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

NCT04539782 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2020-09-07

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • University of Iceland

    collaborator OTHER

  • Landspitali University Hospital

    lead OTHER

Principal Investigators

  • Þorgerður Sigurðardóttir, MSc · Landspítali University Hospital/University of Iceland, Reykjavík, Iceland.

  • Helga Medek, MD, MSc · Landspítali University Hospital/University of Iceland, Reykjavík, Iceland.

  • Þórarinn Sveinsson, PhD · University of Iceland

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Max Age
80 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-06-10
Primary Completion
2021-06-15
Completion
2021-06-15

Countries

  • Iceland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04539782 on ClinicalTrials.gov