Clinical trial NCT04539782: A Feasibility Study on the Value of Pelvic Floor Training After Pelvic Organ Prolapse Surgery
Official title: A Feasibility Study on the Value of Pelvic Floor Training After Pelvic Organ Prolapse Surgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pelvic Organ Prolapse
Keywords: pelvic floor
physiotherapy
pelvic organ prolapse
post op
recurrence
Lead sponsor: Landspitali University Hospital
Sponsor class: OTHER
Collaborators: name: University of Iceland
First posted: 2020-09-07
Enrollment: 50
Sex: FEMALE
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The main objective is to assess the feasibility of a randomized controlled trial that investigates the effects of pelvic floor training on recurrence in pelvic organ prolapse surgeries. This will be achieved by measuring POP-Q stage and by a validated questionnaire before surgery and one year after. Women having POP surgery at Landspitali will be offered to participate if they meet the criteria of the research. Participants will be randomized into two groups, interventions and control group that gets standard care at the hospital. The intervention group will meet a physiotherapist 6 weeks post-op for targeted physiotherapy with pelvic floor training, conventional advice and support. Over 16 weeks period participants in intervention group will get physiotherapy four times and get two follow up phone calls. Pelvic floor activity will be measured with EMG and symptoms collected with questionnaire before surgery and year post-op.

Recurrent surgeries are common problem shortly after the first one. POP symtoms can be bothersome for women and reduce their quality of life. More knowledge is needed to figure out if targeted physiotherapy with pelvic floor training can help reduce recurrency and bothersome symptoms.

Detailed description: A feasibility study to assess the practicality of physiotherapy treatment after pelvic organ prolapse (POP) surgery and the effect on recurrent POP symptoms, pelvic floor activity and general physical fitness.

Pelvic organ prolapse is a common problem among women and many do need surgery. Little is known about recurrence of POP surgeries. Pelvic floor muscle training (PFMT) has positive effects on POP symptoms and quality of life. Research shows PFMT can reduce stage of the prolapse.

Before surgery POP-Q stage will be measured by urogynocologist. Pelvic floor muscle activity will be measured with EMG vaginal probes. General physical fitness will be tested with 30s chair-stand and core strenght with prone bride test. An Icelandic version of The Australian Female PelvicFloor questionnaire will be used to assess symptoms and affect on quality of life.

Participants will be randomized into two groups, intervention and control group. The control group gets standard care at the hospital. The interventional group gets physiotherapy with PFMT, conventional advise and support. During 16 weeks intervention participants get four sessions with specialized physiotherapist and two follow up phone calls. Follow up measures will be made at 12 months.

Eligibility criteria: Inclusion Criteria:

* Women having their first POP surgery at LSH
* \<80 years old
* Icelandic speaking

Exclusion Criteria:

* Women that previously have had incontinence surgery, hysterectomy or previous POP surgery.
* Dementia, physical disabilities that could affect the research, previous radiotherapy and neurological diseases.
* Women participating in the research that need to have recurrent POP surgery or incontinence surgery within the year of the surgery.

Primary outcomes:
measure: POP-Q
timeFrame: One year
Secondary outcomes:
measure: The Australian Female Pelvic Floor Questionnaire
timeFrame: One year
Other outcomes:
Locations:
city: Reykjavík
country: Iceland
facility: Landspitali University Hospital
Study officials:
affiliation: Landspítali University Hospital/University of Iceland, Reykjavík, Iceland.
name: Þorgerður Sigurðardóttir, MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: Landspítali University Hospital/University of Iceland, Reykjavík, Iceland.
name: Helga Medek, MD, MSc
role: STUDY_CHAIR
affiliation: University of Iceland
name: Þórarinn Sveinsson, PhD
role: STUDY_CHAIR
References: