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

ISRCTN ISRCTN17004079
DOI https://doi.org/10.1186/ISRCTN17004079
Secondary identifying numbers Studio FgiD
Submission date
30/12/2020
Registration date
08/01/2021
Last edited
21/09/2021
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Digestive System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Background and study aims
The cause of bloating, one of the most common and bothersome complaints in patients with functional gastrointestinal disorders (FGIDs), is complicated and partially understood.

The aim of this study is to investigate, in patients with severe bloating, the relationship between the defecation pattern, the severity of bloating, and the abdominal size changes, and the effectiveness of biofeedback treatment on bloating. Biofeedback training involves using electrical sensors to train

Who can participate?
Patients with FGIDs reporting bloating as their main complaint.

What does the study involve?
Participants will undergo a measurement of abdominal size (girth) using a belt around the abdomen. Participants will also be provided with dietary management with NICE advice with the addition of a lactose-free diet for two weeks. Over the two week period, participants will be asked complete a daily diary to assess their bowel function and to record girth at fasting (before eating) and two hours after lunch.

After two weeks of following diet changes, participants will be asked to fill in a questionnaire on the improvement of their bloating and abdominal girth measurements two hours after a meal.

Patients who do not report fair or major improvement at two weeks will undergo a standardized test. This will be the balloon expulsion test (BET) which uses a balloon to simulate a bowel movement and is scored as successful if the balloon is evacuated within two minutes.

Furthermore, participants will be invited to take part in biofeedback training provided at single center located in Verona, Northern Italy. This training has been previously validated for constipation due to dyssynergic defecation (DD) and will be provided by a registered nurse. The aim of this training is to improve the effort used during defecation with the purpose of relieving bloating. To confirm the diagnosis of outlet dysfunction, all the subjects allocated to biofeedback training will undergo an evaluation of pelvic floor muscle function on straining using electromyography (EMG) testing. EMG testing uses electrodes to stimulate the pelvic muscle to measure electrical activity.

Clinical visits will occur 1, 3, and 6 months after treatment. During these visits, patients will be required to answer the questionnaires on their bloating that were completed after two weeks, and undergo physiological testing (BET and EMG evaluation).

What are the possible benefits and risks of participating?
There is a possible beneficial effect of biofeedback training on bloating. There are no anticipated risks for taking part in this study.

Where is the study run from?
University of Salerno (Italy)

When is the study starting and how long is it expected to run for?
From December 2015 to June 2019

Who is funding the study?
Investigator initiated and funded

Who is the main contact?
Prof Paola Iovino
piovino@unisa.it

Contact information

Prof Paola Iovino
Scientific

Gastrointestinal Unit
Department of Medicine, Surgery and Dentistry
Scuola Medica Salernitana
University of Salerno
S. Allende
Baronissi
University Hospital "San Giovanni di Dio e Ruggi D'Aragona"
Piazzale Ippocrate 1
Salerno
84100
Italy

ORCiD logoORCID ID 0000-0002-9568-0680
Phone +39 ‭335 7822672‬‬‬‬
Email piovino@unisa.it

Study information

Study designMulticenter observational cohort study
Primary study designObservational
Secondary study designCohort study
Study setting(s)Hospital
Study typeTreatment
Participant information sheet Not available in web format, please use contact details to request a participant information sheet
Scientific titleInvestigating pelvic floor biofeedback as a treatment for severe bloating in functional gastrointestinal disorders with outlet dysfunction
Study objectives1. Bloating and abdominal distension could be secondary to impaired gas or non-gas emptying possibly due to disordered defecation
2. Pelvic floor biofeedback is an effective treatment for severe bloating in functional gastrointestinal disorders with outlet dysfunction
Ethics approval(s)Approved 06/05/2013, revision approved 13/06/2019, Ethical Commitee-Azienda Sanitaria Locale Napoli 3 Sud (Via Marconi 66, Torre del Greco, Napoli, 80049, Italy), ref: n°3/2013, revised approval ref: 0089264
Health condition(s) or problem(s) studiedBloating treatment in functional gastrointestinal disorders
InterventionAll 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 undergo a girth measurement abdominal girth measured by a belt around the abdomen at standardized sites and start 2 weeks of dietary management with NICE advice with the addition of lactose-free diet and complete a daily diary to assess bowel function as well as record girth measurements at fasting and 2 hours after lunch.

After two weeks at the first visit, participants will be asked to fill in a questionnaire on the subjective improvement of bloating on a 5-point Likert scale (worse to major improvement), a further assessment of abdominal bloating (using a 0-100 visual analogue scale), and abdominal girth measurements 2 h after a meal. Patients who did not report fair or major improvement/cure will undergo a standardized balloon expulsion test (BET) which will be scored as either successful or failed if the balloon could not be evacuated within 2 min. Furthermore, they will invited to take part in a biofeedback protocol to improve the defecation effort with the purpose of ameliorating bloating that was provided at single center located in Verona, Northern Italy. To confirm the diagnosis of outlet dysfunction, all the subjects allocated to biofeedback will undergo a basal evaluation of pelvic floor muscle function on straining by pelvic floor electromyography (EMG) testing according to a previously described protocol. A registered nurse provided the BT previously validated for constipation due to dyssynergic defecation (DD). Clinical visits were scheduled at 1, 3, and 6 months post-treatment. During these visits patients will be required to answer a question on subjective perception of symptom improvement on a 5-point Likert scale (worse, no improvement, mild, fair, and major improvement/cure), will be assessed for bloating on the (0-100) VAS, and undergo physiological testing (BET and EMG evaluation).
Intervention typeBehavioural
Primary outcome measure1. 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 measures1. 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
Overall study start date01/10/2015
Completion date30/06/2019

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participants180 patients
Total final enrolment180
Key inclusion criteria1. 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
Key exclusion criteria1. 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
Date of first enrolment01/03/2017
Date of final enrolment30/06/2018

Locations

Countries of recruitment

  • Italy

Study participating centres

Gastrointestinal Unit, University Hospital "San Giovanni di Dio e Ruggi D'Aragona"
Piazzale Ippocrate 1
Salerno
84100
Italy
Pio Albergo Trivulzio Hospital
Via Trivulzio, 15
Milan
20146
Italy
S. Giovanni Addolorata Hospital
Via dell'Amba Aradam 9
Rome
00184
Italy
Division of Gastroenterology B, Azienda Ospedaliera Universitaria Integrata Verona
Piazzale Aristide Stefani, 1
Verona
37126
Italy

Sponsor information

University of Salerno
University/education

S. Allende
Baronissi
Salerno
84081
Italy

Phone +39 ‭335 7822672
Email piovino@unisa.it
Website http://www.unisa.it/
ROR logo "ROR" https://ror.org/0192m2k53

Funders

Funder type

Other

Investigator initiated and funded

No information available

Results and Publications

Intention to publish date31/12/2021
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryData sharing statement to be made available at a later date
Publication and dissemination planPlanned publication in a high-impact peer-reviewed journal.
IPD sharing planThe data sharing plans for the current study are unknown and will be made available at a later date.

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article 16/09/2021 21/09/2021 Yes No

Editorial Notes

21/09/2021: Publication reference added.
04/01/2021: Trial’s existence confirmed by Ethical Commitee-Azienda Sanitaria Locale Napoli 3 Sud.