Investigating the effects of Pelvic Floor Muscle Training on Pelvic floor muscles’ function and quality of life in diabetic pregnant women with urinary incontinence
Design
Diabetic pregnant women with urinary incontinence form the statistical population. Participants are randomly assigned. Web-based randomization method is used to generate random sequence. The formula will be used to determine the sample size in each group. The number of samples in each group was calculated to be 20 and 40 in total.
Settings and conduct
This study will be conducted in Shahid Sadoughi University of Yazd. 25-week pregnant mothers suffering from urinary incontinence are included in the study by referring to a gynecologist through a simple sampling method. All participants sign an informed consent form. Participants will be randomly divided into treatment (number = 20) and control (number = 20) groups. Participants are assessed before and after 10 weeks of intervention. The evaluator will not know about the grouping allocation of the participants. Only the participants and the physiotherapist involved in training the exercises will know about the assignment of the groups.
Participants/Inclusion and exclusion criteria
Safe pregnancy; presence of urinary incontinence; first pregnancy; age: 20-30 years old; presence of Gestational Diabetes Mellitus
Intervention groups
Diabetic treatment: the protocol includes PFM strengthening exercises that include 3 sets of 10 slow contractions (6 to 8 s) and a rest period equivalent to the contraction time, and finally 3 to 4 fast contractions in the supine, sitting and standing positions for at least 3 times a day. Exercises are done at home for 10 consecutive weeks (25 to 35 weeks of pregnancy). Diabetic control: A pamphlet regarding PFM training will be given.
Main outcome variables
Quality of life; bladder base displacement; strength and endurance of pelvic floor muscles
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20160601028203N3
Registration date:2023-04-05, 1402/01/16
Registration timing:prospective
Last update:2023-04-05, 1402/01/16
Update count:0
Registration date
2023-04-05, 1402/01/16
Registrant information
Name
Parisa Ghadiri Harati
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 7754 2057
Email address
a_karimi@bmsu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-04-21, 1402/02/01
Expected recruitment end date
2023-08-23, 1402/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effects of Pelvic Floor Muscle Training in diabetic pregnant women with urinary incontinence
Public title
Effects of Pelvic Floor Muscle Training
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
First pregnancy
Gestational age of 25 week
Presence of urinary incontinence
Gestational diabetes mellitus
Exclusion criteria:
High risk pregnancy
Presence of other neuromuscular disease
Use of other treatment for urinary inontinence
Twin pregnancy
Age
From 20 years old to 30 years old
Gender
Female
Phase
N/A
Groups that have been masked
Outcome assessor
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
The creation of randomization sequence will be limited block randomization with random block size (block size: 2, 4, 6). In this way, the study participants are randomly placed in one of the two control or treatment groups. Web-based randomization method (www.sealedenvelope.com) is used to generate random sequence. Opaque sealed envelopes with a random sequence will be used to conceal the random allocation. This work is done with the help of a person who has no role in the research process. Based on the order of entry of eligible participants into the study, which are selected by the gynecologist, one of the envelopes will be opened and the group assigned to that participant will be determined.
Blinding (investigator's opinion)
Single blinded
Blinding description
The evaluator will not know about the allocation of grouping of people participating in this study. Only the participants and the physiotherapist involved in training the exercises will know about the assignment of the groups.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committees of Vice-Chancellor in Research Affairs - Shahid Beheshti University of Me
Street address
Physiotherapy department, Rehabilitation school of Shahid Beheshti University of Medical Sciences, Damavand Ave, Tehran
City
Tehran
Province
Tehran
Postal code
1616913111
Approval date
2021-11-28, 1400/09/07
Ethics committee reference number
IR.SBMU.RETECH.REC.1400.611
Health conditions studied
1
Description of health condition studied
Urinary incontinence
ICD-10 code
N39.3
ICD-10 code description
Stress incontinence (female) (male)
Primary outcomes
1
Description
Comparison of bladder base displacement with ultrasound to evaluate the strength of the pelvic floor muscles
Timepoint
Measuring of bladder base displacement at the beginning of the third trimester (28-25 weeks), late third trimester (35-32 weeks)
Method of measurement
Measurement of bladder base displacement by ultrasound
Secondary outcomes
1
Description
Measurement of quality of life
Timepoint
Early third trimester (25-28 weeks), late third trimester (35-32 weeks)
Method of measurement
Measurement of quality of life with incontinence quality of life (I-QOL) questionnaire
Intervention groups
1
Description
Intervention group: The protocol consisted of pelvic floor muscle strengthening exercises. Women were encouraged to perform three sets of ten slow contractions, holding each contraction for 6 to 8 seconds, followed by a rest period equal to the duration of the contraction. and finally three to four rapid contractions are performed in supine, sitting and standing positions for at least three times a day. Mothers do these exercises for 10 consecutive weeks (25 weeks of pregnancy to 35 weeks of pregnancy) and gradually the number of contractions increases. In each exercise, pay attention that the muscles of the pelvic floor are contracted and the muscles of other parts of the pelvis are relaxed. During the research, the examiner communicates with the mother two days a week through social networks and phone calls.
Category
Rehabilitation
2
Description
Control group: This group will be given the usual recommendations for care during this period and pelvic floor strengthening exercises in the form of pamphlets.