Pelvic Organ ProlapseNCT04009694
Does a High BMI Affect Supervised Pelvic Floor Muscle Training for Improving Symptoms in Women With Various Stages of Pelvic Organ Prolapse?
A study testing Pelvic Floor Muscle training in people with Pelvic Organ Prolapse and Uterine Prolapse, run by University of Salford at 1 site in United Kingdom.
Trial summary
The trial design is a quasi-experimental cohort trial that includes women referred for pelvic organ prolapse specific physiotherapy. Candidates will be selected via a convenience sampling method from four physiotherapy outpatient departments at a NHS trust within Greater Manchester. 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
- Pelvic Organ Prolapse, Uterine Prolapse, Anterior Wall; Prolapse, Vaginal
- What is being tested?
- Pelvic Floor Muscle training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Sep 2018to 10 Sep 2019
- 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
- Gynaecologist diagnosed women with a mild / moderate or severe pelvic organ prolapse
- >18 years old
Who cannot join
- Unwilling or unable to provide informed consent (opt out of treatment)
- Unable to contract the pelvic floor muscles (determined by the treating physiotherapist)
- History of Pelvic cancer / or radiotherapy treatment within three months,
- Neurological or psychiatric disorders,
- Untreated urinary tract infections,
- Pregnant or planning to become pregnant or given birth within the past year,
- Recent vaginal surgery within twelve weeks or evidence of genital oedema,
- Suspected infection or fragility of the genital area As indicated by the referral source or patient reported at the initial assessment.
Trial locations and contacts
1 site in 1 country.
Nicky Spence, PhD contact
United Kingdom1 site, 1 recruiting
- Recruiting
National Health Service
Manchester, M8 5RB
Rebecca C Whittle, MSc, 0161 720 2423, R.Hadfield1@edu.salford.ac.uk
About this study
The trial design is a quasi-experimental cohort trial that includes women referred for pelvic organ prolapse specific physiotherapy.
Candidates will be selected via a convenience sampling method from four physiotherapy outpatient departments at a NHS trust within Greater Manchester. The data collection occurred in January-June 2019 and ethical approval was granted by School Research Ethics, University of Salford.
Read more
Treatment aims to ensure there is respect for their autonomy, treatment is fair (Justice), no harm is done to the participant (nonmaleficence) and treatment benefits the participants (beneficence).
Participants are required to complete a consent form prior to their initial session. To ensure methodological quality, the STROBE guidelines will be followed to make certain all apt information required is reported to allow for replication of the intervention.
The trial aims to include (n=60) women with a diagnosed pelvic organ prolapse. They are required to complete 16 weeks of supervised pelvic floor exercises with a specialist physiotherapist as documented within the most recent NICE guidelines.
The outcome measures used will be the Pelvic Organ Prolapse symptom score (POPSS) and this will be documented before and after the 16 week period.
Along side the POPSS, the patients body mass index and severity of pelvic organ prolapse will also be recorded and the results of this will be correlated post trial using the relevant data analysis testing methods.
- Conditions
- Pelvic Organ Prolapse, Uterine Prolapse, Anterior Wall; Prolapse, Vaginal, Posterior Wall; Prolapse, Vaginal, Cystocele, Rectocele
- Being tested
- Pelvic Floor Muscle training
- Keywords
- Pelvic floor muscle training, pelvic physiotherapy, pelvic floor exercises
- Medical subject headings
- Pelvic Organ Prolapse, Uterine Prolapse, Prolapse, Cystocele, Rectocele
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pelvic Floor Muscle trainingOther
Sixteen weeks of supervised pelvic floor muscle training with a specialist physiotherapist
| Study group | Role | What they receive |
|---|---|---|
| Pelvic Floor Muscle Training | Experimental | Sixteen weeks of supervised pelvic floor muscle training with a specialist physiotherapist.
Participants will be assessed at weeks 0 / 4 / 10 \& 16 and the outcome measures will be recorded at week 0 \& week 16.
During each assessment, participants will be educated regarding the anatomy of pelvic organ prolapses and the pelvic floor muscles. They will be taught how to contract their pelvic floor, offered a vaginal examination, given a personalised pelvic floor muscle training programme (including the Knack) - up to a ten second hold long contractions (x 10 repitations) and up to 10 quick contractions. They will also be taught a sub max contraction for up to 30 seconds, offered lifestyle management advice including avoiding heavy lifting or straining. A leaflet explaining the aforementioned information will also be provided at the initial assessment. Receives: Other: Pelvic Floor Muscle training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pelvic Organ Prolapse Symptom Score (POPSS)
The POPSS is a patient-reported Outcome Measure consisting of seven POP symptom specific items, each with a five-point Likert response set (0 = never, 1 = occasionally, 2 = sometimes, 3 = most of the time and 4 = all of the time). The minimum score is 0 which would indicate that the pelvic organ prolapse in a-symptomatic and the maximum score for the POPSS is 28 which would indicate higher severity in pelvic organ prolapse symptoms. In addition, the women select a specific symptom which is most bothersome for them.
Measured: sixteen weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2019
- Study start1 Sep 2018
- Primary completion1 Sep 2019 (estimated)
- Study completion10 Sep 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pelvic Organ ProlapseStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Salford
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rebecca Whittle, University of Salford
- Investigators
- Nicky Spence, PhD, Study chair, University of Salford
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04009694
- Sponsor's protocol ID
- USalford1
- Status last verified
- Jul 2019
- First submitted
- 2 Jul 2019
- Last updated
- 9 Jul 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does a High BMI Affect Supervised Pelvic Floor Muscle Training for Improving Symptoms in Women With Various Stages of Pelvic Organ Prolapse?
- ClinicalTrials.gov ID
- NCT04009694
- Acronym / sponsor ID
- USalford1
- Conditions
- Pelvic Organ Prolapse, Uterine Prolapse, Anterior Wall; Prolapse, Vaginal, Posterior Wall; Prolapse, Vaginal, Cystocele, Rectocele
- Keywords
- Pelvic floor muscle training, pelvic physiotherapy, pelvic floor exercises
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of SalfordUniversity, hospital or other
- Study start
- 1 Sep 2018 (actual)
- Primary completion
- 1 Sep 2019 (estimated)
- Study completion
- 10 Sep 2019 (estimated)
- First posted
- 5 Jul 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.
The trial design is a quasi-experimental cohort trial that includes women referred for pelvic organ prolapse specific physiotherapy.
Candidates will be selected via a convenience sampling method from four physiotherapy outpatient departments at a NHS trust within Greater Manchester. The data collection occurred in January-June 2019 and ethical approval was granted by School Research Ethics, University of Salford.
Treatment aims to ensure there is respect for their autonomy, treatment is fair (Justice), no harm is done to the participant (nonmaleficence) and treatment benefits the participants (beneficence).
Participants are required to complete a consent form prior to their initial session. To ensure methodological quality, the STROBE guidelines will be followed to make certain all apt information required is reported to allow for replication of the intervention.
The trial aims to include (n=60) women with a diagnosed pelvic organ prolapse. They are required to complete 16 weeks of supervised pelvic floor exercises with a specialist physiotherapist as documented within the most recent NICE guidelines.
The outcome measures used will be the Pelvic Organ Prolapse symptom score (POPSS) and this will be documented before and after the 16 week period.
Along side the POPSS, the patients body mass index and severity of pelvic organ prolapse will also be recorded and the results of this will be correlated post trial using the relevant data analysis testing methods.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pelvic Floor Muscle Training | Experimental | Other: Pelvic Floor Muscle trainingSixteen weeks of supervised pelvic floor muscle training with a specialist physiotherapist. Participants will be assessed at weeks 0 / 4 / 10 \& 16 and the outcome measures will be recorded at week 0 \& week 16. During each assessment, participants will be educated regarding the anatomy of pelvic organ prolapses and the pelvic floor muscles. They will be taught how to contract their pelvic floor, offered a vaginal examination, given a personalised pelvic floor muscle training programme (including the Knack) - up to a ten second hold long contractions (x 10 repitations) and up to 10 quick contractions. They will also be taught a sub max contraction for up to 30 seconds, offered lifestyle management advice including avoiding heavy lifting or straining. A leaflet explaining the aforementioned information will also be provided at the initial assessment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Gynaecologist diagnosed women with a mild / moderate or severe pelvic organ prolapse
- >18 years old
Key exclusion criteria (8 listed)
- Unwilling or unable to provide informed consent (opt out of treatment)
- Unable to contract the pelvic floor muscles (determined by the treating physiotherapist)
- History of Pelvic cancer / or radiotherapy treatment within three months,
- Neurological or psychiatric disorders,
- Untreated urinary tract infections,
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 trainingSixteen weeks of supervised pelvic floor muscle training with a specialist physiotherapist | Other | Pelvic Floor Muscle Training |
Primary outcome
Pelvic Organ Prolapse Symptom Score (POPSS)
Time frame: sixteen weeks
The POPSS is a patient-reported Outcome Measure consisting of seven POP symptom specific items, each with a five-point Likert response set (0 = never, 1 = occasionally, 2 = sometimes, 3 = most of the time and 4 = all of the time). The minimum score is 0 which would indicate that the pelvic organ prolapse in a-symptomatic and the maximum score for the POPSS is 28 which would indicate higher severity in pelvic organ prolapse symptoms. In addition, the women select a specific symptom which is most bothersome for them.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2019.
- Individual participant dataSharing planned: Yes
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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.
Nicky Spence, PhD contact
Nicky Spence, PhD study chair
University of Salford
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 people with Pelvic Organ Prolapse and Uterine Prolapse, run by University of Salford 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 8 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: status not confirmed, as of the sponsor's last update on 9 Jul 2019. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rebecca C Whittle, MSc (0161 7202423, R.Hadfield1@edu.salford.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pelvic Organ Prolapse Symptom Score (POPSS) (time frame: sixteen weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Jul 2019.