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Trial registered on ANZCTR


Registration number
ACTRN12615000248561
Ethics application status
Approved
Date submitted
10/12/2014
Date registered
18/03/2015
Date last updated
5/06/2019
Date data sharing statement initially provided
5/06/2019
Type of registration
Prospectively registered

Titles & IDs
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
Secondary ID [1] 285826 0
Nil
Universal Trial Number (UTN)
Nil
Trial acronym
Nil
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Sexual dysfunction 293741 0
Pain and quality of sexual life 293742 0
Condition category
Condition code
Physical Medicine / Rehabilitation 294042 294042 0 0
Physiotherapy
Reproductive Health and Childbirth 294284 294284 0 0
Other reproductive health and childbirth disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 290805 0
Rehabilitation
Comparator / control treatment
Transcutaneous electrical nerve stimulation (TENS) will be put on the participant once weekly for 4 weeks but will not emit any current through the electrodes which will be placed over the buttock region for 10 minutes. It is false treatment as it has no treatment value as there will be no output.
Control group
Placebo

Outcomes
Primary outcome [1] 293819 0
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.
Timepoint [1] 293819 0
Immediately prior to intervention and at four week post intervention
Primary outcome [2] 293820 0
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.
Timepoint [2] 293820 0
Immediately prior to intervention and at four week post intervention
Secondary outcome [1] 311929 0
Pain at sexual disfunction as assessed by number pain rating scale (NPRT)
Timepoint [1] 311929 0
Immediately prior to intervention and at four week post intervention
Secondary outcome [2] 311930 0
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
Timepoint [2] 311930 0
Immediately prior to intervention and at four week post intervention

Eligibility
Key inclusion criteria
vaginismus or dyspareunia or vulvodynia or erectile dysfunction or premature ejaculation or hysterectomia
Minimum age
30 Years
Maximum age
50 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
hyperthyroidism, antipsychotics, antidepressants, sedatives, narcotics, chemotherapy

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Suitable patients idnetified by gynaecologists will be referred to the study. Information will be provide to participants and baseline questionnaire and consent form posted to potential participants. On return of form participants will be assessed by physiotherapists with regard to pelvic floor muscle function measures, then randomised to intervention or control group by the Project Coordinator via the remote automated computer randomisation application.Every consenting participant will be registered and given a unique trial number.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Automated computer randomisation sequence
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Descriptive statistics is used for describing the distribution of a single variable, including its central tendency (including the mean, median, and mode) and dispersion (including the range and quantiles of the data-set, and measures of spread such as the variance and standard deviation).
The significance of differences in power and endurance of pelvic floor muscle at the first and the last assessment are determined by the chi square test.
Correlation between differences in power and endurance of pelvic floor muscle at the first and the last assessment is determined by the correlation coefficient.
Correlation between power of pelvic floor muscle and quality of sexual life is determined by the correlation coefficient.
Correlation between endurance of pelvic floor muscle and quality of sexual life is determined by the correlation coefficient.
Correlation between pain and quality of sexual life is determined by the correlation coefficient.
Confidence interval will be used to assess possible differences interval value based on perceived differences between samples.
All results will be considered significant at p < 0.05.
The sample was selected randomly. The method of random sampling was conducted using a random number table. List with the initials of participants will be added to the numbers, and then will be randomly assigned numbers from a table of random numbers. The study will involve participants whose initials placed under a number that is randomly selected from a table of random numbers.
The number of participants needed to achieve study objectives was determined by the computer calculator program to estimate the required sample size at the Medical Faculty, University of Zagreb (web.mef.hr/if/alati/racunala/tekst/velicina_u.htm).
The number of participants needed to achive study objectives will be determined by the significance level, the statistical power, smaller minimum detectable differences. An increase in sample size will be caused by either decreasing the significance level, by raising the statistical power and by demanding smaller minimum detectable differences. A minimum necessary group size based on this consideration ensures that a mean group difference can be detected at the significance level less than 0.05 with a minimum statistical power of 0.80. Effect size will be selected as the smallest effect that would be important to detect (a change that would be considered meaningful and worthwhile by the patients), in the sense that any effect would not be of clinical of substantive significance. Effect size will be measured as change obtained by dividing the difference in scores from baseline to postreatment by the SD of the baseline scores. The value of the effect size represents the number of SDs by which the scores have changed from baseline to postreatment. An effect size of 0.2 will be considered small, 0.5 moderate, and 0.8. large.

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
28/03/2019
Actual
15/11/2018
Date of last participant enrolment
Anticipated
28/03/2019
Actual
28/03/2019
Date of last data collection
Anticipated
3/02/2020
Actual
Sample size
Target
302
Accrual to date
Final
302
Recruitment outside Australia
Country [1] 6544 0
Croatia
State/province [1] 6544 0
Zagreb

Funding & Sponsors
Funding source category [1] 290386 0
Hospital
Name [1] 290386 0
Clinical hospital “Sveti Duh”
Department of physical medicine and rehabilitation

Country [1] 290386 0
Croatia
Primary sponsor type
Individual
Name
Manuela Filipec
Address
Clinical hospital “Sveti Duh”
Department of physical medicine and rehabilitation
Sveti Duh 64
10 000 Zagreb
Croatia
Country
Croatia
Secondary sponsor category [1] 289113 0
None
Name [1] 289113 0
Address [1] 289113 0
Country [1] 289113 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292090 0
Ethic Committee of Clinical hospital “Sveti Duh”
Ethics committee address [1] 292090 0
Ethics committee country [1] 292090 0
Croatia
Date submitted for ethics approval [1] 292090 0
Approval date [1] 292090 0
17/11/2014
Ethics approval number [1] 292090 0
012-135106

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 53442 0
Ms Manuela Filipec
Address 53442 0
Clinical hospital “Sveti Duh”
Department of physical medicine, rehabilitation and reumatology
Sveti Duh 64
10 000 Zagreb
Country 53442 0
Croatia
Phone 53442 0
+ 385917316607
Fax 53442 0
+385 13712206
Email 53442 0
manuela.filipec@gmail.com
Contact person for public queries
Name 53443 0
Manuela Filipec
Address 53443 0
Clinical hospital “Sveti Duh”
Department of physical medicine, rehabilitation and reumatology
Sveti Duh 64
10 000 Zagreb
Country 53443 0
Croatia
Phone 53443 0
+ 385917316607
Fax 53443 0
+385 13712206
Email 53443 0
manuela.filipec@gmail.com
Contact person for scientific queries
Name 53444 0
Manuela Filipec
Address 53444 0
Clinical hospital “Sveti Duh”
Department of physical medicine, rehabilitation and reumatology
Sveti Duh 64
10 000 Zagreb
Country 53444 0
Croatia
Phone 53444 0
+ 385917316607
Fax 53444 0
+38513712206
Email 53444 0
manuela.filipec@gmail.com

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Data for this trial will not be available because decison of Clinical hospiatl "Sveti Duh".


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.