Effects of pelvic floor muscles training on sexual dysfunction - randomised controlled trial

• Register: ANZCTR
• Last refreshed on: 13 January 2020
• Main ID: ACTRN12615000248561
• Date of registration: 18/03/2015
• Prospective Registration: Yes
• Primary sponsor: Manuela Filipec
• Public title: Effects of pelvic floor muscles training on sexual dysfunction - randomised controlled trial
• Scientific title: Effects of pelvic floor muscles training on pelvic floor muscle strength and endurance in patients with sexual dysfunction
• Date of first enrolment: 15/11/2018
• Target sample size: 302
• Recruitment status: Active, not recruiting
• URL: https://anzctr.org.au/ACTRN12615000248561.aspx
• Study type: Interventional
• Study design: Purpose: Treatment; Allocation: Randomised controlled trial; Masking: Blinded (masking used);Assignment: Parallel;Type of endpoint: Efficacy;
• Phase: Not Applicable

Countries of recruitment

Croatia

Contacts

• Name: Ms Manuela Filipec

• Name: Ms Manuela Filipec

Key inclusion & exclusion criteria

Inclusion criteria: vaginismus or dyspareunia or vulvodynia or erectile dysfunction or premature ejaculation or hysterectomia
Exclusion criteria: hyperthyroidism, antipsychotics, antidepressants, sedatives, narcotics, chemotherapy

Age minimum: 30 Years
Age maximum: 50 Years
Gender: Both males and females

Health Condition(s) or Problem(s) studied

Reproductive Health and Childbirth - Other reproductive health and childbirth disorders

Physical Medicine / Rehabilitation - Physiotherapy

Sexual dysfunction;Pain and quality of sexual life;
Sexual dysfunction
Pain and quality of sexual life

Intervention(s)

Assessment of pelvic floor muscles function through PERFECT scheme (power, endurance, repetition, fast contraction, co-contraction and timing of pelvic floor muscles). Participants will undergo assessment immediately prior to intervention and at four week post intervention.
Pelvic floor muscle training – these are exercises for strength and endurance of pelvic floor muscles. The number of pelvic floor exercises undertaken as part of each session is 8-10 times with duration of each session for 30 minutes. The sessions are carried out on an individual basis. There will be 4 appointments with a physiotherapist over 4 weeks, supplemented by a daily program of 3 exercise sessions. The duration of each session with physiotherapist is 45 minutes. The duration of daily home program sessions is 8-10 repetitions 3x30 minute sessions daily for 4 weeks. Each session involve voluntary contraction of urethral, vaginal and anal opening in supine position, side-lying position, sitting and in standing position. Duration of each voluntary contraction of each opening is 6-8 seconds under supervision by physiotherapists.There are not applicable strategies for monitor adherence to the intervention.TENS is not administered to the intervention group. The duration period between treatments is one week.

Primary Outcome(s)

Pelvic floor muscle endurance
For assessment of pelvic floor muscle endurance is used PERFECT SCHEME(p-power, e-endurance,r-repetition, f-fast contraction, e-elevation, c-coontraction, t-timing). Endurance - the duration of the contraction is noted, up to 10 seconds.
[Immediately prior to intervention and at four week post intervention]

Pelvic floor muscle strength
For assessment of pelvic floor muscle strength is used PERFECT SCHEME(p-power, e-endurance,r-repetition, f-fast contraction, e-elevation, c-coontraction, t-timing). The power/strength of the maximum voluntary contraction is determined from the modified Oxford scale.
Modified Oxford Grading:
Grade 0: No discernible contraction
Grade 1: Very weak contraction, a”flicker”. Slight change in tension only
Grade 2: Weak contraction
Grade 3: Moderate contraction with some squeeze and lift ability.
Grade 4 : Good contraction; squeeze and lift against resistance
Grade 5: Strong contraction, squeeze and lift against strong resistance.

[Immediately prior to intervention and at four week post intervention]

Secondary Outcome(s)

Pain at sexual disfunction as assessed by number pain rating scale (NPRT)[Immediately prior to intervention and at four week post intervention]

Sexual Quality of Life (Male) Instrument and Female sexual function index, which measure quality of sexual life, activity limitation and emotional perception of sexual dysfunction[Immediately prior to intervention and at four week post intervention]

Secondary ID(s)

Nil

Source(s) of Monetary Support

Clinical hospital “Sveti Duh” Department of physical medicine and rehabilitation

Ethics review

Status: Approved
Approval date:
Contact:

Ethic Committee of Clinical hospital “Sveti Duh”

Results

• Date Posted: 05/06/2019