Ignite Creation Date:
2024-05-05 @ 11:52 AM
Last Modification Date:
2024-10-26 @ 9:15 AM
Study NCT ID:
NCT00158626
Status:
COMPLETED
Last Update Posted:
2015-03-19
First Post:
2005-09-08
Brief Title:
Does Doing Pelvic Floor Exercise Ease Symptoms for Women Living With Prolapse
Sponsor:
Glasgow Caledonian University
Organization:
Glasgow Caledonian University
Study Overview
Official Title:
A Feasibility Study for an RCT of a Pelvic Floor Muscle Training Intervention for Pelvic Organ Prolapse
Status:
COMPLETED
Status Verified Date:
2015-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to investigate the feasibility of undertaking a multi-centre randomised controlled trial of the effectiveness of a pelvic floor muscle training PFMT intervention for women with pelvic organ prolapse
Detailed Description:
Pelvic organ prolapse is a common female condition it is estimated that 50 of women experience some degree of prolapse and 30 of attendees at gynaecology clinics present with this problem Vaginal delivery is cited as the main cause of prolapse but menopause heavy lifting chronic cough and straining are also important factors Symptoms associated with prolapse are backache pelvic heaviness and bladder bowel and sexual dysfunction Thus the condition is debilitating and can greatly affect the sufferers daily activities and quality of life
Traditionally treatment of prolapse consists of surgery or conservative treatment Surgical procedures to repair the fascia vary and improved techniques are constantly being sought At present however the recurrence rate of prolapse after surgery is 25 with 80 re-occurring within two years of surgery Conservative treatment is often considered if the prolapse is small or the patient is not a good candidate for surgery There are three types of conservative treatment 1 Physical interventions that aim to improve pelvic floor muscle function by using pelvic floor muscle assessment and exercises neuromuscular electrical stimulation 2 Mechanical interventions that aim to manage the prolapse by supporting the pelvic area eg using vaginal ring pessaries and 3 Lifestyle interventions such as weight loss and reducing exacerbating activities that seek to avoid exacerbation of the prolapse by decreasing intra-abdominal pressure
The promotion of pelvic floor exercises PFEs for prolapse varies between hospitals with some providing only a patient information leaflet and others giving individual instruction from a physiotherapist Such a programme is referred to as pelvic floor muscle training PFMT An ongoing Cochrane review of the literature has to date found no evidence for management of pelvic organ prolapse using PFMT This proposal addresses a gap in the research evidence by developing a multi-centre randomised controlled trial of a PFMT intervention for women with prolapse The feasibility of all aspects of such a trial will be assessed and pilot data will be collected at two Scottish Centres Glasgow and Aberdeen Ultimately a multi-centre trial would aim to establish if PFMT is better than standardised management for reducing prolapse specific symptoms prolapse severity the need for surgical prolapse repair and the costs associated with the condition
50 women attending out-patient clinics who are suitable for the study will be randomised to either the control or intervention arm of the trial Women in the intervention arm will receive an individualised programme of PFMT delivered by a physiotherapist via 5 sessions of physiotherapy over a 16 week period This programme will include pelvic muscle assessment teaching and prescription of pelvic floor exercises and provision of lifestyle advice Women in the control arm will only receive by post a lifestyle advice leaflet Type and severity of prolapse will be quantified according to ICS guidelines POP-Q method Data on outcome measures relating to improvement in prolapse symptoms and associated quality of life will be obtained via self-completion questionnaires
Traditionally treatment of prolapse consists of surgery or conservative treatment Surgical procedures to repair the fascia vary and improved techniques are constantly being sought At present however the recurrence rate of prolapse after surgery is 25 with 80 re-occurring within two years of surgery Conservative treatment is often considered if the prolapse is small or the patient is not a good candidate for surgery There are three types of conservative treatment 1 Physical interventions that aim to improve pelvic floor muscle function by using pelvic floor muscle assessment and exercises neuromuscular electrical stimulation 2 Mechanical interventions that aim to manage the prolapse by supporting the pelvic area eg using vaginal ring pessaries and 3 Lifestyle interventions such as weight loss and reducing exacerbating activities that seek to avoid exacerbation of the prolapse by decreasing intra-abdominal pressure
The promotion of pelvic floor exercises PFEs for prolapse varies between hospitals with some providing only a patient information leaflet and others giving individual instruction from a physiotherapist Such a programme is referred to as pelvic floor muscle training PFMT An ongoing Cochrane review of the literature has to date found no evidence for management of pelvic organ prolapse using PFMT This proposal addresses a gap in the research evidence by developing a multi-centre randomised controlled trial of a PFMT intervention for women with prolapse The feasibility of all aspects of such a trial will be assessed and pilot data will be collected at two Scottish Centres Glasgow and Aberdeen Ultimately a multi-centre trial would aim to establish if PFMT is better than standardised management for reducing prolapse specific symptoms prolapse severity the need for surgical prolapse repair and the costs associated with the condition
50 women attending out-patient clinics who are suitable for the study will be randomised to either the control or intervention arm of the trial Women in the intervention arm will receive an individualised programme of PFMT delivered by a physiotherapist via 5 sessions of physiotherapy over a 16 week period This programme will include pelvic muscle assessment teaching and prescription of pelvic floor exercises and provision of lifestyle advice Women in the control arm will only receive by post a lifestyle advice leaflet Type and severity of prolapse will be quantified according to ICS guidelines POP-Q method Data on outcome measures relating to improvement in prolapse symptoms and associated quality of life will be obtained via self-completion questionnaires
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| ISRCTN44995705 | None | None | None |
| NRR N0470119684 | None | None | None |