Relapse prophylaxis and early recognition of pelvic organ prolapse in primary medical care organizations
| ISRCTN | ISRCTN23741622 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN23741622 |
- Submission date
- 17/01/2023
- Registration date
- 30/01/2023
- Last edited
- 14/03/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nervous System Diseases
Plain English summary of protocol
Background and study aims
It is necessary to develop a tactic for pelvic floor rehabilitation, given the high frequency of operations for genital prolapse in women, the frequency of relapses and the lack of clear recommendations for postoperative management. This study will research a course of pelvic floor muscle training after pelvic prolapse surgery with the aim of improving pelvic floor muscle contraction strength, and preventing the recurrence of pelvic prolapse. The strength of muscle contractions of the pelvic floor muscles may serve as a prognostic identifier for a possible recurrence of pelvic prolapse.
Who can participate?
Patients with grade II anterior and posterior vaginal wall prolapse and grade III stress urinary incontinence
What does the study involve?
Patients in both groups will receive surgical treatment. In the treatment group, 2 months after the operation, the patients will undergo a 6-month course of training for the pelvic floor to assess the effect of such a scheme on the strength of muscle contractions and determine the threshold value of muscle strength for predicting relapse in primary medical care organizations.
What are the possible benefits and risks of participating?
Operative treatment carries the risks of complications, however, it is carried out in accordance with the protocol for the diagnosis and treatment of genital prolapse of the Republic of Kazakhstan, and the operating doctor is responsible for the complications of surgical treatment on the basis of the contract. Surgical treatment is not a new method or our development. Our suggestion to do the exercises for 6 months would probably cause pelvic pain or discomfort. However, to avoid risks, we started the exercises 2 months after the operation, when we found complete healing of the vaginal tissue. There were no unwanted effects. The scheme of exercises was not exhausting and was simple to follow.
Where is the study run from?
Kazakhstan Medical University (Kazakhstan)
When is the study starting and how long is it expected to run for?
February 2021 to July 2022
Who is funding the study?
Kazakhstan Medical University (Kazakhstan)
Who is the main contact?
Dr Mariya Laktionova, mariya070692@gmail.com
Contact information
Principal Investigator
Chief Researcher
Kazakhstan’s Medical University
Kazakhstan School of Public Health
Otepov street 19a
Almaty
050060
Kazakhstan
 ORCID ID |
0000-0002-9435-8841 |
|---|---|
| Phone | +7 87057580232 |
| rigel1992@mail.ru |
Scientific
Kazakhstan’s Medical University
Kazakhstan School of Public Health
Otepov street 19a
Almaty
050060
Kazakhstan
| Phone | None provided |
|---|---|
| mkkutzhan@gmail.com |
Scientific
Caspian International School of Medicine
Caspian University
Dostyk 85 A avenue
Almaty
050000
Kazakhstan
| ORCID ID |
0000-0002-9056-2394 |
|---|---|
| Phone | None provided |
| altyn.aringazina@gmail.com |
Scientific
Kyrgyz-Russian Slavic University
st. Kievskaya, 44
Bishkek
720000
Kyrgyzstan
| Phone | None provided |
|---|---|
| askerov.arsen@inbox.ru |
Scientific
Public health and social sciences department
Kazakhstan’s Medical University
Otepov street 19a
Almaty
050060
Kazakhstan
| ORCID ID |
0000-0003-0219-7874 |
|---|---|
| Phone | None provided |
| mairash@list.ru |
Public
Kazakhstan’s Medical University
Otepov street 19a
Almaty
050060
Kazakhstan
| Phone | +7 701 402 9691 |
|---|---|
| Ingling-freia@mail.ru |
Public
Kazakhstan’s Medical University
Kazakhstan School of Public Health
Otepov street 19a
Almaty
050060
Kazakhstan
| ORCID ID |
0000-0003-2261-4428 |
|---|---|
| Phone | None provided |
| imasheva_bayan@inbox.ru |
Study information
| Study design | Randomized controlled single-blind study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Home |
| Study type | Prevention |
| Participant information sheet | Not available in web format, please use the contact details to request a participant information sheet |
| Scientific title | Optimization of the surgical treatment of genital prolapse |
| Study acronym | POPRP |
| Study objectives | 1. Pelvic floor muscle training after pelvic prolapse surgery improves pelvic floor muscle contraction strength 2. Pelvic floor muscle training after surgical treatment after pelvic prolapse surgery serves to prevent the recurrence of pelvic prolapse 3. The strength of muscle contractions of the pelvic floor muscles serves as a prognostic identifier for a possible recurrence of pelvic prolapse |
| Ethics approval(s) | Approved 28/01/2021: Bioethics committee of the Kazakhstan Medical University "Higher School of Public Health" (19A Utepov street, Аlmaty, Republic of Kazakhstan, +7(727) 337 80 28; ksph@ksph.kz), ref: 132/4 |
| Health condition(s) or problem(s) studied | Prevention of recurrence of genital prolapse after surgical treatment |
| Intervention | The study aims to prevent the recurrence of genital prolapse after surgical treatment (anterior and posterior colpotomy, colporrhaphy with perineal levatorplasty) using a combination of a 6-month course of training for the pelvic floor muscles. The authors will randomly divide the participants into two groups. Each participant receives an envelope with the number of the group they would be assigned to. The chief investigator knows which group patients are assigned to, whereas the participants are blinded to which group they were assigned to. Participants were divided into 2 groups: the treatment group (30 patients) and the control group (30 patients). The participants will complete a study program and a follow-up examination. Compliance is continuously controlled by gynaecologists in an online regimen. Exercises are expected to be comfortable to perform during the everyday routine and not be exhausting. Procedure The patients in both groups underwent surgical treatment such as anterior and posterior colpotomy, colporrhaphy with perineal levatorplasty. These surgical methods are included in Kazakhstan's clinical protocol for the diagnosis and treatment of female genital prolapse. The patients in the treatment group started the pelvic floor muscle training program 2 months after surgery and continued the program for 6 months. The patients in the control group followed conventional recommendations for 2 months (6-8 weeks) - the required amount of time when the sutures (Vikryl) dissolve completely, pelvic pain disappears and the patients feel completely normal. Physical activity is not recommended until complete healing (6-8 weeks), as it may cause pain or interfere with the healing process. Before training, all patients will be given instructions on the structure of pelvic floor muscles, their function, the importance of training and training techniques, as well as which muscles we work on during training. All patients will be trained in how to perform pelvic floor exercises during their visit to the gynecologist. Training program: First week: 3 rounds of 10 contractions of the pelvic floor muscles (hold 3 seconds) and 3 rounds of 5 contractions (hold 12 seconds) per session, twice a day every other day; from the second week to the 12th week: 3 rounds of 20 contractions of the pelvic floor muscles (hold for 3 seconds) and 3 rounds of 10 contractions (hold for 12 seconds) per session, twice a day every other day; from weeks 13 to 24: 3 rounds of 20 contractions of the pelvic floor muscles (hold for 3 seconds) and 3 rounds of 10 contractions (hold for 12 seconds) per session, twice a day every day. All patients were divided between 6 gynaecologists in primary medical care organizations who controlled the compliance of patients to prescribed recommendations and training with an online monitoring system using available messengers. |
| Intervention type | Mixed |
| Primary outcome measure | Presence of anatomical prolapse measured during gynecological examination using POP-Q international scale for the estimation of prolapse stage prior to treatment and 8 months after surgical operation |
| Secondary outcome measures | Helath-related quality of life measured using the Prolapse Quality of Life Questionnaire (P-QoL) in Russian and Kazakh languages prior to treatment and 8 months after treatment. |
| Overall study start date | 01/02/2021 |
| Completion date | 31/07/2022 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target number of participants | 60 |
| Total final enrolment | 60 |
| Key inclusion criteria | 1. Anterior and posterior vaginal wall prolapse stage II, according to the Pelvic Organ Prolapse Quantification System (POP-Q) classification and stress-induced urinary incontinence stage III, which was determined by the classification of D.V. Kahn 2. Aged 45 years old and under 3. History of two or more labours 4. No consent for conservative treatment 5. No consent for use of vaginal synthetic prostheses, including urethral sling 6. No history of conservative treatment of prolapse, including pelvic floor muscles training 7. No history of metabolic diseases (diabetes mellitus, obesity, metabolic syndrome, thyroid gland disorders, calcium phosphate metabolism disorders) |
| Key exclusion criteria | 1. Urgent or combined urinary incontinence 2. Contraindications to surgical treatment and anaesthesia (general and regional anaesthesia: spinal, epidural anaesthesia) 3. Acute or chronic inflammatory diseases, acute phase of infectious diseases, malignant tumours, anaemia, benign ovarian and/or uterine tumours, pregnancy, haemorrhoids stage 3 and 4, decompensated chronic diseases, thrombosis and multiple drug allergies |
| Date of first enrolment | 01/08/2021 |
| Date of final enrolment | 01/10/2021 |
Locations
Countries of recruitment
- Kazakhstan
Study participating centre
Almaty
50060
Kazakhstan
Sponsor information
University/education
C/o: Ryskulova Alma-Gul
Head of the Department of Public Health
Almaty
50060
Kazakhstan
| Phone | +7 701 526 2869 |
|---|---|
| r.alma@bk.ru | |
| Website | http://www.ksph.kz/?lang=en |
"ROR" |
https://ror.org/034p3rp25 |
Funders
Funder type
University/education
No information available
Results and Publications
| Intention to publish date | 01/03/2022 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not expected to be made available |
| Publication and dissemination plan | Planned publication in a high-impact and peer-reviewed journal. |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are not expected to be made available due to a lack of participant consent to share data. All data will be in a non-public Excel database, strictly anonymously. All the participants signed the informed consent prior to be enrolled in a study. This complies with the requirements for clinical trials, which are conducted at the initiative of the author. Registration of the study is carried out in the research base of the university on behalf of which the study is being conducted. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol file | 30/01/2023 | No | No |
Additional files
Editorial Notes
14/03/2023: A public contact was amended.
24/01/2023: Trial's existence confirmed by the bioethics committee of the Kazakhstan Medical University "Higher School of Public Health".
