Urinary IncontinencePOsITIveNCT03986411
Physiotherapy to Treat Urinary Incontinence in Athletes
A study testing Phase 1: Qualitative interviews: Health care professionals, Phase 2: Physiotherapy for urinary incontinence and Phase 3: Qualitative Interviews: Participants in people with Urinary Incontinence, run by University of Nottingham at 1 site in United Kingdom.
Trial summary
Nearly half of all adult women suffer with Urinary incontinence (UI), this is more common in athletes. UI is considered to be due to weak pelvic floor muscles. Standard advice encourages strength and endurance training; however, assessment of pelvic floor muscles can sometimes reveal overactive or tight tissues. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Urinary Incontinence
- What is being tested?
- Phase 1: Qualitative interviews: Health care professionals, Phase 2: Physiotherapy for urinary incontinence and Phase 3: Qualitative Interviews: Participants
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 27 Aug 2019to 3 Dec 2020
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Phase 1: Qualified local Health Care Professional eg G.P., nurse or chartered physiotherapist working within Nottinghamshire or Derbyshire
- Phases 2 and 3:Adult female Currently exercising for a minimum 3 times a week and for over 150 minutes per week Self-reported experience of symptoms of UI defined as; leaking of urine associated with increased abdominal pressure e.g. impact, leaking of urine associated with urinary urge, increased urinary urge and/or increased urinary frequency
Who cannot join
- Phase 1: Unwilling or unable to provide written informed consent Not within Nottinghamshire or Derbyshire area
- Phases 2 and 3: Under 18 Sports participation less than 1 year Pregnancy Less than one year after childbirth Ongoing physiotherapy or continence advice treatment elsewhere or within the last year De novo oestrogen or anticholinergic treatment Existing neurological conditions that may contribute to UI eg multiple sclerosis, stroke, spinal injury etc Unwilling or unable to provide written informed consent Unable to read or speak English
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
University of Nottingham
Nottingham, Nottinghamshire, NG7 2UH
About this study
Official title: Physiotherapy Management of Urinary Incontinence in Athletic Women- A Feasibility Study
Nearly half of all adult women suffer with Urinary incontinence (UI), this is more common in athletes.
UI is considered to be due to weak pelvic floor muscles. Standard advice encourages strength and endurance training; however, assessment of pelvic floor muscles can sometimes reveal overactive or tight tissues.
Read more
Evidence suggests athletes have stronger pelvic floors than non-athletes. If the pelvic floor is overactive, general advice regarding pelvic floor strengthening will not improve UI, and may make it worse.
This study will explore the feasibility of conducting a larger trial to identify cost effectiveness and benefits of treating athletes with physiotherapy and how this might differ from current practice.
15 -20 athletic women will complete questionnaires regarding their UI and its effects on them. They will receive physiotherapy; the assessment will include a history and internal examination of their pelvic floor. This will inform a tailored rehabilitation program.
Interviews will be conducted with some of these women to explore their response to the intervention. Interviews with health professionals will establish current practice for this patient group.
The results will tell us how likely it is for athletes to volunteer and take part in a future study and which outcomes are useful.
Read the detailed description
Aims: The investigator's overall purpose is to conduct an RCT to determine whether one to one physiotherapy can improve the symptoms of urinary incontinence (UI) in a group of athletic women. This feasibility study will enable us to ascertain the viability of conducting a definitive appropriately powered trial.
Research protocol: The research design is a mixed methods study with three distinct but related phases.
Phase 1: 6-8 local health care professionals (GPs, nurses and physiotherapists) will be recruited for interview to explore current management practices of urinary incontinence (UI) in primary care.
Phase 2: 15-20 sporting or athletic women who self- report symptoms of UI will be recruited from the local sporting community. Each will undergo individual subjective and objective assessments in order to establish history, symptoms and pelvic floor muscle function. The intervention will be then be tailored from these assessments and agreed between each individual and the specialist physiotherapist. It will include guided exercise within the clinic and a regular home exercise plan, in keeping with typical pelvic health regimes for pelvic floor muscle (PFM) dysfunction.
Phase 3: 6-8 participants from phase 2 will be invited to take part in a qualitative interview in order to gain more in-depth understanding of UI. Purposeful selection will account for age, sporting activity and severity of symptoms. The interviews will be to explore the effects of UI on their quality of life, their participation in sport and exercise and the acceptability of the intervention.
Measurable end points: 6 months from recruitment of the last participant in phase 2 will be considered to be the end point of the study.
- Conditions
- Urinary Incontinence
- Being tested
- Phase 1: Qualitative interviews: Health care professionals, Phase 2: Physiotherapy for urinary incontinence, Phase 3: Qualitative Interviews: Participants
- Keywords
- urinary incontinence, pelvic floor, athlete
- Medical subject headings
- Urinary Incontinence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Phase 1: Qualitative interviews: Health care professionalsOther
Semi-structured interviews of health care professionals to explore current management of urinary incontinence in the community
Phase 2: Physiotherapy for urinary incontinenceOther
Tailored physiotherapy assessment and management for athletic women who self-report urinary incontinence
Phase 3: Qualitative Interviews: ParticipantsOther
Semi-structured interviews of a purposeful selection of the participants from Phase 2 to explore reaction to the recruitment process and the intervention
| Study group | Role | What they receive |
|---|---|---|
| Feasibility study of physiotherapy for UI in athletic women | Other | A mixed methods study with 3 distinct but related phases to explore the feasibility of conducting an RCT of physiotherapy as management of urinary incontinence in athletic women Receives: Other: Phase 1: Qualitative interviews: Health care professionals; Other: Phase 2: Physiotherapy for urinary incontinence; Other: Phase 3: Qualitative Interviews: Participants |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment rate
Ease of recruiting participants directly from gyms and sports clubs
Measured: Up to 8 Months
Attrition rate
The number of participants who consent to participate that remain in the study
Measured: 6 months after the participant's first assessment
Acceptability of the intervention: % that give positive feedback from the interviews
Measured as the % that give positive feedback from the interviews in Phase 3
Measured: Up to 9 months
Acceptability of the secondary outcome measures used in Phase 2: % positive feedback for each outcome measure from the interviews
Measured as the % positive feedback for each outcome measure from the interviews in Phase 3
Measured: Up to 9 months
Timescale required for intervention
The time required for a successful intervention. This will be measured by the change in the secondary outcome measures between the three month assessment and the six months assessment
Measured: Six months for each participant from the first assessment
Secondary outcomes (2)
Urinary Distress Inventory (UDI) 6
A short questionnaire to evaluate 'bother' of urinary symptoms (6 questions) mean score x 33.3 to give a final score out of 100. Where 100 indicates the most severe urinary distress
Measured: Six months from the first assessment for each participant
International Consultation on Incontinence Modular Questionnaire Female Lower Urinary Tract Symptoms Long Form Module (ICIQ-FLUTS-LF)
A long quality of life and descriptive questionnaire to establish type and severity of urinary symptoms and the impact of these on quality of life (Two scores: urinary symptoms max score 69 where this is indicates the most severe; quality of life score, where the maximum score is 150, where urinary symptoms are having the maximum negative impact on quality of life
Measured: Six months from the first assessment for each participant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2019
- Study start27 Aug 2019
- Primary completion3 Dec 2020
- Study completion3 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Urinary IncontinenceStudies of the same condition, open and under way.
- More trials run by University of NottinghamThe 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
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Mixed methods feasibility study. Three phases: Phase 1: Interviews Health car professionals, Phase 2: Intervention, Phase 3: Interviews of Participants
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nottingham
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gillian Campbell, BVMS BSc PhD, Principal investigator, University of Nottingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03986411
- Sponsor's protocol ID
- A2RMUR
- Acronym
- POsITIve
- Status last verified
- Nov 2020
- First submitted
- 10 Jun 2019
- Last updated
- 1 Jun 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Anonymised data may be made available to other researchers at the end of the study
Publications
Campbell KG, Nouri F, E Batt M, Drummond A. Management of urinary incontinence in athletic women: the POsITIve feasibility study. Physiotherapy. 2022 Mar;114:30-37. doi: 10.1016/j.physio.2021.12.001. Epub 2021 Dec 18.
PubMed 35101711Campbell KG, Batt ME, Drummond A. A feasibility study of the physiotherapy management of urinary incontinence in athletic women: trial protocol for the POsITIve study. Pilot Feasibility Stud. 2020 Jul 16;6:103. doi: 10.1186/s40814-020-00638-6. eCollection 2020.
PubMed 32695435
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physiotherapy Management of Urinary Incontinence in Athletic Women- A Feasibility Study
- ClinicalTrials.gov ID
- NCT03986411
- Acronym / sponsor ID
- POsITIve / A2RMUR
- Conditions
- Urinary Incontinence
- Keywords
- urinary incontinence, pelvic floor, athlete
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- University of NottinghamUniversity, hospital or other
- Study start
- 27 Aug 2019 (actual)
- Primary completion
- 3 Dec 2020 (actual)
- Study completion
- 3 Dec 2020 (actual)
- First posted
- 14 Jun 2019 (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.
Nearly half of all adult women suffer with Urinary incontinence (UI), this is more common in athletes.
UI is considered to be due to weak pelvic floor muscles. Standard advice encourages strength and endurance training; however, assessment of pelvic floor muscles can sometimes reveal overactive or tight tissues.
Evidence suggests athletes have stronger pelvic floors than non-athletes. If the pelvic floor is overactive, general advice regarding pelvic floor strengthening will not improve UI, and may make it worse.
This study will explore the feasibility of conducting a larger trial to identify cost effectiveness and benefits of treating athletes with physiotherapy and how this might differ from current practice.
15 -20 athletic women will complete questionnaires regarding their UI and its effects on them. They will receive physiotherapy; the assessment will include a history and internal examination of their pelvic floor. This will inform a tailored rehabilitation program.
Interviews will be conducted with some of these women to explore their response to the intervention. Interviews with health professionals will establish current practice for this patient group.
The results will tell us how likely it is for athletes to volunteer and take part in a future study and which outcomes are useful.
Detailed description
Aims: The investigator's overall purpose is to conduct an RCT to determine whether one to one physiotherapy can improve the symptoms of urinary incontinence (UI) in a group of athletic women. This feasibility study will enable us to ascertain the viability of conducting a definitive appropriately powered trial.
Research protocol: The research design is a mixed methods study with three distinct but related phases.
Phase 1: 6-8 local health care professionals (GPs, nurses and physiotherapists) will be recruited for interview to explore current management practices of urinary incontinence (UI) in primary care.
Phase 2: 15-20 sporting or athletic women who self- report symptoms of UI will be recruited from the local sporting community. Each will undergo individual subjective and objective assessments in order to establish history, symptoms and pelvic floor muscle function. The intervention will be then be tailored from these assessments and agreed between each individual and the specialist physiotherapist. It will include guided exercise within the clinic and a regular home exercise plan, in keeping with typical pelvic health regimes for pelvic floor muscle (PFM) dysfunction.
Phase 3: 6-8 participants from phase 2 will be invited to take part in a qualitative interview in order to gain more in-depth understanding of UI. Purposeful selection will account for age, sporting activity and severity of symptoms. The interviews will be to explore the effects of UI on their quality of life, their participation in sport and exercise and the acceptability of the intervention.
Measurable end points: 6 months from recruitment of the last participant in phase 2 will be considered to be the end point of the study.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Mixed methods feasibility study. Three phases: Phase 1: Interviews Health car professionals, Phase 2: Intervention, Phase 3: Interviews of Participants
| Arm | Type | Receives |
|---|---|---|
| Feasibility study of physiotherapy for UI in athletic women | Other | Other: Phase 1: Qualitative interviews: Health care professionals, Other: Phase 2: Physiotherapy for urinary incontinence, Other: Phase 3: Qualitative Interviews: ParticipantsA mixed methods study with 3 distinct but related phases to explore the feasibility of conducting an RCT of physiotherapy as management of urinary incontinence in athletic women |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Phase 1: Qualified local Health Care Professional eg G.P., nurse or chartered physiotherapist working within Nottinghamshire or Derbyshire
- Phases 2 and 3:Adult female Currently exercising for a minimum 3 times a week and for over 150 minutes per week Self-reported experience of symptoms of UI defined as; leaking of urine associated with increased abdominal pressure e.g. impact, leaking of urine associated with urinary urge, increased urinary urge and/or increased urinary frequency
Key exclusion criteria (2 listed)
- Phase 1: Unwilling or unable to provide written informed consent Not within Nottinghamshire or Derbyshire area
- Phases 2 and 3: Under 18 Sports participation less than 1 year Pregnancy Less than one year after childbirth Ongoing physiotherapy or continence advice treatment elsewhere or within the last year De novo oestrogen or anticholinergic treatment Existing neurological conditions that may contribute to UI eg multiple sclerosis, stroke, spinal injury etc Unwilling or unable to provide written informed consent Unable to read or speak English
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 |
|---|---|---|
| Phase 1: Qualitative interviews: Health care professionalsSemi-structured interviews of health care professionals to explore current management of urinary incontinence in the community | Other | Feasibility study of physiotherapy for UI in athletic women |
| Phase 2: Physiotherapy for urinary incontinenceTailored physiotherapy assessment and management for athletic women who self-report urinary incontinence | Other | Feasibility study of physiotherapy for UI in athletic women |
| Phase 3: Qualitative Interviews: ParticipantsSemi-structured interviews of a purposeful selection of the participants from Phase 2 to explore reaction to the recruitment process and the intervention | Other | Feasibility study of physiotherapy for UI in athletic women |
Primary outcome
Recruitment rate
Time frame: Up to 8 Months
Ease of recruiting participants directly from gyms and sports clubs
Attrition rate
Time frame: 6 months after the participant's first assessment
The number of participants who consent to participate that remain in the study
Acceptability of the intervention: % that give positive feedback from the interviews
Time frame: Up to 9 months
Measured as the % that give positive feedback from the interviews in Phase 3
Acceptability of the secondary outcome measures used in Phase 2: % positive feedback for each outcome measure from the interviews
Time frame: Up to 9 months
Measured as the % positive feedback for each outcome measure from the interviews in Phase 3
Timescale required for intervention
Time frame: Six months for each participant from the first assessment
The time required for a successful intervention. This will be measured by the change in the secondary outcome measures between the three month assessment and the six months assessment
2 secondary outcomes
Urinary Distress Inventory (UDI) 6
Time frame: Six months from the first assessment for each participant
International Consultation on Incontinence Modular Questionnaire Female Lower Urinary Tract Symptoms Long Form Module (ICIQ-FLUTS-LF)
Time frame: Six months from the first assessment for each participant
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 1 Jun 2023.
- Derived from this study: PubMed 35101711Campbell KG, Nouri F, E Batt M, Drummond A. Management of urinary incontinence in athletic women: the POsITIve feasibility study. Physiotherapy. 2022 Mar;114:30-37. doi: 10.1016/j.physio.2021.12.001. Epub 2021 Dec 18.
- Derived from this study: PubMed 32695435Campbell KG, Batt ME, Drummond A. A feasibility study of the physiotherapy management of urinary incontinence in athletic women: trial protocol for the POsITIve study. Pilot Feasibility Stud. 2020 Jul 16;6:103. doi: 10.1186/s40814-020-00638-6. eCollection 2020.
- Individual participant dataSharing planned: Yes. Anonymised data may be made available to other researchers at the end of the study
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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.
Gillian Campbell, BVMS BSc PhD principal investigator
University of Nottingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Phase 1: Qualitative interviews: Health care professionals, Phase 2: Physiotherapy for urinary incontinence and Phase 3: Qualitative Interviews: Participants in people with Urinary Incontinence, run by University of Nottingham at 1 site in United Kingdom.
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 2 inclusion and 2 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 1 Jun 2023. 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 United Kingdom. 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?
Recruitment rate (time frame: Up to 8 Months). The study lists 5 primary outcomes in all. 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 NCT03986411, which also lists 2 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 1 Jun 2023.