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Comparing the effect of biofeedback combined with N-acetylcysteine ??in improving pelvic floor dysfunction

Biofeedback combined with N-acetylcysteine in comparison to biofeedback alone in treatment of pelvic floor dysfunction: a randomized clinical trial

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20240311061259N5
Enrollment
100
Registered
2025-12-01
Start date
2025-12-01
Completion date
Unknown
Last updated
2025-12-08

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

Conditions

Pelvic floor dysfunction. Pelvic muscle wasting

Interventions

Intervention 1: Intervention group: This group will receive 8 sessions of biofeedback therapy along with daily intake of 600 mg of N-acetylcysteine ??(Actover Company). Intervention 2: Control group:

Sponsors

Shahid Beheshti University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: Age 18 to 65 years Diagnosis of pelvic floor dysfunction based on specialist examination and confirmation of the standard Pelvic Floor Distress Disorders-20 questionnaire Mild to moderate severity of pelvic floor dysfunction Ability to attend biofeedback therapy sessions and regular use of N-acetylcysteine ??supplementation Willingness to participate in the study and signing an informed consent form No drug treatment or biofeedback therapy in the past three months

Exclusion criteria

Exclusion criteria: Having neurological or muscular diseases that affect pelvic floor function (such as MS, Parkinson's, or uncontrolled diabetes) History of pelvic or abdominal surgery within the past six months Moderate to severe renal or hepatic impairment Moderate to severe renal or hepatic impairment Pregnancy or breastfeeding

Design outcomes

Primary

MeasureTime frame
Severity of pelvic floor muscle disorder symptoms. Timepoint: Before the intervention and 3 months after the intervention. Method of measurement: Pelvic floor muscle disorder questionnaire-20.

Secondary

MeasureTime frame
Health-related quality of life. Timepoint: Before the intervention and 3 months after the intervention. Method of measurement: SF-36 questionnaire.;N-Acetylcysteine ??Side Effects. Timepoint: 3 Months After Intervention. Method of measurement: History and clinical interview.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactElnaz Zarinzadeh

Shahid Beheshti University of Medical Sciences

zarinzadeh.elnaz@yahoo.com+98 21 2243 2526

Outcome results

None listed

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