Tokyo, May 11 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000061484) titled 'Elucidation of the Mechanisms Underlying the Effects of Surface Electrical Stimulation on Pelvic Floor Muscle Contraction Characteristics in Nulliparous Women' on May 11.

Study Type: Interventional

Study Design: Basic Design - Parallel Randomization - Randomized Blinding - Open -no one is blinded Control - Placebo

Primary Sponsor: Institute - Other

Condition: Condition - Nulliparous Women with Difficulty in Pelvic Floor Muscle Contraction Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - The purpose of this study is to elucidate the mechanisms by which surface electrical stimulation of the pudendal nerve affects pelvic floor muscle contraction in nulliparous women with difficulty in pelvic floor muscle contraction. Basic objectives2 - Others

Intervention: Interventions/Control_1 - Intervention: Electrical stimulation at the maximum tolerable level combined with voluntary pelvic floor muscle contractions (5 seconds of electrical stimulation with contraction followed by 10 seconds of relaxation, repeated 10 times per session, for a total of 3 sessions). Interventions/Control_2 - Control condition: Voluntary pelvic floor muscle contractions (5 seconds of contraction followed by 10 seconds of relaxation, repeated 10 times per session, for a total of 3 sessions).

Eligibility: Age-lower limit - 18 years-old = Gender - Female Key inclusion criteria - Nulliparous women aged 18-30 years Key exclusion criteria - (1) Pregnancy or a history of childbirth (2) History of or current treatment for gynecological diseases (3) Participation in professional sports activities (4) BMI of 30 kg/m2or higher (5) Sensory impairment in the perineal region (6) Skin damage or inflammation in the perineal region (7) Metal or plastic implants in the perineal region (8) History of epilepsy, urinary tract infection, bleeding disorders, neurological abnormalities, or psychiatric treatment (9) History of orthopedic disorders related to the spine, pelvic girdle, or hip joint (10) Vascular disorders such as thrombosis, venous thrombosis, or varicose veins (11) Use of implanted electronic devices such as a pacemaker (12) Acute painful conditions of unknown origin (13) Cardiac disorders or malignant tumors (14) Febrile or infectious diseases (15) During menstruation (16) Ability to voluntarily contract the pelvic floor muscles Target Size - 48

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2026 Year 04 Month 25 Day Anticipated trial start date - 2026 Year 05 Month 12 Day Last follow-up date - 2028 Year 12 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070269

Disclaimer: Curated by HT Syndication.