Skip to content

Study on the safety and effectiveness of standardized ketogenic diet intervention in the treatment of obese women with stress urinary incontinence

Study on the safety and effectiveness of standardized ketogenic diet intervention in the treatment of obese women with stress urinary incontinence

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000041252
Enrollment
Unknown
Registered
2020-12-23
Start date
2021-01-31
Completion date
Unknown
Last updated
2021-03-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stress urinary incontinence

Interventions

Sponsors

Beijing Shijitan Hospital
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
40 Years to 60 Years

Inclusion criteria

Inclusion criteria: (1) Aged 40-60 years; (2) BMI >= 28 kg/m2; (3) When the abdominal pressure increases, such as sneezing, coughing, laughing or exercising, involuntary urine leaks from the urethral orifice; (4) 1h urine pad test >= 2 g; (5) Those who voluntarily participate in clinical trials and sign informed consent.

Exclusion criteria

Exclusion criteria: (1) Urgency urinary incontinence, overflow urinary incontinence and mixed urinary incontinence; (2) History of urinary incontinence or pelvic floor surgery; History of total hysterectomy or subtotal hysterectomy; (3) History of pelvic radiotherapy; (4) Pelvic organ prolapse; (5) Urinary infection; Urinary calculi; Urinary tuberculosis; (6) 1 h urine pad test >= 10g; (7) receiving treatment for SUI or taking drugs that affect bladder function; (8) Limited activities, such as walking, climbing stairs and running; (9) Chronic cough, constipation; (10) During lactation or pregnancy, there is a pregnancy plan in the intervention period of this study; (11) Those with serious primary diseases such as heart, liver, kidney, hematopoietic system and other important organs and systems; Myasthenia gravis; Periodic paralysis; (12) Contraindications of ketogenic diet: A. Metabolic contraindications: carnitine deficiency, carnitine palmitoyl transferase I or II deficiency, carnitine transferase II deficiency, ß-oxidase deficiency, short chain acyl dehydrogenase deficiency, long chain 3- hydroxyacyl coenzyme deficiency, medium chain 3- hydroxyacyl coenzyme deficiency, pyruvate hydroxylase deficiency, porphyria; B. Combined contraindications: urinary calculi, history of renal failure or severe renal insufficiency, familial dyslipidemia, severe liver diseases, chronic metabolic acidosis, pancreatic history, severe diabetes, active gallbladder diseases, fat digestion disorders, severe cardiovascular and cerebrovascular diseases, etc.; C. Contraindications of oral drugs: Antiepileptic drugs such as penicillamine, tolbutamide and acetazolamide can cause acidosis, and treatment with ketogenic diet will aggravate acidosis; D. Taboo in special conditions: pregnant, breastfeeding, infected, eating difficulties, and uncooperative patients.

Design outcomes

Primary

MeasureTime frame
Urine leakage;

Secondary

MeasureTime frame
BMI;Body fat rate;Abdominal circumference;incontinence impact questionnaire short form, IIQ-7;ICIQ-SF;

Countries

China

Contacts

Public ContactWenpei Bai

Beijing Shijitan Hospital

bwp66@163.com+86 13366157805

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026