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

Primary Purpose

Pelvic Organ Prolapse

Status
Unknown status
Phase
Not Applicable
Locations
Iceland
Study Type
Interventional
Intervention
Physiotherapy intervention
Sponsored by
Landspitali University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Pelvic Organ Prolapse focused on measuring pelvic floor, physiotherapy, pelvic organ prolapse, post op, recurrence

Eligibility Criteria

undefined - 80 Years (Child, Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Landspitali University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Physiotherapy intervention

No intervention

Arm Description

Pelvic floor muscle training given by a physiotherapist in four sessions and follow up phone calls twice in 14 weeks

Standard care

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

The Australian Female Pelvic Floor Questionnaire
Pelvic floor symptoms

Full Information

First Posted
August 31, 2020
Last Updated
August 31, 2020
Sponsor
Landspitali University Hospital
Collaborators
University of Iceland
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1. Study Identification

Unique Protocol Identification Number
NCT04539782
Brief Title
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

2. Study Status

Record Verification Date
August 2020
Overall Recruitment Status
Unknown status
Study Start Date
June 10, 2020 (Actual)
Primary Completion Date
June 15, 2021 (Anticipated)
Study Completion Date
June 15, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Landspitali University Hospital
Collaborators
University of Iceland

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pelvic Organ Prolapse
Keywords
pelvic floor, physiotherapy, pelvic organ prolapse, post op, recurrence

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Physiotherapy intervention
Arm Type
Experimental
Arm Description
Pelvic floor muscle training given by a physiotherapist in four sessions and follow up phone calls twice in 14 weeks
Arm Title
No intervention
Arm Type
No Intervention
Arm Description
Standard care
Intervention Type
Other
Intervention Name(s)
Physiotherapy intervention
Intervention Description
Compare the effect of structured pelvic floor muscle training supported by physiotherapist post operation on POP on recurrence of symptoms or symptoms in a new compartment, quality of life and pelvic floor muscle function.
Primary Outcome Measure Information:
Title
POP-Q
Description
POP-Q stages are measured by urogynocologists who are blinded outcome assessors.
Time Frame
One year
Secondary Outcome Measure Information:
Title
The Australian Female Pelvic Floor Questionnaire
Description
Pelvic floor symptoms
Time Frame
One year

10. Eligibility

Sex
Female
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Þorgerður Sigurðardóttir, MSc
Organizational Affiliation
Landspítali University Hospital/University of Iceland, Reykjavík, Iceland.
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Helga Medek, MD, MSc
Organizational Affiliation
Landspítali University Hospital/University of Iceland, Reykjavík, Iceland.
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Þórarinn Sveinsson, PhD
Organizational Affiliation
University of Iceland
Official's Role
Study Chair
Facility Information:
Facility Name
Landspitali University Hospital
City
Reykjavík
ZIP/Postal Code
101
Country
Iceland

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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