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Clinical Trials/NCT04539782
NCT04539782
Unknown
Not Applicable

A Feasibility Study on the Value of Pelvic Floor Training After Pelvic Organ Prolapse Surgery

Landspitali University Hospital1 site in 1 country50 target enrollmentJune 10, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Pelvic Organ Prolapse
Sponsor
Landspitali University Hospital
Enrollment
50
Locations
1
Primary Endpoint
POP-Q
Last Updated
5 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
June 10, 2020
End Date
June 15, 2021
Last Updated
5 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Sponsor
Landspitali University Hospital
Responsible Party
Sponsor

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.

Outcomes

Primary Outcomes

POP-Q

Time Frame: One year

POP-Q stages are measured by urogynocologists who are blinded outcome assessors.

Secondary Outcomes

  • The Australian Female Pelvic Floor Questionnaire(One year)

Study Sites (1)

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