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

• ClinicalTrials.gov Identifier: NCT04539782
• Recruitment Status: Enrolling by invitation
• First Posted: September 7, 2020
• Last Update Posted: September 7, 2020
• Sponsor: Landspitali University Hospital
• Collaborator: University of Iceland
• Information provided by (Responsible Party): Landspitali University Hospital

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.

Condition or disease	Intervention/treatment	Phase
Pelvic Organ Prolapse	Other: Physiotherapy intervention	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 50 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Prevention
• Official Title: A Feasibility Study on the Value of Pelvic Floor Training After Pelvic Organ Prolapse Surgery
• Actual Study Start Date: June 10, 2020
• Estimated Primary Completion Date: June 15, 2021
• Estimated Study Completion Date: June 15, 2021

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

1. POP-Q [ Time Frame: One year ]
   POP-Q stages are measured by urogynocologists who are blinded outcome assessors.

Secondary Outcome Measures :

1. The Australian Female Pelvic Floor Questionnaire [ Time Frame: One year ]
   Pelvic floor symptoms

Eligibility Criteria

• Ages Eligible for Study: up to 80 Years (Child, Adult, Older Adult)
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

Iceland

Landspitali University Hospital

Reykjavík, Iceland, 101

Sponsors and Collaborators

Landspitali University Hospital

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

More Information

• Responsible Party: Landspitali University Hospital
• ClinicalTrials.gov Identifier: NCT04539782
• Other Study ID Numbers: LSH-20-001
• First Posted: September 7, 2020
• Last Update Posted: September 7, 2020
• Last Verified: August 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Landspitali University Hospital:

pelvic floor; physiotherapy; pelvic organ prolapse; post op; recurrence

Additional relevant MeSH terms:

Prolapse; Pelvic Organ Prolapse; Pathological Conditions, Anatomical