Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06532292
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-29
Brief Title:
Physical Therapy Intervention for Pelvic Organ Prolapses
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Physical Therapy Intervention for Pelvic Organ Prolapses
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Pelvic floor muscle training PFMT and pessaries are first-line non-surgical conservative treatments for pelvic organ prolapse POP High-Intensity Focused Electromagnetic Field HIFEM is a noninvasive and painless device designed to promote muscle strengthening and growth and has become a popular treatment option for urinary incontinence in the field of gynecology However HIFEM has not yet been rigorously compared to traditional physical therapy for POP The objectives of this pilot study are to explore clinical effects of HIFEM on POP symptoms to compare the effectiveness of HIFEM versus PFMT with biofeedback and usual care on patient-centered outcomes and to explore the acceptability of the interventions This is a prospective single-center randomized controlled trial with a nested qualitative interview study Twenty-one women with POP aged 20 years will be recruited and randomly allocated to three groups HIFEM group Biofeedback group and Usual care groupThe HIFEM group will be asked to sit straight in the center of an electromagnetic chair and remained fully clothed for 28 minutes The Biofeedback group will receive PFMT with biofeedback andor electrostimulation Both HIFEM and Biofeedback groups will receive the interventions twice a week for 8 weeks Participants allocated to the Usual care group will receive the lifestyle advice leaflet only All participants will be assessed for pelvic floor muscle function symptom severity of POP occurrence and distress related to pelvic floor dysfunction and impact of pelvic floor dysfunction at baseline and immediately post-intervention
Detailed Description:
Pelvic organ prolapse POP is a prevalent non-malignant condition affecting 30 to 50 women with roughly 30 of these women undergo surgical intervention due to related symptoms impacting their daily lives According to the international guidelines the management of POP encompasses several approaches including observation lifestyle adjustments pelvic floor muscle training PFMT the use of pessaries reconstructive surgeries obliterative surgeries transperineal surgeries and transabdominal surgeries Among these PFMT and pessaries are first-line non-surgical conservative treatments for POP High-Intensity Focused Electromagnetic Field HIFEM is a noninvasive and painless device designed to promote muscle strengthening and growth Recently the HIFEM has become a popular treatment option for urinary incontinence in the field of gynecology The HIFEM unlike traditional PFMT does not require any exposure of the intimate part of the body the patient is fully clothed and seated on the center of the chair during the treatment However while revolutionary HIFEM has not yet been rigorously compared to traditional physical therapy for POP
The objectives of this study are
1 To explore clinical effects of HIFEM on POP symptoms
2 To compare the effectiveness of HIFEM versus PFMT with biofeedback and usual care on patient-centered outcomes
3 To explore the acceptability of the interventions
This is a prospective single-center randomized controlled trial with a nested qualitative interview study Sixty-nine women with POP aged 20 years will be recruited and randomly allocated to three groups HIFEM group Biofeedback group and Usual care group The HIFEM group will be asked to sit straight in the center of an electromagnetic chair and remained fully clothed for 28 minutes The process will be supervised by a female physical therapist who will also provide a lifestyle advice leaflet and education to the participants The training will be provided at a frequency of two sessions per week over 8 weeks The Biofeedback group will receive PFMT with biofeedback andor electrostimulation twice a week for 8 weeks with a physical therapist Participants allocated to the Usual care group will receive the lifestyle advice leaflet only The baseline and immediately post-intervention assessments will include clinical examination of pelvic floor muscle function digital palpation and transperineal ultrasound and three questionnaires about symptom severity of POP occurrence and distress related to pelvic floor dysfunction and impact of pelvic floor dysfunction This study will provide evidence of effectiveness of different modes of physical therapy program for women with POP and health-care professionals working with this population in clinical practice
The objectives of this study are
1 To explore clinical effects of HIFEM on POP symptoms
2 To compare the effectiveness of HIFEM versus PFMT with biofeedback and usual care on patient-centered outcomes
3 To explore the acceptability of the interventions
This is a prospective single-center randomized controlled trial with a nested qualitative interview study Sixty-nine women with POP aged 20 years will be recruited and randomly allocated to three groups HIFEM group Biofeedback group and Usual care group The HIFEM group will be asked to sit straight in the center of an electromagnetic chair and remained fully clothed for 28 minutes The process will be supervised by a female physical therapist who will also provide a lifestyle advice leaflet and education to the participants The training will be provided at a frequency of two sessions per week over 8 weeks The Biofeedback group will receive PFMT with biofeedback andor electrostimulation twice a week for 8 weeks with a physical therapist Participants allocated to the Usual care group will receive the lifestyle advice leaflet only The baseline and immediately post-intervention assessments will include clinical examination of pelvic floor muscle function digital palpation and transperineal ultrasound and three questionnaires about symptom severity of POP occurrence and distress related to pelvic floor dysfunction and impact of pelvic floor dysfunction This study will provide evidence of effectiveness of different modes of physical therapy program for women with POP and health-care professionals working with this population in clinical practice
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