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

Pelvic Organ Prolapse Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04539782
• Other study ID #: LSH-20-001
• Status: Enrolling by invitation
• Phase: N/A
• Start date: June 10, 2020
• Est. completion date: June 15, 2021

Study information

• Verified date: August 2020
• Source: Landspitali University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 50
• Est. completion date: June 15, 2021
• Est. primary completion date: June 15, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Pelvic Organ Prolapse
• Prolapse

Intervention

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.

Locations

Country	Name	City	State
Iceland	Landspitali University Hospital	Reykjavík

Sponsors (2)

Lead Sponsor	Collaborator
Landspitali University Hospital	University of Iceland

Country where clinical trial is conducted

Iceland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	POP-Q	POP-Q stages are measured by urogynocologists who are blinded outcome assessors.	One year
Secondary	The Australian Female Pelvic Floor Questionnaire	Pelvic floor symptoms	One year