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A clinical research to assess correlation between transverse abdominal muscle contraction and pelvic floor muscle contraction in female subjects with stress urinary incontinence under pelvic floor muscle contraction condition

A clinical research to assess correlation between transverse abdominal muscle contraction and pelvic floor muscle contraction in female subjects with stress urinary incontinence

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The average age (SD) at baseline for Full Analysis Set (FAS) was 35.3 (9.3) years, the average weight was 52.5 (6.9) kg, the average body mass index (BMI) was 21.2 (2.4) kg/m^2, the average body fat was 30.1 (4.6) % and the average abdominal circumference was 77.3 (7.0) cm.

Informed consent was obtained from 43 female subjects with stress urinary incontinence. 31 subjects were eligible and included into the Safety Analysis Set (SAF). One of the 31 eligible subjects was excluded from the FAS due to no measurement.

No adverse event was reported.

The estimates of correlation coefficient between pelvic floor muscles (PFM) contraction and transverse abdominal muscles (TrA; right, left) contraction in electromyography (EMG) were 0.381 and 0.393 for standing, 0.490 and 0.443 for kegel, respectively. Ad-hoc analyses of EMG were performed on the visually corrected data in subjects who did not start the EMG measurement at planned time point and on the data excluded subjects who had clearly unmeasurable data. There were no note-worthy differences observed in these 2 ad-hoc analyses.

- There was a slight correlation in the contraction of the PFM and TrA in female subjects with stress urinary incontinence based on the scatter plot and correlation coefficient estimates. - No adverse event was reported. The product in this clinical research was well tolerated.

Feb. 28, 2022

No

Access to anonymized individual participant level data will not be provided for this trial as it meets one or more of the exceptions described on www.clinicalstudydatarequest.com under "Sponsor Specific Details for Astellas".

https://jrct.mhlw.go.jp/latest-detail/jRCT1070200115

Kimura En

Astellas Pharma Inc.

2-5-1, Nihonbashi-Honcho, Chuo-ku, Tokyo

clinicaltrialregistration@astellas.com

Center Information Medical

Astellas Pharma Inc.

2-5-1, Nihonbashi-Honcho, Chuo-ku, Tokyo

+81-120-189-371

clinicaltrialregistration@astellas.com

Complete

April. 09, 2021

Interventional

single arm study

open(masking not used)

uncontrolled control

single assignment

basic science

1. Subject has a clinical diagnosis of stress urinary incontinence, confirmed by a positive cough stress test or pad test at screening.
2. Subject has a body mass index range of 18.5 to 25.0 kg/m^2, inclusive.
3. Subject must either:
i. Be of non-childbearing potential:
a. Postmenopausal (defined as at least 1 year without any menses for which there is no other obvious pathological or physiological cause) prior to screening, or
b. Documented surgically sterile (e.g., hysterectomy, bilateral salpingectomy, bilateral oophorectomy).
ii. Or, if of childbearing potential:
a. Agrees not to try to become pregnant during the study
b. And agrees to have a urine pregnancy test on screening and test visit.
c. And have a negative urine pregnancy test at the screening visits
d. And agrees to consistently use 1 form of highly effective birth control in the case of having heterosexual intercourse starting at screening and throughout the study period
4. Subject can contract pelvic floor muscles and it should be confirmed by ultrasound at screening and test date.
5. Subject agrees not to participate in another interventional study while participation in the present study.

1. Subject underwent abdominal surgery at any time prior to screening. A prior caesarian section is allowed if performed more than 12 months prior to screening.
2. Any invasive procedures or surgery involving the pelvis and urinary tract, including bladder surgery (e.g., bladder augmentation or reduction surgery, latissimus dorsi detrusor myoplasty), pelvic organ prolapse surgery, and implant surgery for incontinence (e.g., tape, sling or artificial sphincter) at any time prior to screening.
3. Subject underwent pelvic radiation therapy at any time prior to screening.
4. Subject is using prohibited medications, or subject is using restricted medications under conditions different to those specified in the concomitant medication section.
5. Injection based treatment with botulinum toxin in the pelvis, bladder and/or abdominal muscles in the past 12 months.
6. Subject has a known diagnosis of pure urge incontinence, incontinence due to surgical treatment, or any significant voiding dysfunction (including nocturnal enuresis).
7. Subject has a known diagnose of a Chronic Pelvic Pain Syndrome e.g.,Bladder Pain Syndrome / Interstitial cystitis (BPS/IC).
8. Subject has any pain in the abdominal area that may affect outcomes, e.g., skin lesions, IBS, menstrual pain at Visit 2.
9. Subject has uterine prolapse >= Grade 2 Shaw's system (down to or outside the introitus), moderate or severe cystocele (reaches or protrudes outside the introitus).
10. Subject has a known diagnose of Diabetes Mellitus with related neuropathy.
11. Subject is known to have a Dermal Neuropathy like herpes zoster. And subject is known to have skin diseases or allergies at locations where electrodes will be attached. Local excision of skin lesions other than where the electrodes are attached is permitted.
12. Subject has clinical signs and symptoms of urinary tract infection, which is combined with a result of urine test (e.g., positive urine test by dipstick test).
13. Subject is known to have severe/complete SUI, i.e., subject is not able to hold urine.
14. Subject has a known neurologic disease or a defect affecting bladder function (e.g, neurogenic bladder, systemic or central neurological disease, such as Multiple Sclerosis or Parkinson's disease).
15. Subject has a known disease which is potentially responsible for incontinence known from medical history. This includes cardiac failure, chronic renal failure, uncontrolled diabetes, chronic obstructive pulmonary disease, stroke, dementia, general cognitive impairment, sleep disturbances (e.g., sleep apnea).
16. Subject is known to have diastasis recti abdominis and/or abdominal herniation (including inguinal, umbilical, femoral, and/or epigastric hernia).
17. Subject is known to have any condition, which makes the subject unsuitable for study participation.
18. Subject is employee of the Astellas Group, third parties associated with the study, or the clinical study site team.
19. Subject has received investigational therapy within 28 days or 5 times the half-live, whichever is longer, prior to screening.

Female

stress urinary incontinence

This study consists of two visits. After obtaining the informed consent from subjects, prespecified clinical test will be carried out in eligible subjects (Visit 1). On Visit 2, contractions of the transverse abdominal muscles and the pelvic floor muscles will be measured with electromyograph under pelvic floor muscles contraction condition. This measurement can be completed on Visit 1.

Contraction data of the transverse abdominal muscles and the pelvic floor muscles obtained from electromyograph

+81-92-283-7701

Mar. 19, 2021

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