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

NCT04539782 | Unknown

• 1 other identifier: LSH-20-001
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Pelvic Organ Prolapse

Keywords

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

Outcome Measures

Primary Outcomes (1)

• POP-Q

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

  One year

Secondary Outcomes (1)

• The Australian Female Pelvic Floor Questionnaire

  One year

Study Arms (2)

Physiotherapy intervention

EXPERIMENTAL

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

Other: Physiotherapy intervention

No intervention

NO INTERVENTION

Standard care

Interventions

Physiotherapy intervention OTHER

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.

Physiotherapy intervention

Eligibility Criteria

• Age: Up to 80 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Landspitali University Hospital: lead
• University of Iceland: collaborator

Study Sites (1)

Landspitali University Hospital

Reykjavik, 101, Iceland

Location

MeSH Terms

Conditions

Pelvic Organ Prolapse; Recurrence

Condition Hierarchy (Ancestors)

Prolapse; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Disease Attributes; Pathologic Processes

Study Officials

• Þorgerður Sigurðardóttir, MSc

  Landspítali University Hospital/University of Iceland, Reykjavík, Iceland.

  PRINCIPAL INVESTIGATOR

• Helga Medek, MD, MSc

  Landspítali University Hospital/University of Iceland, Reykjavík, Iceland.

  STUDY CHAIR

• Þórarinn Sveinsson, PhD

  University of Iceland

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 31, 2020
• First Posted: September 7, 2020
• Study Start: June 10, 2020
• Primary Completion: June 15, 2021
• Study Completion: June 15, 2021
• Last Updated: September 7, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share

Locations

IC (1)