Pelvic Floor ProlapsePhase 3NCT04547816
Efficacy of Conservative Treatment of Functional Defecatory Disorders in Females With Pelvic Organ Prolapse
A Phase 3 study testing Biofeedback therapy, Tibial neuromodulation and Pelvic floor muscles training in people with Pelvic Floor Prolapse and Functional Constipation, run by Federal State Budgetary Scientific Institution at 2 sites in Russia.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Pelvic Floor Prolapse, Functional Constipation, Rectocele
- What is being tested?
- Biofeedback therapy, Tibial neuromodulation and Pelvic floor muscles training
- Type of treatment
- Surgery or procedure, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 2 sitesRussia
- Study dates
- 1 Jul 2020to 31 May 2026
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Russia2 sites, 2 recruiting
- Recruiting
Federal State Budgetary Scientific Institution "Federal Research Centre of Nutrition, Biotechnology
Moscow, 115446
Sergey Morozov, MD, PhD, +79104681801, morosoffsv@mail.ru
Marina Biryukova, MD, +74997943572, bibi24@yandex.ru
- Recruiting
Federal Research Center of Coloproctology
Moscow
Oksana Fomenko, MD, PhD, +79164817327, oksana671@yandex.ru
About this study
Official title: Evaluation of Complex (Physical Therapy and Diet) Treatment of Functional Defecatory Disorders in Females With Pelvic Organ Prolapse
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
Read the 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
- Conditions
- Pelvic Floor Prolapse, Functional Constipation, Rectocele
- Being tested
- Biofeedback therapy, Tibial neuromodulation, Pelvic floor muscles training, Diet modification
- Keywords
- pelvic floor prolapse, conservative treatment, functional disorders of defecation, rectocele, diet modification, biofeedback therapy, tibial neuromodulation
- Medical subject headings
- Rectocele
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biofeedback therapyProcedure or surgery
Also called BFB
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
Tibial neuromodulationProcedure or surgery
Also called TNM
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.
Pelvic floor muscles trainingBehavioural
Also called PFMT
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.
Diet modificationBehavioural
Also called DM
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.
| Study group | Role | What they receive |
|---|---|---|
| biofeedback and tibial neuromodulation (BFB+TNM) | Experimental | Not described Receives: Procedure: Biofeedback therapy; Procedure: Tibial neuromodulation |
| BFB+TNM + pelvic floor muscles training (PFMT) | Experimental | Not described Receives: Procedure: Biofeedback therapy; Procedure: Tibial neuromodulation; Behavioral: Pelvic floor muscles training |
| BFB+TNM+PFMT+diet modification | Experimental | Not described Receives: Procedure: Biofeedback therapy; Procedure: Tibial neuromodulation; Behavioral: Pelvic floor muscles training; Behavioral: Diet modification |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean stool frequency
clinical outcome
Measured: A week
Mean stool form value
clinical outcome, assessed with the use of the Bristol stool scale (BSS)
Measured: A week
Mean defecation with difficult bowel emptying
patient-reported outcome, clinical
Measured: a week
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.
Measured: at the end-point, 6 months after enrolment
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
Measured: at the end-point, 6 months after enrolment
Average anal resting pressure
Values obtained during HR anorectal manometry
Measured: at the end-point, 6 months after enrolment
Maximum absolute anal squeeze pressure
Values obtained during HR anorectal manometry
Measured: at the end-point, 6 months after enrolment
Average absolute anal squeeze pressure
Values obtained during HR anorectal manometry
Measured: at the end-point, 6 months after enrolment
Average incremental anal squeeze pressure
Values obtained during HR anorectal manometry
Measured: at the end-point, 6 months after enrolmentat the end-point, 6 months after enrolment
Residual push pressure
Values obtained during HR anorectal manometry
Measured: at the end-point, 6 months after enrolment
Push relaxation percentage
Values obtained during HR anorectal manometry
Measured: at the end-point, 6 months after enrolment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2020
- Study start1 Jul 2020
- Primary completion31 Dec 2025 (estimated)
- Study completion31 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pelvic Floor ProlapseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Random assignment to one of the groups depending on the treatment options: 1. biofeedback and tibial neuromodulation 2. biofeedback and tibial neuromodulation + pelvic floor muscles training 3. biofeedback and tibial neuromodulation + pelvic floor muscles training + diet modification
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Federal State Budgetary Scientific Institution
- Sponsor type
- Other government
- Collaborators
- State Scientific Centre of Coloproctology, Russian Federation, Ministry of Health, Russian Federation, Ministry of Science and Higher Education, Russian Federation
- Responsible party
- Principal investigator, Sergey Morozov, Federal State Budgetary Scientific Institution
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04547816
- Sponsor's protocol ID
- DGH-SSCC1
- Status last verified
- Aug 2025
- First submitted
- 1 Sep 2020
- Last updated
- 3 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Complex (Physical Therapy and Diet) Treatment of Functional Defecatory Disorders in Females With Pelvic Organ Prolapse
- ClinicalTrials.gov ID
- NCT04547816
- Acronym / sponsor ID
- DGH-SSCC1
- Conditions
- Pelvic Floor Prolapse, Functional Constipation, Rectocele
- Keywords
- pelvic floor prolapse, conservative treatment, functional disorders of defecation, rectocele, diet modification, biofeedback therapy, tibial neuromodulation
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Federal State Budgetary Scientific InstitutionOther government
- Collaborators
- State Scientific Centre of Coloproctology, Russian Federation, Ministry of Health, Russian Federation, Ministry of Science and Higher Education, Russian Federation
- Study start
- 1 Jul 2020 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 May 2026 (estimated)
- First posted
- 14 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- Random assignment to one of the groups depending on the treatment options: 1. biofeedback and tibial neuromodulation 2. biofeedback and tibial neuromodulation + pelvic floor muscles training 3. biofeedback and tibial neuromodulation + pelvic floor muscles training + diet modification
| Arm | Type | Receives |
|---|---|---|
| biofeedback and tibial neuromodulation (BFB+TNM) | Experimental | Procedure: Biofeedback therapy, Procedure: Tibial neuromodulation |
| BFB+TNM + pelvic floor muscles training (PFMT) | Experimental | Procedure: Biofeedback therapy, Procedure: Tibial neuromodulation, Behavioral: Pelvic floor muscles training |
| BFB+TNM+PFMT+diet modification | Experimental | Procedure: Biofeedback therapy, Procedure: Tibial neuromodulation, Behavioral: Pelvic floor muscles training, Behavioral: Diet modification |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (8 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Biofeedback therapyAlso: BFBBiofeedback 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 | Procedure or surgery | BFB+TNM + pelvic floor muscles training (PFMT), BFB+TNM+PFMT+diet modification, biofeedback and tibial neuromodulation (BFB+TNM) |
| Tibial neuromodulationAlso: TNMTNM 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. | Procedure or surgery | BFB+TNM + pelvic floor muscles training (PFMT), BFB+TNM+PFMT+diet modification, biofeedback and tibial neuromodulation (BFB+TNM) |
| Pelvic floor muscles trainingAlso: PFMTPFMT 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. | Behavioural | BFB+TNM + pelvic floor muscles training (PFMT), BFB+TNM+PFMT+diet modification |
| Diet modificationAlso: DMDiet 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. | Behavioural | BFB+TNM+PFMT+diet modification |
Primary outcome
Mean stool frequency
Time frame: A week
clinical outcome
Mean stool form value
Time frame: A week
clinical outcome, assessed with the use of the Bristol stool scale (BSS)
Mean defecation with difficult bowel emptying
Time frame: a week
patient-reported outcome, clinical
Change of KESS scale points
Time frame: at the end-point, 6 months after enrolment
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
Time frame: at the end-point, 6 months after enrolment
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
Time frame: at the end-point, 6 months after enrolment
Values obtained during HR anorectal manometry
Maximum absolute anal squeeze pressure
Time frame: at the end-point, 6 months after enrolment
Values obtained during HR anorectal manometry
Average absolute anal squeeze pressure
Time frame: at the end-point, 6 months after enrolment
Values obtained during HR anorectal manometry
Average incremental anal squeeze pressure
Time frame: at the end-point, 6 months after enrolmentat the end-point, 6 months after enrolment
Values obtained during HR anorectal manometry
Residual push pressure
Time frame: at the end-point, 6 months after enrolment
Values obtained during HR anorectal manometry
Push relaxation percentage
Time frame: at the end-point, 6 months after enrolment
Values obtained during HR anorectal manometry
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2025.
- Individual participant dataSharing planned: Yes
Related trials for Pelvic Floor Prolapse
Recruiting
Safety and Performance of a Pelvic Floor Mesh Implant for Laparoscopic Sacrocolpopexy (ProGYNious)
Pelvic Organ Prolapse (POP), Synthetic Mesh
Recruiting
Pelvic Floor Muscle Training During Pregnancy
Urinary Incontinence, Anal Incontinence
Not yet recruiting
Perineal Protection Device for Reducing Perineal Trauma During Vaginal Delivery in First-time Mothers: a Multicenter Randomized Controlled Trial
Pelvic Floor Dysfunction, Perineal Laceration
RecruitingObservational study
Pelvic Floor Rehabilitation of Female Pelvic Floor Dysfunction
Pelvic Floor Disorders, Pelvic Organ Prolapse
Recruiting
Poly-L-Lactic Acid for Vulvovaginal Tissue Regeneration
Pelvic Organ Prolapse (POP), Cystocele
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Biofeedback therapy, Tibial neuromodulation and Pelvic floor muscles training in people with Pelvic Floor Prolapse and Functional Constipation, run by Federal State Budgetary Scientific Institution at 2 sites in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sergey Morozov, MD, PhD (+79104681801, morosoffsv@mail.ru), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean stool frequency (time frame: A week). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2025.