Back to resultsEfficacy of Conservative Treatment of Functional Defecatory Disorders in Females With Pelvic Organ Prolapse
Primary Purpose
Pelvic Floor Prolapse, Functional Constipation, Rectocele
Status
Recruiting
Phase
Phase 3
Locations
Russian Federation
Study Type
Interventional
Intervention
Biofeedback therapy
Tibial neuromodulation
Pelvic floor muscles training
Diet modification
Sponsored by
About this trial
This is an interventional treatment trial for Pelvic Floor Prolapse focused on measuring pelvic floor prolapse, conservative treatment, functional disorders of defecation, rectocele, diet modification, biofeedback therapy, tibial neuromodulation
Eligibility Criteria
Inclusion Criteria:
- Willingness to participate (signed informed consent form)
- Females with rectocele I-II grade or rectocele I-II grade and internal rectal invagination and functional defecatory disorders (per Rome IV guidelines) confirmed on the basis of complex examination including high-resolution anorectal manometry
Exclusion Criteria:
- rectocele III grade;
- internal genitals prolapse;
- history of abdominal or pelvic surgery that may impact bowel motility (excluding non-complicated appendectomy or laparoscopic cholecystectomy);
- gynecological surgery that may influence sensory or reservoir function of rectum;
- history of major cardiovascular events, or presence of current conditions that in case of participation of the patient in the study may put her at risk of exacerbation or complication;
- start of any new concomitant medication with mechanisms of action that influence rectal motility, sensory function, muscle tone and/or contractility
- inability to understand and/or follow the instructions to perform all the procedures required per protocol
- general condition of the patient that make her ineligible by the discretion of the investigator
Sites / Locations
- Federal State Budgetary Scientific Institution "Federal Research Centre of Nutrition, BiotechnologyRecruiting
- Federal Research Center of ColoproctologyRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
biofeedback and tibial neuromodulation (BFB+TNM)
BFB+TNM + pelvic floor muscles training (PFMT)
BFB+TNM+PFMT+diet modification
Arm Description
Outcomes
Primary Outcome Measures
Mean stool frequency
clinical outcome
Mean stool form value
clinical outcome, assessed with the use of the Bristol stool scale (BSS)
Mean defecation with difficult bowel emptying
patient-reported outcome, clinical
Change of KESS scale points
A specialized validated questionnaire will be used before treatment and at the end of the study. "Change" is to be assessed as percentage decline from baseline values.
Change in Scale of bowel evacuatory function assessment
A specialized validated questionnaire will be used before treatment and at the end of the study. "Change" is to be assessed as percentage decline from baseline v
Average anal resting pressure
Values obtained during HR anorectal manometry
Maximum absolute anal squeeze pressure
Values obtained during HR anorectal manometry
Average absolute anal squeeze pressure
Values obtained during HR anorectal manometry
Average incremental anal squeeze pressure
Values obtained during HR anorectal manometry
Residual push pressure
Values obtained during HR anorectal manometry
Push relaxation percentage
Values obtained during HR anorectal manometry
Secondary Outcome Measures
Full Information
NCT ID
NCT04547816
First Posted
September 1, 2020
Last Updated
April 10, 2023
Sponsor
Federal State Budgetary Scientific Institution "Federal Research Centre of Nutrition, Biotechnology
Collaborators
State Scientific Centre of Coloproctology, Russian Federation, Ministry of Health, Russian Federation, Ministry of Science and Higher Education, Russian Federation
1. Study Identification
Unique Protocol Identification Number
NCT04547816
Brief Title
Efficacy of Conservative Treatment of Functional Defecatory Disorders in Females With Pelvic Organ Prolapse
Official Title
Evaluation of Complex (Physical Therapy and Diet) Treatment of Functional Defecatory Disorders in Females With Pelvic Organ Prolapse
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 1, 2020 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
March 3, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Federal State Budgetary Scientific Institution "Federal Research Centre of Nutrition, Biotechnology
Collaborators
State Scientific Centre of Coloproctology, Russian Federation, Ministry of Health, Russian Federation, Ministry of Science and Higher Education, Russian Federation
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This study is planned to evaluate the efficacy of complex conservative treatment (including tibial neuromodulation, biofeedback therapy, special pelvic floor training and diet modification) in women with pelvic organ prolapse
Detailed Description
Pelvic organ prolapse is a condition with impaired anatomic structure, which may result in defecatory disorders and usually considered as an indication for surgery. However, operation is not always possible. Existing data suggest that functional component may also be possible, despite on the anatomic impairment. The aim of the study is to evaluate the effect of complex conservative treatment of functional defecatory disorders in patients with mild to moderate grade of pelvic organ prolapse
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pelvic Floor Prolapse, Functional Constipation, Rectocele
Keywords
pelvic floor prolapse, conservative treatment, functional disorders of defecation, rectocele, diet modification, biofeedback therapy, tibial neuromodulation
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
Random assignment to one of the groups depending on the treatment options:
biofeedback and tibial neuromodulation
biofeedback and tibial neuromodulation + pelvic floor muscles training
biofeedback and tibial neuromodulation + pelvic floor muscles training + diet modification
Masking
InvestigatorOutcomes Assessor
Masking Description
After randomization eligible subjects are to receive one of the treatment option described in the Model Description according to the order placed in a closed envelope which is to be opened by person who perform biofeedback (BFT) and tibial neuromodulation (TNM). The investigator responsible for the study conduction, clinical assessment and high-resolution anorectal manometry measurements is not supposed to get the information about the number of procedures (BFT+TNM; or BFT+TNM + pelvic floor muscles training (PFMT); or BFT+TNM + PFMT + diet modification (DM)) that a certain subject receives
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
biofeedback and tibial neuromodulation (BFB+TNM)
Arm Type
Experimental
Arm Title
BFB+TNM + pelvic floor muscles training (PFMT)
Arm Type
Experimental
Arm Title
BFB+TNM+PFMT+diet modification
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
Biofeedback therapy
Other Intervention Name(s)
BFB
Intervention Description
Biofeedback therapy is a procedure when the patient is taught to make proper squeezing by adequate increase of intra-abdominal and rectal pressures and relaxation of the muscles of the pelvic floor. This procedure is widely described and is to be performed with the use of devices registered for this purpose Urostim and WPM Solar, MMS, the Netherlands
Intervention Type
Procedure
Intervention Name(s)
Tibial neuromodulation
Other Intervention Name(s)
TNM
Intervention Description
TNM is a standard procedure that is previously described as an effective method to treat functional insufficiency of the anal sphincter. It acts on the lumbosacral nerve plexus with an electric current through the posterior tibial nerve of one of the patient's limbs. For the study purpose a registered device for electric therapy (BioBravo, MTR Plus Vertriebs GmbH, Germany) is to be used.
Intervention Type
Behavioral
Intervention Name(s)
Pelvic floor muscles training
Other Intervention Name(s)
PFMT
Intervention Description
PFMT is a complex of 5 exercises aimed to make functional training of pelvic floor muscles. This complex does not require additional equipment. It may be performed at home. The patients will be trained to perform this complex of exercises by a healthcare provider.
The complex of physical therapy consists of a single basic exercise for training coordinated muscle tension of abdominal wall and relaxation of the pelvic floor muscles, and 4 exercises to increase the contractility of pelvic floor muscles without additional involvement of the muscles of the abdominal wall. This allows to coordinate and consciously control the contraction and relaxation of the pelvic diaphragm. Initial course of training is 10 working days. Than patients continue the intervention for 6 months at home with online monitoring of the correctness and regularity of training.
Intervention Type
Behavioral
Intervention Name(s)
Diet modification
Other Intervention Name(s)
DM
Intervention Description
Diet modification play an important role in the regulation of colonic transit and defecation. Dietary factors may act through faecal bulk by additional stimulation of mechanoreceptors of the rectum. At the same time, adequate intake of vitamins (for example, B12) may improve electric conductivity of nerves and thus impact the tone of pelvic floor muscles. Among other factors known to affect functional state of pelvic floor muscles and colonic transit are dietary fibers, adequate intake of water, regular meal intake. For the study purposes, it is planned to provide standard recommendation based on the national recommended daily allowances according to patients' sex, age and physical activity level.
Primary Outcome Measure Information:
Title
Mean stool frequency
Description
clinical outcome
Time Frame
A week
Title
Mean stool form value
Description
clinical outcome, assessed with the use of the Bristol stool scale (BSS)
Time Frame
A week
Title
Mean defecation with difficult bowel emptying
Description
patient-reported outcome, clinical
Time Frame
a week
Title
Change of KESS scale points
Description
A specialized validated questionnaire will be used before treatment and at the end of the study. "Change" is to be assessed as percentage decline from baseline values.
Time Frame
at the end-point, 6 months after enrolment
Title
Change in Scale of bowel evacuatory function assessment
Description
A specialized validated questionnaire will be used before treatment and at the end of the study. "Change" is to be assessed as percentage decline from baseline v
Time Frame
at the end-point, 6 months after enrolment
Title
Average anal resting pressure
Description
Values obtained during HR anorectal manometry
Time Frame
at the end-point, 6 months after enrolment
Title
Maximum absolute anal squeeze pressure
Description
Values obtained during HR anorectal manometry
Time Frame
at the end-point, 6 months after enrolment
Title
Average absolute anal squeeze pressure
Description
Values obtained during HR anorectal manometry
Time Frame
at the end-point, 6 months after enrolment
Title
Average incremental anal squeeze pressure
Description
Values obtained during HR anorectal manometry
Time Frame
at the end-point, 6 months after enrolmentat the end-point, 6 months after enrolment
Title
Residual push pressure
Description
Values obtained during HR anorectal manometry
Time Frame
at the end-point, 6 months after enrolment
Title
Push relaxation percentage
Description
Values obtained during HR anorectal manometry
Time Frame
at the end-point, 6 months after enrolment
10. Eligibility
Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Willingness to participate (signed informed consent form)
Females with rectocele I-II grade or rectocele I-II grade and internal rectal invagination and functional defecatory disorders (per Rome IV guidelines) confirmed on the basis of complex examination including high-resolution anorectal manometry
Exclusion Criteria:
rectocele III grade;
internal genitals prolapse;
history of abdominal or pelvic surgery that may impact bowel motility (excluding non-complicated appendectomy or laparoscopic cholecystectomy);
gynecological surgery that may influence sensory or reservoir function of rectum;
history of major cardiovascular events, or presence of current conditions that in case of participation of the patient in the study may put her at risk of exacerbation or complication;
start of any new concomitant medication with mechanisms of action that influence rectal motility, sensory function, muscle tone and/or contractility
inability to understand and/or follow the instructions to perform all the procedures required per protocol
general condition of the patient that make her ineligible by the discretion of the investigator
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sergey Morozov, MD, PhD
Phone
+79104681801
Email
morosoffsv@mail.ru
First Name & Middle Initial & Last Name or Official Title & Degree
Oksana Fomenko, MD, PhD
Phone
+79164817323
Email
oksana671@yandex.ru
Facility Information:
Facility Name
Federal State Budgetary Scientific Institution "Federal Research Centre of Nutrition, Biotechnology
City
Moscow
ZIP/Postal Code
115446
Country
Russian Federation
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sergey Morozov, MD, PhD
Phone
+79104681801
Email
morosoffsv@mail.ru
First Name & Middle Initial & Last Name & Degree
Marina Biryukova, MD
Phone
+74997943572
Email
bibi24@yandex.ru
First Name & Middle Initial & Last Name & Degree
Marina Biryukova, MD
Facility Name
Federal Research Center of Coloproctology
City
Moscow
Country
Russian Federation
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Oksana Fomenko, MD, PhD
Phone
+79164817327
Email
oksana671@yandex.ru
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Time Frame
within 2 years after study completion
IPD Sharing Access Criteria
per request
IPD Sharing URL
http://ion.ru
Learn more about this trial
Efficacy of Conservative Treatment of Functional Defecatory Disorders in Females With Pelvic Organ Prolapse
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