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IRCT20140811018760N13 IRCT 2026-07-08 Tabriz University of Medical Sciences Effect of TECAR therapy on postpartum urinary incontinence 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 2026-06-22 anticipated 75 Recruiting https://irct.ir/trial/90697 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, 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 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. N/A Postpartum urinary incontinence. Intervention 1: 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. Intervention 2: 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. Intervention 3: 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. No - There is not a plan to make this available Justification or reason for not sharing IPD is "There is no further information"
public Fariba Ghaderi
Rehabilitation faculty., Tabriz university of medical sciences., Golgasht street., Azadi street
Tabriz Iran (Islamic Republic of) 5166414766 +98 41 3335 2072 ghaderif@tbzmed.ac.ir Tabriz University of Medical Sciences scientific Fariba Ghaderi
Rehabilitation faculty., Tabriz university of medical sciences., Golgasht street., Azadi street
Tabriz Iran (Islamic Republic of) 5166414766 +98 41 3335 2072 ghaderif@tbzmed.ac.ir Tabriz University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) 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. 18 years 45 years Female 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. N39.4 Other specified urinary incontinence Rehabilitation Rehabilitation Other 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. 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. 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. 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. 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. Tabriz University of Medical Sciences Approved 2026-06-07 Ethics committee of Tabriz University of Medical Sciences Rehabilitation Faculty, Tabriz University of Medical Sciences, Daneshgah Ave Tabriz East Azarbaijan Iran (Islamic Republic of)