Skip to content

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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04539782
Enrollment
50
Registered
2020-09-07
Start date
2020-06-10
Completion date
2021-06-15
Last updated
2020-09-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pelvic Organ Prolapse

Keywords

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

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.

Interventions

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

University of Iceland
CollaboratorOTHER
Landspitali University Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
FEMALE
Age
No minimum to 80 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
POP-QOne yearPOP-Q stages are measured by urogynocologists who are blinded outcome assessors.

Secondary

MeasureTime frameDescription
The Australian Female Pelvic Floor QuestionnaireOne yearPelvic floor symptoms

Countries

Iceland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026