Investigating pelvic floor training as a treatment for severe bloating in gastrointestinal disorders

Investigating pelvic floor biofeedback as a treatment for severe bloating in functional gastrointestinal disorders with outlet dysfunction

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

ISRCTN

Registry ID

ISRCTN17004079

Enrollment

180

Registered

2021-01-08

Start date

2017-03-01

Completion date

Unknown

Last updated

2021-10-04

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

Conditions

Bloating treatment in functional gastrointestinal disorders Digestive System Functional gastrointestinal disorders

Interventions

All patients are screened for the severity of bloating that is their main complaint and diagnosed according to Rome III criteria for FGIDs. If the bloating is > 24 mm on 0-100 mm-VAS scale they underg

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Aged between 18 and 75 years 2. Able to understand and the willingness to comply with the study procedures 3. Average daily abdominal bloating score =24 on a 100-mm VAS with/without visible abdominal distension

Exclusion criteria

Exclusion criteria: 1. Pregnancy 2. Serious, or unstable medical condition 3. Insulin-dependent diabetes mellitus 4. Major psychiatric diagnosis 5. Endocrine diseases 6. History of eating disorders 7. History of drug or alcohol abuse 8. Previous abdominal surgery, except appendectomy or cholecystectomy

Design outcomes

Primary

Measure	Time frame
1. Response to diet intervention or pelvic floor biofeedback treatment (BT) measured using patient response to the question: “Compared to the interval preceding the treatment (diet intervention or biofeedback) how would you score your bloating improvement: worse (0), no improvement (1), mild (2), fair (3), or major improvement/cure (4)?", where all patients reporting fair or major improvement/cure will be considered as responding, measured at 2 weeks , and 1, 3, and 6 months after BT	—

Measure

Time frame

1. Response to diet intervention or pelvic floor biofeedback treatment (BT) measured using patient response to the question: “Compared to the interval preceding the treatment (diet intervention or biofeedback) how would you score your bloating improvement: worse (0), no improvement (1), mild (2), fair (3), or major improvement/cure (4)?", where all patients reporting fair or major improvement/cure will be considered as responding, measured at 2 weeks , and 1, 3, and 6 months after BT

—

Secondary

Measure	Time frame
1. Effect of diet intervention on bloating severity measured using a 0-100 visual analogue scale (VAS), and abdominal girth (using a belt around the abdomen at standardized sites) at baseline and 2 weeks 2. Effect of diet intervention and pelvic floor biofeedback treatment (BT) on quality of life changes measured using the Short Form 36 (SF36) at 2 weeks and after BT 3. Effect of pelvic floor biofeedback treatment (BT) on bloating severity measured using a 0-100 visual analogue scale (VAS), balloon expulsion test (BET), and electromyography (EMG) testing on straining at 2 weeks (before BT), and then 1, 3, and 6 months after BT	—

Measure

Time frame

1. Effect of diet intervention on bloating severity measured using a 0-100 visual analogue scale (VAS), and abdominal girth (using a belt around the abdomen at standardized sites) at baseline and 2 weeks 2. Effect of diet intervention and pelvic floor biofeedback treatment (BT) on quality of life changes measured using the Short Form 36 (SF36) at 2 weeks and after BT 3. Effect of pelvic floor biofeedback treatment (BT) on bloating severity measured using a 0-100 visual analogue scale (VAS), balloon expulsion test (BET), and electromyography (EMG) testing on straining at 2 weeks (before BT), and then 1, 3, and 6 months after BT

—

Countries

Italy

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 14, 2026