Cells treatment for female patients with urinary problems.

Culture expanded satellite cells/myoblasts for the treatment of urinary incontinence in female patients with urethral sphincter insufficiency.

Status

Recruiting

Phases

Phase 1

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2021/10/037120

Enrollment

Registered

2021-10-06

Start date

Unknown

Completion date

Unknown

Last updated

2023-01-09

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

Conditions

Health Condition 1: N393- Stress incontinence (female) (male)

Interventions

Intervention1: Cultured Autologous skeletal muscle derived stem cells transplantation into urethral sphincter.: 25-200x106 cells will be injected one centimetre distal to the bladder neck cystoscopica

Eligibility

Inclusion criteria

Inclusion criteria: Female patients with bothersome stress urinary incontinence who have failed conservative therapy will be included in this study.

Exclusion criteria

Exclusion criteria: Patients who have an underlying neurological lesion, history of radiation exposure, concomitant prolapse [stage 2 or more anterior compartment] or persistent high post-void residue will not be included in the study.

Design outcomes

Primary

Measure	Time frame
Measuring improvement in functional status of patient based on improvement in Stamey grade of incontinence, bladder diary, and pad test.Timepoint: Baseline and at 3, 6, 9 and 12 months post procedure	—

Secondary

Measure	Time frame
Subjective incontinence assessment and Quality of life assessment (using ICIQ-SF questionnaire),assessment of urethral volume on MRI assessment and Urodynamic assessmentTimepoint: Baseline and at 12 months follow up	—

Countries

India

Contacts

Public ContactAnuj Deep Dangi

Christian Medical College and Hospital, Vellore.

anujdeepdangi@gmail.com

Outcome results

None listed

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