Research of Pelvic Floor Electrical Stimulation for Defecation and Urination Dysfunction in Patients with Multiple System Atrophy

• Register: ChiCTR
• Last refreshed on: 19 December 2023
• Main ID: ChiCTR2100046394
• Date of registration: 2021-05-15
• Prospective Registration: Yes
• Primary sponsor: Xuanwu Hospital, Capital Medical University
• Public title: Research of Pelvic Floor Electrical Stimulation for Defecation and Urination Dysfunction in Patients with Multiple System Atrophy
• Scientific title: Research of Pelvic Floor Electrical Stimulation for Defecation and Urination Dysfunction in Patients with Multiple System Atrophy
• Date of first enrolment: 2021-06-01
• Target sample size: Experimental group:50;
• Recruitment status: Completed
• URL: https://www.chictr.org.cn/showproj.html?proj=123483
• Study type: Interventional study
• Study design: Single arm
• Phase: N/A

Countries of recruitment

China

Contacts

• Name: Cao Gan
• Affiliation: Xuanwu Hospital, Capital Medical University

• Name: Cao Gan
• Affiliation: Xuanwu Hospital, Capital Medical University

Key inclusion & exclusion criteria

Inclusion criteria: 1. Possible shrinkage of multiple systems.
2. Has symptoms of frequent urination and urgency without treatment.
3. Accepted urology-neurology diagnosis and treatment, followed up for 2 weeks.
4. Bladder ultrasound: residual urine <= 50mL.
5. Aged >= 30 years and <= 75 years.
6. The overall disability level is 1, 2, and 3.
7. Urine routine bacteria (-).
8. Male urodynamic force: 20cmH2O <= detrusor contraction force <= 60cmH2O, maximum free urine flow rate <= 10 mL/s; female urodynamic force: detrusor contraction force exists, and maximum free urine flow rate <= 10 mL/s.
Exclusion criteria: 1. Cannot urinate at all.
2. Language: severely affected, often (more than half of the time) asked to repeat the statement; or in most cases unable to understand.
3. Swallowing: obviously abnormal, frequent food inhalation; or nasal feeding or gastrostomy.
4. Walking: severe abnormality, often needs assistance and/or assistive tools from others; or unable to walk even with assistance.
5. Lung infection (chest X-ray or CT).
6. Stress urinary incontinence.
7. There are sequelae of cerebral infarction.
8. History of previous urethral surgery.
9. Impaired renal function.
10. Male patients with benign prostatic hyperplasia.
11. Drug treatment contraindications:
(1) Patients with urinary retention, gastric stagnation, and uncontrolled narrow-angle glaucoma;
(2) Patients who have been confirmed to have allergic reactions to this product;
(3) Patients with myasthenia gravis, patients with severe ulcerative colitis, and patients with toxic megacolon.
12. Electrical stimulation contraindications: use of a pacemaker, pregnancy, undiagnosed pain symptoms, undiagnosed skin, vaginal and anal diseases, skin under anesthesia or desensitization, urinary tract infection or vaginal infection is being treated recently, the irritated part is suffering from disease, the damaged tissue of the irritated part is being cured, diabetes or high blood pressure, abnormal cervical smear examination.

Age minimum: 30
Age maximum: 75
Gender: Both

Health Condition(s) or Problem(s) studied

multiple system atrophy

Intervention(s)

Experimental group:Drug (tolterodine) combined with electrical stimulation;

Primary Outcome(s)

Subjective urination score;

Secondary Outcome(s)

International prostatesymptom score;Overactive bladder score;

Source(s) of Monetary Support

self-funded

Ethics review

Status: Approved
Approval date: 30/11/2022
Contact:

Shen Qian

[phone]