An interventional study of Pelvic Floor Muscle training in Pelvic Organ Prolapse, Uterine Prolapse and Anterior Wall; Prolapse, Vaginal, sponsored by University of Salford. Status unknown at 1 site in United Kingdom. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-07-09.
Sponsored by University of Salford · Not applicable, Interventional, and Treatment
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.
521 studies on the registry are indexed under Pelvic Organ Prolapse; 80 are open to participants now.
This study's planned enrollment of 60 is below the median of 80 across 336 interventional studies indexed under Pelvic Organ Prolapse.
Browse Pelvic Organ Prolapse studies →University of Salford is the lead sponsor of 27 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
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.
Other: Pelvic Floor Muscle training
Sixteen weeks of supervised pelvic floor muscle training with a specialist physiotherapist
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.
Time frame: sixteen weeks
Plan to share: Yes
No publications or documents are linked to this record.
Started Sep 2018 (actual). Primary completion is estimated for Sep 2019, 12 months after the start.
Of 162 non-industry interventional studies with no phase under Pelvic Organ Prolapse, half reached primary completion within 22 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 43. This study's planned 12 months is below that.
Counting every sponsor, half of 179 studies reached it within 23 months; a quarter within 12 and three quarters within 48.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Jul 2019. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
University of Salford