investigation of value-added effect of hypopressive exercises on pelvic floor muscle training on the presence and severity of urinary incontinence in postpartum women.
Design
A randomized controlled trial with parallel groups , single blinded.
Settings and conduct
Women diagnosed with stress urinary incontinence will first undergo baseline assessments . those meeting the inclusion criteria and not presenting with any exclusion criteria will be enrolled as participants . instructions on how to perform the exercises will be provided at the physiotherapy clinic , after which participants will continue the sessions at home once they have mastered the techniques.Completion of questionnaires will be based on self-report.
Participants/Inclusion and exclusion criteria
inclusion criteria:
-Age range of 25 to 45 y/o
-History of stress urinary incontinence for a minimum duration of 2 months
-Not having undergone pelvic floor physiotherapy
-Having had healthy childbirth(s)
-
exclusion criteria:
- Pregnancy
-Presence of mental disorders that interfere with comprehension or participation in the interventions
- Having undergone abdominal or pelvic surgery, except for cesarean section
-Inability to perform the intervention exercises
-Presence of any physical disorder that restricts the ability to perform exercises (e.g., cardiovascular disease, active cancer, hypertension, fibromyalgia, COPD, etc.)
Intervention groups
Control group: participants in this group will perform pelvic floor muscle training , 3 times per week for a duration of 4 weeks , each session lasting 30 minutes.
Intervention group: participants in this group will engage in pelvic floor muscle training combined with hypopressive exercises , 3 times per week for a duration of 4 weeks , with each session lasting 30 minutes.
Main outcome variables
severity of urinary incontinence.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20250826067010N1
Registration date:2025-09-18, 1404/06/27
Registration timing:prospective
Last update:2025-09-18, 1404/06/27
Update count:0
Registration date
2025-09-18, 1404/06/27
Registrant information
Name
Mahdis Zare
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 4223 8863
Email address
mahdis.zare.z@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2025-09-23, 1404/07/01
Expected recruitment end date
2026-02-04, 1404/11/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of pelvic floor muscle training alone and combined with hypopressive exercises on urinary Incontinence in postpartum women.
Public title
Comparison of the effect of pelvic floor muscle training alone and combined with hypopressive exercises on urinary Incontinence in postpartum women.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age range of 25 to 45 y/o
History of stress urinary incontinence for a minimum duration of 2 months
Not having undergone pelvic floor physiotherapy
Having at least one delivery
Having had healthy childbirth(s)
Exclusion criteria:
Pregnancy
Presence of mental disorders that interfere with comprehension or participation in the interventions
Having undergone abdominal or pelvic surgery, except for Cesarean section
Inability to perform the intervention exercises
Presence of any physical disorder that restricts the ability to perform exercises (e.g., cardiovascular disease, active cancer, hypertension, fibromyalgia, COPD, etc.)
Age
From 25 years old to 45 years old
Gender
Female
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
52
Randomization (investigator's opinion)
Randomized
Randomization description
To allocate participants into study groups, a block randomization method is used. Participants are randomly assigned in blocks (13 blocks of 4) to two intervention groups (26 people) and control group (26 people). To implement concealment of random allocation, opaque sealed envelopes with a random sequence will be used so that the allocated group is not known before individual allocation. In this method, after generating the random sequence using block randomization, a number of opaque envelopes (to ensure the content of the envelopes is not visible) are prepared based on the specified sample size, and each of the created random sequences is recorded on a card. The cards are then placed in the envelopes in order. To maintain the random sequence, the envelopes are numbered on the outer surface in the same order. Finally, the envelope flaps are sealed, and they are placed sequentially inside a box. At the time the registration of participants begins, one of the envelopes will be opened in order based on the sequence of eligible participants entering the study, revealing the assigned group for that participant.
Blinding (investigator's opinion)
Single blinded
Blinding description
In this study, participants are not aware of which treatment group they are placed in. For this purpose, the participants in both groups are given the same general explanations and the familiarization sessions on how to perform the exercises are held separately for the participants in each group in a way that the participants in each group are not informed that parts of the exercises of the participants in the other group may be different. In terms of the timing of the sessions, each treatment session is considered similar for the participants in both groups
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of school of Rehabilitation Sciences, Shiraz Univeristy of Medical Sciences
Street address
Shahid Dowran Campus, Shiraz University of Medical Sciences, Sadra Town's Entry Road
City
shiraz
Province
Fars
Postal code
7198754361
Approval date
2025-07-30, 1404/05/08
Ethics committee reference number
IR.SUMS.REHAB.REC.1404.013
Health conditions studied
1
Description of health condition studied
Urinary Incontinence
ICD-10 code
N39.498
ICD-10 code description
Other specified urinary incontinence
Primary outcomes
1
Description
severity of urinary incontinence
Timepoint
pre-intervention,post-intervention(1 month after initiation) and at 1-month follow-up
Method of measurement
International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI-SF)
International Consultation on Incontinence(ICIQ)- Lower Urinary Tract Symptoms Quality of Life Questionnaire(LUTSQol)
Intervention groups
1
Description
Intervention group: hypopressive exercises + pelvic floor muscle training ,for 4 weeks ,3 times per week,for 30 minutes each session.
Category
Rehabilitation
2
Description
Control group: pelvic floor muscle training , for four weeks ,three times per week , for 30 minutes each session.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Hospital Affiliated to SUMS
Full name of responsible person
Dr Amin Niakan
Street address
Deputy Chancellor for Treatment, 5th floor, Central Building of SUMS, Zand Boulevard
City
Shiraz
Province
Fars
Postal code
7134814336
Phone
+98 71 3230 5410
Fax
+98 71 3233 1631
Email
info@sums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr Hamid Mohammadi
Street address
7th Floor, SUMS Central Building, Zand Boulevard
City
Shiraz
Province
Fars
Postal code
7134814336
Phone
+98 71 3230 5410
Fax
Email
info@sums.ac.ir
Web page address
https://sums.ac.ir
Grant name
MSc Thesis Grant
Grant code / Reference number
32865
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Mahdis Zare
Position
M.Sc. student
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
Sadra city road , after Amir al-Momenin Burn Hospital , Shahid Dowran Campus,School of Rehabilitation science .
City
Shiraz
Province
Fars
Postal code
7198754361
Phone
+98 71 3212 2600
Email
mahdis.zare.z@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr Mohsen Razeghi
Position
Academic Staff
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Sadra city road , after Amir al-Momenin Burn Hospital , School of Rehabilitation science .
City
Shiraz
Province
Fars
Postal code
7198754361
Phone
+98 71 3212 2600
Email
razeghm@sums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Mahdis Zare
Position
M.Sc. student
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
Sadra city road , after Amir al-Momenin Burn Hospital , School of Rehabilitation science .
City
Shiraz
Province
Fars
Postal code
7198754361
Phone
+98 71 3212 2600
Email
mahdis.zare.z@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
Study Protocol, Statistical Analysis Plan, Clinical Study Report
When the data will become available and for how long
starting immediately after publication
To whom data/document is available
people working in academic institutions
Under which criteria data/document could be used
For Academic Purposes by considering publication general rights
From where data/document is obtainable
Through sending email to Mahdis Zarei
mahdis.zare.z@gmail.com
What processes are involved for a request to access data/document
After receiving the request via email and ensuring compliance with copyright ethics, the requested information will be sent within a maximum period of 2 months.