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

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.

Study Overview

• Status: Unknown
• Conditions: Pelvic Organ Prolapse
• Intervention / Treatment: Other: Physiotherapy intervention

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.

• Study Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Iceland
  • Reykjavík, Iceland, 101
    • Landspitali University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 80 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Physiotherapy intervention; Pelvic floor muscle training given by a physiotherapist in four sessions and follow up phone calls twice in 14 weeks	Other: Physiotherapy intervention; 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.
No Intervention: No intervention; Standard care

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
POP-Q	POP-Q stages are measured by urogynocologists who are blinded outcome assessors.	One year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Australian Female Pelvic Floor Questionnaire	Pelvic floor symptoms	One year

Collaborators and Investigators

• Sponsor: Landspitali University Hospital
• Collaborators: University of Iceland
• Investigators: Principal Investigator: Þorgerður Sigurðardóttir, MSc, Landspítali University Hospital/University of Iceland, Reykjavík, Iceland.; Study Chair: Helga Medek, MD, MSc, Landspítali University Hospital/University of Iceland, Reykjavík, Iceland.; Study Chair: Þórarinn Sveinsson, PhD, University of Iceland

Study record dates

Study Major Dates

• Study Start (Actual): June 10, 2020
• Primary Completion (Anticipated): June 15, 2021
• Study Completion (Anticipated): June 15, 2021

Study Registration Dates

• First Submitted: August 31, 2020
• First Submitted That Met QC Criteria: August 31, 2020
• First Posted (Actual): September 7, 2020

Study Record Updates

• Last Update Posted (Actual): September 7, 2020
• Last Update Submitted That Met QC Criteria: August 31, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Keywords: physiotherapy; recurrence; pelvic organ prolapse; pelvic floor; post op
• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Prolapse; Pelvic Organ Prolapse
• Other Study ID Numbers: LSH-20-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No