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

Not Applicable

Completed

• Conditions: Bloating treatment in functional gastrointestinal disorders; Digestive System; Functional gastrointestinal disorders

• Registration Number: ISRCTN17004079
• Lead Sponsor: niversity of Salerno

Brief Summary

2021 Results article in https://pubmed.ncbi.nlm.nih.gov/34532928/ (added 21/09/2021)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2019-06-30
• Study Start: 2021-01-08
• Last Update Posted: 4 October 2021

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 180

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

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

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
<br> 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<br> 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<br> 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<br>