Protocol summary

Study aim
Investigating the effects of adding radiofrequency to conventional pelvic physiotherapy in postpartum urinary incontinence, compared to conventional pelvic physiotherapy alone, on clinical symptoms and MRI findings
Design
Single-blind, randomized, parallel-group clinical trial with 75 participants allocated in a 1:1:1 ratio using permuted block randomization.
Settings and conduct
The study will be conducted at Al-Zahra and Vali-e-Asr Hospitals, Tabriz, Iran. Eligible participants will be randomly assigned to one of three groups. Outcome assessors and the statistical analyst will be blinded to group allocation, and participants and treating therapists will be instructed not to disclose treatment allocation.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Primiparous women aged 18–45 years with postpartum urinary incontinence. Exclusion criteria: Pelvic floor disorders before pregnancy, subsequent pregnancy, cesarean delivery without an active second stage of labor, and previous pelvic surgery.
Intervention groups
Participants will be randomly assigned to one of three groups: Group1: radiofrequency plus conventional pelvic floor physiotherapy (pelvic floor muscle training, electrical stimulation, and biofeedback when indicated); Group2: radiofrequency therapy alone; Group3: routine postpartum care.
Main outcome variables
PRAFAB questionnaire score; pelvic floor muscle strength; pelvic floor muscle endurance; pelvic floor muscle resting tone; quality of life.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20140811018760N13
Registration date: 2026-07-08, 1405/04/17
Registration timing: registered_while_recruiting

Last update: 2026-07-08, 1405/04/17
Update count: 0
Registration date
2026-07-08, 1405/04/17
Registrant information
Name
Fariba Ghaderi
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1333 4647
Email address
ghaderif@tbzmed.ac.ir
Recruitment status
recruiting
Funding source
Expected recruitment start date
2026-06-22, 1405/04/01
Expected recruitment end date
2027-06-22, 1406/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effects of adding radiofrequency to conventional pelvic physiotherapy in postpartum urinary incontinence, compared to conventional pelvic physiotherapy alone, on clinical symptoms and MRI findings, a Randomized Clinical Trail
Public title
Effect of TECAR therapy on postpartum urinary incontinence
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Primiparous women aged 18–45 years who are between 6 weeks and 12 months postpartum following a vaginal delivery. A PRAFAB questionnaire score of ≥8. Presence of at least one of the following structural or functional abnormalities on the baseline clinical assessment or magnetic resonance imaging (MRI): * Levator hiatus area >25 cm² during the Valsalva maneuver; * Levator ani muscle avulsion; * Reduced relative thickness of the puborectalis muscle compared with the contralateral side Ability to perform a voluntary pelvic floor muscle contraction. Willingness and ability to participate in a 6–8-week treatment program and undergo two MRI assessments. Provision of written informed consent.
Exclusion criteria:
Subsequent pregnancy during the study period. Cesarean delivery without an active second stage of labor (because of the different pathophysiology of levator ani muscle injury). Severe pelvic organ prolapse (POP-Q stage ≥2) or the need for specialized conservative or surgical treatment. Active vaginal infection, untreated bacterial vaginosis, or pelvic inflammatory disease. History of pelvic floor disorders before pregnancy, including urinary incontinence, fecal incontinence, pelvic organ prolapse, or chronic pelvic pain. Neuromuscular disorders affecting pelvic floor muscle contraction (e.g., multiple sclerosis, spinal cord injury, or severe peripheral neuropathy). Presence of active electronic or metallic implants (e.g., an intrauterine device [IUD], cardiac pacemaker, or neurostimulator) that may interfere with radiofrequency treatment Pelvic or perineal surgery within the previous 6 months. Receipt of specialized pelvic floor treatment (e.g., supervised pelvic floor muscle training, radiofrequency therapy, or laser therapy) within the previous 3 months. Intolerance to the vaginal radiofrequency probe. Claustrophobia preventing MRI assessment. Presence of active myofascial trigger points in the pelvic floor muscles on physical examination.
Age
From 18 years old to 45 years old
Gender
Female
Phase
N/A
Groups that have been masked
  • Care provider
  • Investigator
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 75
Randomization (investigator's opinion)
Randomized
Randomization description
The random allocation sequence will be generated by an independent statistician using a computer-generated randomization sequence based on permuted blocks of varying sizes (2, 4, and 6), with a 1:1:1 allocation ratio across the three study groups. Allocation concealment will be ensured by placing the group assignments in sequentially numbered, opaque, sealed envelopes prepared by an independent individual not involved in participant recruitment or assessment. The envelopes will remain sealed until a participant has been enrolled. Following enrollment, the next envelope in the sequence will be opened, and the participant will be assigned to the indicated study group.
Blinding (investigator's opinion)
Single blinded
Blinding description
This study will employ a single-blind design in which the outcome assessors and the statistical analyst will remain blinded to participants’ group allocation. Because of the nature of the interventions, blinding of participants and treating therapists is not feasible. To preserve assessor blinding, participants and treating therapists will be instructed not to disclose or discuss treatment allocation with the outcome assessors at any time during the study.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Tabriz University of Medical Sciences
Street address
Rehabilitation Faculty, Tabriz University of Medical Sciences, Daneshgah Ave
City
Tabriz
Province
East Azarbaijan
Postal code
5166414766
Approval date
2026-06-07, 1405/03/17
Ethics committee reference number
IR.TBZMED.REC.1405.152

Health conditions studied

1

Description of health condition studied
Postpartum urinary incontinence
ICD-10 code
N39.4
ICD-10 code description
Other specified urinary incontinence

Primary outcomes

1

Description
urinary incontinence
Timepoint
The measurement will be performed in three stages: before the start of treatment, immediately after the end of treatment, and tree month after the last treatment session.
Method of measurement
PRAFAB Questionaire

Secondary outcomes

1

Description
Pelvic floor dysfunction during pregnancy and postpartum
Timepoint
The measurement will be performed in three stages: before the start of treatment, immediately after the end of treatment, and tree month after the last treatment session.
Method of measurement
PFQ-postpartum and pregnancy Questionaire

Intervention groups

1

Description
Intervention group1: (Conventional Pelvic Floor Physiotherapy):Participants in this group will receive conventional pelvic floor physiotherapy, including education regarding pelvic floor anatomy and function, pelvic floor muscle training (PFMT), biofeedback for participants who are unable to correctly identify or contract their pelvic floor muscles, and intravaginal electrical stimulation when indicated. The supervised treatment program will be conducted for 6 weeks, with two sessions per week, each lasting 45–60 minutes. To maintain treatment effects, participants will subsequently perform a home-based PFMT program for an additional 6 weeks, with a frequency of 3–4 sessions per week.
Category
Rehabilitation

2

Description
Intervention group 2: (Radiofrequency Therapy):Participants in this group will receive radiofrequency therapy using capacitive–resistive diathermy (TECAR therapy).Phase 1: Intravaginal Capacitive RadiofrequencyAn intravaginal electrode covered with a disposable sheath and appropriate lubricant will be inserted into the vagina and applied for 8–10 minutes using either a static position or very gentle movements. Energy delivery will be uniform and performed without mechanical pressure. Treatment intensity will be adjusted within the subthermal to mild thermal range according to patient feedback, producing a comfortable, pain-free sensation of warmth.Phase 2: External Resistive RadiofrequencyExternal resistive radiofrequency will be applied using a resistive surface electrode over the external perineal region for 10–12 minutes. The electrode will be moved slowly and uniformly in circular motions over the treatment area without excessive mechanical pressure. Treatment intensity will be maintained within the subthermal to mild thermal range and adjusted according to patient tolerance.Participants will receive a total of 12 treatment sessions, delivered twice weekly for 6 consecutive weeks.
Category
Rehabilitation

3

Description
Control group(Routin care): Participants in the control group will receive routine postpartum care as provided in the participating healthcare centers and will not receive any active pelvic floor physiotherapy intervention during the study period. Specifically, they will not receive pelvic floor education, pelvic floor muscle training, electrical stimulation, biofeedback, manual therapy, or radiofrequency treatment.Routine care will consist of standard medical follow-up, general non-structured advice, and other non-physiotherapy interventions that are routinely provided as part of usual postpartum clinical care.
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Alzahra hospital
Full name of responsible person
Fariba Ghaderi
Street address
ALzahra Hospital,South Artesh Ave., Tabriz, Iran
City
Tabriz
Province
East Azarbaijan
Postal code
5167631444
Phone
+98 41 3334 5121
Fax
+98 41 3334 5121
Email
ghaderif@tbzmed.ac.ir
Web page address

2

Recruitment center
Name of recruitment center
Vali-asr Hospital
Full name of responsible person
Fariba Ghaderi
Street address
Vali-asr Hospital, The beginning of Zafaranieh,Tabriz, Iran
City
Tabriz
Province
East Azarbaijan
Postal code
14469337140
Phone
+98 41 3332 1736
Email
ghaderif@tbzmed.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Khosro Adibkia
Street address
Faculty of Rehabilitation Sciences, University of Medical Sciences, 29 Bahman Blvd, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5166414766
Phone
+98 41 3337 2072
Email
rehab.fac@tbzedmed.ac.ir
Web page address
https://rehabilitation.tbzmed.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Fariba Ghaderi
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Rehabilitation faculty., Tabriz university of medical sciences., Golgasht street., Azadi street
City
Tabriz
Province
East Azarbaijan
Postal code
5166414766
Phone
+98 41 3335 2072
Email
ghaderif@tbzmed.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Fariba Ghaderi
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Rehabilitation faculty., Tabriz university of medical sciences., Golgasht street., Azadi street
City
Tabriz
Province
East Azarbaijan
Postal code
5166414766
Phone
+98 41 3335 2072
Email
ghaderif@tbzmed.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr Fariba Ghaderi
Position
Professor- PhD of physiotherapy
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Rehabilitation faculty, Tabriz University of Medical Sciences.
City
Tabriz
Province
East Azarbaijan
Postal code
5166414766
Phone
+98 413339771
Fax
Email
ghaderif@tbzmed.ac.ir
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
"There is no further information"
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
1. The data file of the participants will be designed and collected without mentioning the name and with ID definition. 2. The study protocol will be published in the form of an article after the start of data collection. 3. The statistical analysis map will be prepared in SPSS file format after data collection. 4. The informed consent form of this study was designed and will be available to the participants. 5. The clinical study report will be prepared and published in the form of six-month reports and the final report.
When the data will become available and for how long
Access to data begins six months after publication of study results
To whom data/document is available
The study protocol and final study results will be available to the public after publication. Access to other data is done upon request. Under which criteria data/document could be used
Under which criteria data/document could be used
In order to design other research projects in this field, data will be sent. From where data/document is obtainable
From where data/document is obtainable
To receive the data and documents of this study, the scientific officer of this project can be contacted via e-mail. email address: What processes are involved for a request to access data/document
What processes are involved for a request to access data/document
After sending and reviewing the request for access to the data, in accordance with the principle of confidentiality of the personal information of the study participants, the data will be sent within a few days to a few weeks.
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