes and exercisers, especially in sports including high impact activities and heavy weightlifting. CrossFit and functional fitness is a popular exercise form, including a combination of heavy lifting and high impact activities at high intensities. In several recent studies, high prevalence rates of UI have been reported among female CrossFit/functional fitness exercisers. UI is defined as "the complaint of involuntary loss of urine". Stress urinary incontinence (SUI) is the most common type of UI and is defined as "the complaint of involuntary loss of urine on effort or physical exertion (e.g. sporting activities), or or sneezing or coughing". Urinary leakage during sport activities may affect athletes' and exercisers' performance, cause bother, frustration and embarrassment and furthermore lead to avoidance and cessation of sport activities. Pelvic floor muscle (PFM) training is highly effective in treating SUI in the general female population. However, evidence of the effect of PFM training in exercisers participating in high impact and heavy weightlifting activities is sparse.
The purpose of this assessor-blinded randomized controlled trial (RCT) is to assess the effect of PFM training on symptoms, bother and amount of SUI in female CrossFit/functional fitness exercisers.
Detailed description
BACKGROUND:
Physical activity and exercise have well-known beneficial effects on several physical and psychological health outcomes. However, it has been proposed that regular participation in physical activity and exercise may lead to greater risk of developing pelvic floor dysfunctions (PFD) in women. The pelvic floor consists of muscles, fascia and ligaments and forms a hammock-like support at the base of the abdomino-pelvic cavity. The function of the pelvic floor is to provide support to the pelvic organs (the bladder, urethra, vagina, uterus and rectum) and to counteract all increases in intra-abdominal pressure and ground reactions forces during daily activities. Additionally, the pelvic floor facilitates intercourse, vaginal birth, storage of stool and urine and voluntary defecation and urination. A dysfunctional pelvic floor can lead to urinary and anal incontinence, pelvic organ prolapse, sexual problems and chronic pain syndromes. UI is the most common PFD, defined as "the complaint of involuntary loss of urine". SUI, urgency urinary incontinence (UUI) and mixed urinary incontinence (MUI) are common subtypes of UI. In women, SUI accounts for approximately half of all incontinence types and is defined as "the complaint of involuntary loss of urine on effort or physical exertion (e.g. sporting activities), or on sneezing or coughing". UUI is defined as the "complaint of involuntary loss of urine associated with urgency" and MUI as "complaints of both stress and urgency urinary incontinence".
High prevalence rates of UI among both parous and nulliparous female athletes and exercisers have been reported in several cross-sectional studies. The prevalence rates varies between 0-80% with the highest prevalence found in high impact sports such as trampoline jumping, gymnastics and strengths sports with high increases in intraabdominal pressure (e.g. powerlifting). CrossFit and functional fitness, which are trending exercise forms, includes a combination of heavy lifting and high impact activities at high intensities. High prevalence of UI among CrossFit/functional fitness exercisers has been reported in several recent cross-sectional studies, ranging from 41-84%. Leakage during sport and exercise may affect performance and cause bother, frustration and embarrassment, and may further lead to avoidance or cessation of sport and exercise.
To date, there is level 1 evidence and grade A recommendation for PFM training alone to be first line treatment for SUI, MUI and pelvic organ prolapse in the general female population. In addition, PFM training is highly effective as primary prevention; pregnant continent women who exercise the PFM are at 62% less risk of UI in late pregnancy and 29% less risk of UI 3-6 months postpartum. Evidence of the effect of PFM training in athletes or strenuous exercisers is sparse.
In one study on female soldiers and two small case series in female athletes and exercisers, PFM training led to reduced symptoms of UI. However, none of these studies included a non-treated control group and the internal validity is therefore low. To our knowledge, only one RCT has assessed effects of PFM training on SUI in athletes. Female volleyball players (n=16) who followed a PFM training program had significant improvements of SUI compared to a control group (n=16).
Based on today's knowledge we do not know whether PFM training is effective in strenuous exposed to excessive impact and increases in intraabdominal pressure during CrossFit- and functional fitness activities. Given the high impact on the pelvic floor in these exercisers, it is presumed that they need much better pelvic floor muscle function than non-exercisers. On the other hand, these exercisers may be motivated for regular training. Strength training of the PFM, if proven effective, may be easily incorporated in their basic training regimens both as prevention and treatment strategies of SUI.
AIMS:
The aim of this RCT is to assess the effect of PFM training on symptoms, bother and amount of SUI among female CrossFit and functional fitness exercisers.
STUDY DESIGN AND METHODS:
To recruit participants, we will contact CrossFit boxes and functional fitness clubs in or near Oslo. Social media platforms (such as Facebook, Instagram) will also be used. The study is an assessor-blinded RCT evaluating the effect of PFM training on SUI in CrossFit and functional fitness exercisers. At baseline, a pelvic floor muscle assessment (resting pressure, strength and endurance) will be performed of all participants. In addition, the participants will respond to an electronic questionnaire, measuring self-reported symptoms of UI and bother. The participants will be randomly assigned to either a PFM training group (EG) or a control group (CG) with no intervention. The intervention consists of a daily home-based PFM training program with weekly follow-up by a physiotherapist. After a 16-week intervention period, all participants will perform a post-test including the same previous mentioned outcome measures.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Other: Pelvic Floor Muscle Training in female CrossFit and functional fitness exercisers16 weeks home-based PFM training program with weekly follow-up by a physiotherapist |
| Control Group | No intervention | –No intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age ≥18
- ≥ 6 months of consistent participation in CrossFit or functional fitness training
- Participating in ≥ 3 sessions of cross-fit training per week
- Self-reported SUI and a total score on ICIQ-UI-SF of ≥ 3. A change of the ICIQ-UI-SF score of 2.5 has been identified to be the minimal important difference (MID) and 1.58 as between-treatment MID (Nystrom et al., 2015).
- No musculoskeletal injuries for the past 6 months with negative effect on training participation
Key exclusion criteria (4 listed)
- Ongoing pregnancy, or planning to get pregnant during the intervention period
- History of hysterectomy or pelvic surgery to correct UI or POP
- History of musculoskeletal injuries for the past 6 months with negative effect on training participation
- Parous women who are ≤12 months post-partum
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 |
|---|---|---|
| Pelvic Floor Muscle Training in female CrossFit and functional fitness exercisersThe intervention will consist of a home-based PFM training program with weekly follow-up by phone by a physiotherapist. Before commencing PFM training, the participants in the intervention group will have an individual session with a physiotherapist including thorough teaching on how to perform a correct PFM contraction (clinical exams of pelvic floor muscle function by observation and vaginal digital palpation) and instructions on how to perform the training program. The program consists of 3 sets of 8-12 maximum contractions per day. An electronic app (Athlete monitoring) will be used to assess adherence to the program. The participants will be asked to register their training sessions in a personal account. A reminder to adhere to the program will be sent by phone. The training period will be 16 weeks and the exercises will take approximately 10 minutes per day to perform. | Other | Intervention Group |
Primary outcome
The International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI-SF)
Time frame: Change in total score from baseline at four months
A reliable and valid questionnaire assessing self-reported prevalence, amount of leakage, bother and type of UI. A change in ICIQ-UI-SF score of 1.58 points will be considered as between-treatment minimum important difference.
7 secondary outcomes
Pelvic Floor Muscle Resting Pressure
Time frame: Change in pressure value from baseline at four months
Pelvic Floor Muscle Strength
Time frame: Change in pressure value from baseline at four months
Pelvic Floor Muscle Endurance
Time frame: Change in pressure value from baseline at four months
Self-Efficacy Scale for Practicing Pelvic Floor Exercises (SESPPFE)
Time frame: At baseline in both groups. Participants in the intervention group will also be asked to answer the questionnaire again within the first month of the intervention period
Anal incontinence
Time frame: Change in score from baseline at four months
Pelvic Organ Prolapse
Time frame: Change in score from baseline at four months
Patient Global Impression of Improvement (PGI-I) Scale
Time frame: Post-test after a 4-months intervention period
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2024.
- Background: PubMed 30571339Piercy KL, Troiano RP. Physical Activity Guidelines for Americans From the US Department of Health and Human Services. Circ Cardiovasc Qual Outcomes. 2018 Nov;11(11):e005263. doi: 10.1161/CIRCOUTCOMES.118.005263. No abstract available.
- BackgroundRuiz-Zapata, A. M., Feola, A. J., Heesakkers, J., de Graaf, P., Blaganje, M., & Sievert, K. D. (2018). Biomechanical Properties of the Pelvic Floor and its Relation to Pelvic Floor Disorders. European Urology Supplements, 17(3), 80-90.
- Background: PubMed 9921553Bump RC, Norton PA. Epidemiology and natural history of pelvic floor dysfunction. Obstet Gynecol Clin North Am. 1998 Dec;25(4):723-46. doi: 10.1016/s0889-8545(05)70039-5.
- BackgroundMilsom, I., Altman, D., Cartwright, R., Lapitan, M. C. M., Nelson, R., Sjöström, S., & Tikkinen, K. A. O. (2017). Epidemiology of urinary incontinence (UI) and other lower urinary tract symptoms (LUTS), pelvic organ prolapse (POP) and anal (AI) incontinence. In P. C. Abrams, L.; Wagg, A.; Wein, A. (Ed.), Incontinence (Vol. 1, pp. 1-141). Tokyo: 6th International Consultation on Incontinence.
- Background: PubMed 19937315Haylen BT, de Ridder D, Freeman RM, Swift SE, Berghmans B, Lee J, Monga A, Petri E, Rizk DE, Sand PK, Schaer GN. An International Urogynecological Association (IUGA)/International Continence Society (ICS) joint report on the terminology for female pelvic floor dysfunction. Int Urogynecol J. 2010 Jan;21(1):5-26. doi: 10.1007/s00192-009-0976-9. Epub 2009 Nov 25.
- BackgroundBø, K. (2015). Pelvic floor dysfunction, prevention and treatment in elite athletes. In K. Bø, B. Berghmans, S. Mørkved, & M. Van Kampen (Eds.), Evidence based Physical Therapy for the Pelvic Floor - Bridging science and clinical practice (pp. 397-407). Edinburgh London New York Oxford Philadelphia St Louis Sydney Toronto: Elsevier Churchilll Livingstone.
- Background: PubMed 29552736de Mattos Lourenco TR, Matsuoka PK, Baracat EC, Haddad JM. Urinary incontinence in female athletes: a systematic review. Int Urogynecol J. 2018 Dec;29(12):1757-1763. doi: 10.1007/s00192-018-3629-z. Epub 2018 Mar 19.
- Background: PubMed 26348380Nygaard IE, Shaw JM. Physical activity and the pelvic floor. Am J Obstet Gynecol. 2016 Feb;214(2):164-171. doi: 10.1016/j.ajog.2015.08.067. Epub 2015 Sep 6.
- Background: PubMed 21571270Jacome C, Oliveira D, Marques A, Sa-Couto P. Prevalence and impact of urinary incontinence among female athletes. Int J Gynaecol Obstet. 2011 Jul;114(1):60-3. doi: 10.1016/j.ijgo.2011.02.004. Epub 2011 May 14.
- Background: PubMed 8041527Nygaard IE, Thompson FL, Svengalis SL, Albright JP. Urinary incontinence in elite nulliparous athletes. Obstet Gynecol. 1994 Aug;84(2):183-7.
- Background: PubMed 25713669Poswiata A, Socha T, Opara J. Prevalence of stress urinary incontinence in elite female endurance athletes. J Hum Kinet. 2014 Dec 30;44:91-6. doi: 10.2478/hukin-2014-0114. eCollection 2014 Dec 9.
- Background: PubMed 18224267Eliasson K, Edner A, Mattsson E. Urinary incontinence in very young and mostly nulliparous women with a history of regular organised high-impact trampoline training: occurrence and risk factors. Int Urogynecol J Pelvic Floor Dysfunct. 2008 May;19(5):687-96. doi: 10.1007/s00192-007-0508-4. Epub 2008 Jan 26.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Kari Bø, PhD study chair
Norwegian School of School of Sport Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pelvic Floor Muscle Training in female CrossFit and functional fitness exercisers in people with Stress Urinary Incontinence and Pelvic Floor Disorders, run by Norwegian School of Sport Sciences at 1 site in Norway.
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 5 inclusion and 4 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: finished, as of the sponsor's last update on 22 Mar 2024. 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 Norway. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI-SF) (time frame: Change in total score from baseline at four months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05341024, which also lists 36 linked publications.
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 22 Mar 2024.