BehaviouralNCT01635894
A Community Intervention Study of Female Pelvic Floor Condition and Knowledge of Pelvic Floor Exercises
A study testing Training in people with Behavioural, run by University Hospital Plymouth NHS Trust at 1 site in United Kingdom.
Trial summary
The aims of the study were to attempt to answer the following questions; what proportion of women know how to and are able to exercise their pelvic floor and for those who cannot can they be trained and motivated to do so. 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
- Behavioural
- What is being tested?
- Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Apr 2002to Nov 2005
- 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
- Able to give consent Aged above 18 years modified Oxford score, MOS, ≤ 2
Who cannot join
- Unable to give consent
- -
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Plymouth Hospitals NHS Trust
Plymouth, Devon, PL6 8DH
About this study
The aims of the study were to attempt to answer the following questions; what proportion of women know how to and are able to exercise their pelvic floor and for those who cannot can they be trained and motivated to do so. This was a nested design comprising a prospective cohort study together with a controlled trial intervention after baseline assessment in the cohort study for a defined at-risk group.
- Conditions
- Behavioural
- Being tested
- Training
- Keywords
- female pelvic floor condition, pelvic floor training, supervised pelvic floor training, practice nurse, nurse specialist
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TrainingBehavioural
Also called Pelvic Floor Muscle Training (PFMT)
Women in both the practice nurse and specialist nurse groups were given supervised pelvic floor exercise training. After the initial training they were given a daily exercise regimen and seen at monthly intervals for three months. The practice nurses had attended a study day on supervising Pelvic Floor Muscle Training(PFMT)followed by practice sessions with patients overseen by the nurse specialist.
| Study group | Role | What they receive |
|---|---|---|
| nurse specialist | Experimental | Women were screened for a "weak pelvic floor" (modified Oxford score, MOS, ≤ 2) before being invited into the trial. The women were seen monthly after their initial assessment and training and were followed-up for their final assessment at 3 months. Receives: Behavioral: Training |
| practice nurse | Experimental | Women were screened for a "weak pelvic floor" (modified Oxford score, MOS, ≤ 2) before being invited into the trial. The women were seen monthly after their initial assessment and training and were followed-up for their final assessment at 3 months. Receives: Behavioral: Training |
| Control | No intervention | Women were screened for a "weak pelvic floor" (modified Oxford score, MOS, ≤ 2) before being invited into the trial. The women were seen monthly after their initial assessment (but no training given) and were followed-up for their final assessment at 3 months. |
What is being measured
The primary outcome is the main question the study is designed to answer.
maximal vaginal squeeze pressure (perineometry).
Measured: monthly for 3 months
Secondary outcomes (1)
endurance of contraction (perineometry)and digital vaginal palpation (MOS).
Measured: monthly for 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2012 (estimated)
- Study startApr 2002
- Primary completionNov 2005
- Study completionNov 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for BehaviouralStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 240 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Plymouth NHS Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Robert Freeman, MD, Principal investigator, University Hospital Plymouth NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01635894
- Sponsor's protocol ID
- 1706
- Other IDs
- WellBeing of Women
- Status last verified
- Nov 2015
- First submitted
- 3 Jul 2012
- Last updated
- 5 Nov 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Waterfield A, Waterfield M, Campbell J, Freeman R. Can effective supervised pelvic floor muscle training be provided by primary care nurses? A randomized controlled trial. Int Urogynecol J. 2021 Oct;32(10):2717-2725. doi: 10.1007/s00192-021-04692-3. Epub 2021 Feb 23.
PubMed 33624122
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Community Intervention Study of Female Pelvic Floor Condition and Knowledge of Pelvic Floor Exercises
- ClinicalTrials.gov ID
- NCT01635894
- Acronym / sponsor ID
- 1706
- Conditions
- Behavioural
- Keywords
- female pelvic floor condition, pelvic floor training, supervised pelvic floor training, practice nurse, nurse specialist
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 240 participants (actual)
- Lead sponsor
- University Hospital Plymouth NHS TrustUniversity, hospital or other
- Study start
- Apr 2002
- Primary completion
- Nov 2005 (actual)
- Study completion
- Nov 2005 (actual)
- First posted
- 10 Jul 2012 (estimated)
- 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.
The aims of the study were to attempt to answer the following questions; what proportion of women know how to and are able to exercise their pelvic floor and for those who cannot can they be trained and motivated to do so. This was a nested design comprising a prospective cohort study together with a controlled trial intervention after baseline assessment in the cohort study for a defined at-risk group.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| nurse specialist | Experimental | Behavioral: TrainingWomen were screened for a "weak pelvic floor" (modified Oxford score, MOS, ≤ 2) before being invited into the trial. The women were seen monthly after their initial assessment and training and were followed-up for their final assessment at 3 months. |
| practice nurse | Experimental | Behavioral: TrainingWomen were screened for a "weak pelvic floor" (modified Oxford score, MOS, ≤ 2) before being invited into the trial. The women were seen monthly after their initial assessment and training and were followed-up for their final assessment at 3 months. |
| Control | No intervention | –Women were screened for a "weak pelvic floor" (modified Oxford score, MOS, ≤ 2) before being invited into the trial. The women were seen monthly after their initial assessment (but no training given) and were followed-up for their final assessment at 3 months. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Able to give consent Aged above 18 years modified Oxford score, MOS, ≤ 2
Key exclusion criteria (2 listed)
- Unable to give consent
- -
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 |
|---|---|---|
| TrainingAlso: Pelvic Floor Muscle Training (PFMT)Women in both the practice nurse and specialist nurse groups were given supervised pelvic floor exercise training. After the initial training they were given a daily exercise regimen and seen at monthly intervals for three months. The practice nurses had attended a study day on supervising Pelvic Floor Muscle Training(PFMT)followed by practice sessions with patients overseen by the nurse specialist. | Behavioural | nurse specialist, practice nurse |
Primary outcome
maximal vaginal squeeze pressure (perineometry).
Time frame: monthly for 3 months
1 secondary outcome
endurance of contraction (perineometry)and digital vaginal palpation (MOS).
Time frame: monthly for 3 months
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 5 Nov 2015.
- Derived from this study: PubMed 33624122Waterfield A, Waterfield M, Campbell J, Freeman R. Can effective supervised pelvic floor muscle training be provided by primary care nurses? A randomized controlled trial. Int Urogynecol J. 2021 Oct;32(10):2717-2725. doi: 10.1007/s00192-021-04692-3. Epub 2021 Feb 23.
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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.
Robert Freeman, MD principal investigator
University Hospital Plymouth NHS Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Training in people with Behavioural, run by University Hospital Plymouth NHS Trust 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 1 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 5 Nov 2015. 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?
maximal vaginal squeeze pressure (perineometry). (time frame: monthly for 3 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 NCT01635894, which also lists 1 linked publication.
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 5 Nov 2015.