None listed
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male and female aged 18 to 65 years old; 2. Normal defecation within 6 months before enrollment: stool frequency 3 times / week, stool form type in Bristol 3~5 and type Bristol 4 for more than 3/4 of the time, daily defecation volume>35g and <200g, defecation time <10 minutes, no defecation straining, no sense of incomplete evacuation and anorectal obstruction, never defecate with hand assisting, no bowel related abdominal pain, no fecal incontinence; 3. Normal physical examination (including DRE); 4. Not taking any medication within 1 month before enrollment; 5. Able and willing to provide signed informed consent.
Exclusion criteria
Exclusion criteria: 1. History of digestive diseases and no related symptoms except acute appendicitis and acute gastroenteritis; 2. History of lower urinary tract and reproductive system diseases, history of associated symptoms; 3. Surgery of gastrointestinal tract (including anorectum) and genitourinary system (appendectomy and cesarean is in exclusion); 4. History of pelvic trauma and lateral episiotomy in women; 5. Vaginal delivery times more than two times in women; 6. History of endocrine or metabolic diseases including diabetes and thyroid diseases, history of connective tissue disease, neurological diseases, psychiatric disorders and organ failure; 7. Pregnant or lactating women; 8. Participated in other clinical trials within 3 months before enrollment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| rectal defecation pressure;?rst sensation threshold volume;anal defecation pressure;Percent Anal Relaxation [Bear Down frame];Maximum Squeeze Pressure;Anal Residual (relaxation) Pressure [Bear Down frame];Verge to HPZ(High Pressure Zone) Max;anal sphincter pressure when coughing;maximum tolerable volume;Presence or absence of rectoanal inhibitory reflex;desire to defecate threshold volume;Rectoanal Pressure Differential;urge to defecate threshold volume;Length of High Pressure Zone (anorectal sphincter);anal resting pressure;Rectal Compliance;rectal resting pressure; | — |
Countries
China