Effectiveness of Standard vs. Biofeedback Electrical Stimulation- Enhanced Pelvic Floor Trining in Women with Mild Pelvic Organ Prolapse
- 1. Rehabilitation Medicine Department of Jingmen Central Hospital. No. 168 Xiangshan Avenue, Jingmen City, Hubei Province, China
- 2. Medical Ultrasound Laboratory, Department of Biomedical Engineering, College of Life Science and Technology, Advanced Bio-medical Imaging Facility, Huazhong University of Science and Technology. No. 1037 Luoyu Road, Hongshan District, Wuhan City, Hubei Province, China , Health Management center, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology. Wuhan, China
- 3. Medical Ultrasound Laboratory, Department of Biomedical Engineering, College of Life Science and Technology, Advanced Bio-medical Imaging Facility, Huazhong University of Science and Technology. No. 1037 Luoyu Road, Hongshan District, Wuhan City, Hubei Province, China
- 4. Health Management center, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology. Wuhan, China
- 5. Medical imaging technology, Wuhan University of Arts and Science. No.1 Shenghai Avenue, Wuhu Street, Huangpi District, Wuhan City, Hubei Province, China
- 6. Health Management center, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology. Wuhan, China
- 7. Obstetrics and Gynecology Department, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology. Wuhan, China. 1095 Jiefang Avenue, Qiaokou District, Wuhan City, Hubei Province, China
- 8. Healthcare Security ofice & Biomedical Engineering Lab, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology. Wuhan, China #These authors are equally contributing to the study
Abstract
Objective: This study aims to determine the efficacy of Pelvic Floor Muscle Training (PFMT) and lifestyle improvement versus combined biofeedback electrical stimulation-intensive PFMT in ordinary women with pelvic organ prolapse by detecting electrophysiological indicators of pelvic floor muscles.
Methods: A retrospective analysis was conducted on 437 women who visited our outpatient department for gynecological examinations due to conscious vaginal prolapse between May 2020 and September 2022. According to the Glazer protocol, general patient information was collected, and pelvic floor function was evaluated using pelvic floor surface electromyography.
Results: The experimental group showed significant differences in other evaluation values six months after the intervention (P < 0.05), except for mean amplitude variability in the rest pre-baseline stage (P = 0.067) and in the endurance contracts stage (P = 0.147). The control group showed significant improvements in all other indicators, except for the mean amplitude variability in the rest pre-baseline stage (P = 0.876). The average peak amplitude of phasic (flick) contractions and the average mean amplitude of tonic contractions in the experimental group improved significantly compared to those in the control group (P = 0.016 and 0.004, respectively).
Conclusion: Although PFMT can improve the condition of Pelvic Floor Muscles (PFMs), a combination of basic PFMT and biofeedback electrical stimulation therapy is more effective. Although the normal standard has not been achieved, the training duration of PFMs can be extended to achieve better results.
CITATION
Qin Z, Junchao Z, Mingyue D, Xiaoying J, Hongyi Z, et al. (2025) Effectiveness of Standard vs. Biofeedback Electrical Stimulation-Enhanced Pelvic Floor Trining in Women with Mild Pelvic Organ Prolapse. J Family Med Community Health 12(2): 1213.
KEYWODS
- Pelvic Floor Muscle Training
- Biofeedback Electrical Stimulation
- Pelvic Organ Prolapse
INTRODUCTION
Pelvic Organ Prolapse (POP) is a common problem in the field of female urology and reproduction. The reported prevalence of POP varies significantly among studies, ranging from 3% to 50% [1], and which is 9.6% in china [2]. More than 41% of women undergoing routine gynecological examinations have potential prolapse [3]. POP is caused by an imbalance of forces responsible for pelvic support, which keeps the uterus and other organs inside the pelvis [4]. Multiple factors can promote the development of POP, including vaginal delivery, constipation, obesity, menopause, chronic cough, and iatrogenic disorders [5]. Although most POP cases do not require treatment, vaginal prolapse extending beyond the vaginal opening can significantly influence women’s quality of life, including urinary, intestinal, or sexual dysfunction, which requires intervention. The available intervention measures include observation, lifestyle modifications like avoiding constipation and tension, Pelvic Floor Muscle Training (PFMT), cervical support, and surgery. Patients with asymptomatic prolapse can be observed; however, the gradual progression of POP over time is possible.
PFMT is effective in the early prevention and even treatment of POP and Pelvic Floor Dysfunction (PFD). The guidelines of the National Institute for Health and Care Excellence(NICE) point out that [6], a minimum of 16 weeks of supervised PFMT program should be considered as the first choice for symptomatic Pelvic Organ Prolapse Quantification System (POP-Q) stage I or II women. Behavioral intervention is a set of riskless, customizable therapies that help patients improve symptoms by changing their behavior or environment [7]. Electrical Stimulation (ES) can stimulate nerves and pelvic floor muscles (PFMs) by applying a mild electric current, an effective method to enhance PFM voluntary contractions and strengthen them [8]. NICE suggests [6] that electrical stimulation and/or biofeedback should be considered to help stimulate and adhere to treatment for women who cannot actively contract their PFMs. A study by ZHAO et al. found that after structured PFMT training including biofeedback electrical stimulation on women in POP I or II, there was a significant improvement in pelvic floor muscle condition [9]. To determine the efficacy of PFMT and biofeedback in healthy women with POP, this study retrospectively analyzed the effects of PFMT and lifestyle interventions, as well as the combined biofeedback therapy on women with mild symptoms of POP-Q less than stage II.
METHODS
Clinical Data
This retrospective observational study included 437 women who visited our outpatient department for gynecological examinations due to conscious vaginal prolapse between May 2020 and September 2022. All patients were evaluated according to the POP-Q System
[10] for POP and categorized as stage I or II. Patients were divided into two groups. The experimental group consisted of 239 individuals, with an average age of 59.97 ± 11.53 years, who received PFMT combined with pelvic floor manual therapy, lifestyle interventions and biofeedback electrical stimulation therapy. The control group consisted of 198 patients, with an average age of 60.67 ± 10.98 years, who received only PFMT, pelvic floor manual therapy and lifestyle interventions. General characteristics like age, BMI, and delivery time had no significant difference between the two groups (Table 1). After six months of guidance and training, all patients underwent pelvic floor Electromyography (EMG). All participants in the experiment verbally expressed informed consent and signed informed consent forms.
|
Experimental Group (n = 239) |
Control Group (n = 198) |
t |
P |
Age |
59.97 ± 11.527 |
60.61 ± 10.971 |
-.59 |
0.56 |
BMI |
22.29 ± 2.90 |
21.83 ± 2.83 |
1.69 |
0.09 |
Parity |
2.13 ± 1.42 |
2.06 ± 1.43 |
0.54 |
0.59 |
Childbirth Method |
0.45 ± 0.50 |
0.41 ± 0.49 |
0.90 |
0.37 |
Chronic Cough |
0.18 ± 0.39 |
0.15 ± 0.35 |
1.05 |
0.29 |
Constipation |
0.34 ± 0.47 |
0.27 ± 0.44 |
1.61 |
0.11 |
Table 1: Comparison of general characteristics between two groups.
The exclusion criteria were as follows: previous prolapse or incontinence surgery; women who received formal PFMT guidance during the last year; women who underwent hysterectomy; patients with symptoms obvious or above the POP-QII stage; severe vaginal or cervical erosion and infection; pregnant or postpartum women under six months. We use telemedicine and in- person visits every two weeks for follow-up to ensure data integrity and participant safety.
Experimental Methods
Control Group: PFM was performed independently by a professional physical therapist within six months, including rectus abdominis technique, pelvic technique, and pelvic floor technique. The techniques were adjusted according to the patient’s condition. Participants completed an average of 19 physical therapy sessions and were required to exercise 3–5 times a week for 15–30 min at home. Additionally, they received lifestyle recommendations like losing weight, avoiding constipation, quitting smoking, and avoiding weightlifting.
Experimental Group: Based on the control group, the PFMs were stimulated and contracted twice a week
[9] for 60 min using a bioelectric stimulation instrument (WEISI VTC-1). According to the Glazer protocol [11], the EMG signals of muscle responses were converted into Standardized Parameters by Surface Electromyography (sEMG), then recorded the results.
All methods were executed in accordance with the relevant guidelines and regulations. According to the individual’s condition, the current intensity ranges from 10 to 50 mA. Vaginal surface electrodes and abdominal surface electrodes are utilized for this purpose. During treatment, the participant is positioned in a supine position,vaginal electrodes are placed to contact both sides of the vaginal wall and are fully inserted into the vaginal canal. Abdominal surface electrodes are placed with one electrode two centimeters lateral to the umbilicus and the other two centimeters below the first one.
EMG signals are collected at specific time points: Typically, two sets of data are collected per time and the average is taken; before the first treatment and after the completion of 10 sessions of biofeedback treatment along with 5 sessions of pelvic floor manual therapy.
Pre-EMG Collection Assessment
Prior to collecting EMG data, a vaginal examination and palpation are conducted to ensure participants can correctly contract their pelvic floor muscles undergo an initial Glazer three-minute assessment to determine
pelvic floor muscle type. Then a Pelvic Organ Prolapse/ Quantification (POP-Q) assessment is performed to evaluate the degree of uterine prolapse, and then perform pelvic floor fascia manipulation treatment, including helping patients activate proprioception and correctly contract pelvic floor muscles. These assessments ensure that the EMG signals collected are accurate and free from interference.
Statistical Analysis
Perform data analysis using SPSS19.0. The general and intergroup test data of the subjects were compared by t-test, and the results were expressed as x? ± s. The count data were compared using the chi-square test and expressed in terms of rate. P < 0.05 was considered statistically significant.
RESULTS
Comparison of Pelvic Floor Muscle Function between the Two Groups Pre and Post- Intervention
During the initial diagnosis, Glazer was used to evaluate the Semg values of PFMs in both groups (Table 2).
|
Rest pre-baseline |
Phasic (flick) contractions |
Tonic contractions |
Endurance contractions |
Rest Post-baseline |
||||||
Average Mean Amplitude (uV) |
Mean Amplitude Variability (%) |
Average Peak Amplitude (uV) |
Time Before Peak (s) |
Time After Peak (s) |
Average Mean Amplitude (uV) |
Mean Amplitude Variability (%) |
Average Mean Amplitude (uV) |
Mean Amplitude Variability (%) |
Average Mean Amplitude (uV) |
Mean Amplitude Variability (%) |
|
Pre-Intervention |
|||||||||||
Experimental Group |
5.56 ± 7.01 |
0.40 ± 0.58 |
30.15 ± 16.72 |
0.72 ± 0.35 |
0.90 ± 0.55 |
18.81 ± 10.75 |
0.33 ± 0.14 |
14.93 ± 8.56 |
0.24 ± 0.13 |
4.10 ± 2.46 |
0.25 ± 0.29 |
Control Group |
7.16 ± 10.77 |
0.35 ± 0.44 |
28.31 ± 15.61 |
0.73 ± 0.35 |
0.95 ± 0.52 |
17.67 ± 9.56 |
0.35 ± 0.16 |
14.62 ± 8.84 |
0.25 ± 0.15 |
4.47 ± 3.40 |
0.25 ± 0.24 |
P |
0.072 |
0.364 |
0.240 |
0.776 |
0.372 |
0.247 |
0.075 |
0.708 |
0.336 |
0.193 |
0.927 |
Post-Intervention |
|||||||||||
Experimental Group |
3.43 ± 2.56 |
0.31 ± 0.39 |
36.07 ± 15.17 |
0.45 ± 0.26 |
0.58 ± 0.49 |
27.53 ± 12.64 |
0.23 ± 0.10 |
23.31 ± 10.56 |
0.22 ± 0.08 |
3.28 ± 2.63 |
0.38 ± 0.43 |
Control Group |
3.58 ± 2.68 |
0.36 ± 0.34 |
32.83 ± 12.75 |
0.49 ± 0.25 |
0.65 ± 0.42 |
24.44 ± 9.66 |
0.25 ± 0.10 |
22.44 ± 10.07 |
0.22 ± 0.08 |
3.51 ± 2.75 |
0.35 ± 0.37 |
t |
0.62 |
1.24 |
-2.39 |
1.66 |
1.58 |
-2.82 |
1.79 |
-0.87 |
0.30 |
1.34 |
-0.09 |
P |
0.536 |
0.215 |
0.016 |
0.097 |
0.115 |
0.004 |
0.074 |
0.382 |
0.766 |
0.381 |
0.435 |
Table 2: Comparison of each value of pelvic floor sEMG assessed using Glazer protocol before and after intervention.
There was no statistically significant difference in various indicators between the two groups (P > 0.05). After interverntion, the results revealed that the Average Peak Amplitude of Phasic (flick) contractions and the average mean amplitude of tonic contractions were significantly higher in the experimental group than in the control group, with statistically significant differences (P = 0.016 and 0.004, respectively).
Comparison of Pelvic Floor Electromyography Values in Both Groups after Six Months
Pelvic floor muscle function was assessed after PFMT, pelvic floor manual therapy and lifestyle intervention combined with biofeedback electrical stimulation for six months (Table 3).
|
Rest Pre-Baseline |
Phasic (Flick) Contractions |
Tonic Contractions |
Endurance Contractions |
Rest Post-Baseline |
||||||
Average Mean Amplitude (uV) |
Mean Amplitude Variability (%) |
Average Peak Amplitude (uV) |
Time Before Peak (s) |
Time After Peak (s) |
Average Mean Amplitude (uV) |
Mean Amplitude Variability (%) |
Average Mean Amplitude (uV) |
Mean Amplitude Variability (%) |
Average Mean Amplitude (uV) |
Mean Amplitude Variability (%) |
|
Experimental Group |
|||||||||||
T0 |
5.56 ± 7.01 |
0.40 ± 0.58 |
30.15 ± 16.72 |
0.72 ± 0.35 |
0.90 ± 0.55 |
18.81 ± 10.75 |
0.33 ± 0.14 |
14.93 ± 8.56 |
0.24 ± 0.13 |
4.10 ± 2.46 |
0.25 ± 0.29 |
T1 |
3.43 ± 2.56 |
0.31 ± 0.39 |
36.07 ± 15.17 |
0.45 ± 0.26 |
0.58 ± 0.49 |
27.53 ± 12.64 |
0.23 ± 0.10 |
23.31 ± 10.56 |
0.22 ± 0.08 |
3.28 ± 2.63 |
0.38 ± 0.43 |
t |
4.44 |
1.84 |
-3.86 |
9.23 |
6.61 |
-7.95 |
8.59 |
-9.51 |
1.46 |
-3.59 |
3.78 |
P |
0.000 |
0.067 |
0.000 |
0.000 |
0.000 |
0.000 |
0.000 |
0.000 |
0.147 |
0.000 |
0.000 |
Control Group |
|||||||||||
T0 |
7.16 ± 10.77 |
0.35 ± 0.44 |
28.31 ± 15.61 |
0.73 ± 0.35 |
0.95 ± 0.52 |
17.67 ± 9.56 |
0.35 ± 0.16 |
14.62 ± 8.84 |
2.244 ± 10.07 |
4.47 ± 3.40 |
0.25 ± 0.24 |
T1 |
3.58 ± 2.68 |
0.36 ± 0.34 |
32.83 ± 12.75 |
0.49 ± 0.25 |
0.65 ± 0.42 |
24.44 ± 9.66 |
0.25 ± 0.10 |
0.25 ± 0.15 |
0.22 ± 0.08 |
3.51 ± 2.75 |
0.35 ± 0.37 |
t |
4.53 |
-0.16 |
-3.09 |
7.31 |
6.08 |
-6.87 |
8.04 |
-7.99 |
2.17 |
-3.12 |
3.01 |
P |
0.000 |
0.000 |
0.002 |
0.000 |
0.000 |
0.000 |
0.000 |
0.000 |
0.032 |
0.002 |
0.003 |
Table 3: Comparison of each value of pelvic floor sEMG assessed using Glazer protocol after six months in each Group
Except for mean amplitude variability in the rest pre-baseline stage (P = 0.067) and mean amplitude variability in the endurance contracts stage (P = 0.147), there were significant differences in other evaluation values after intervention (P < 0.05). However, in control group, all indicators improved significantly (P < 0.05), except Mean Amplitude Variability in the rest pre-baseline stage (P = 0.876).
Comparison of Therapeutic Effects between Two Groups after Intervention
The two groups received intervention and guidance for follow-up visits after six months, and there was no significant difference in their perceived discomfort (P > 0.05) (Table 4).
|
Recovered |
Improved |
Invalidated |
Experimental group |
65 (27.2) |
99 (41.4) |
75 (31.4) |
Control group |
42 (21.2) |
76 (38.4) |
80 (40.4) |
χ2 |
|
4.319 |
|
P |
|
0.115 |
|
Table 4: Comparison of symptom improvement between the two groups after six months
DISCUSSION
POP symptoms exhibit an age-dependent pattern, with approximately 6% of females aged 20-29, 31% of females
aged 50-59, and 50% of females aged 80 or above [12]. Bø K, et al. [13] reviewed high-level evidence from 11 randomized controlled trials and discovered that PFMT is the frontline treatment for POP in the general female population. It has a dose-response relationship with POP staging and can effectively reduce POP symptoms and improve POP staging (one stage) in POP-Q stage I, II, and III women. Another systematic review [14] revealed that there is sufficient evidence to prove the efficacy of PFMT in improving pelvic floor muscle contraction.
PFMT can systematically contract the elevator any muscle and improve pelvic function. It can also improve symptoms related to stress or mixed urinary incontinence[15] and may slightly improve symptoms in women with mild prolapse. The adverse effects of PFMT on POP women are almost non-existent, and if present, they are mostly unrelated to PFMT. Despite the lack of long-term follow-up studies, existing clinical trials and expert consensus have acknowledged the application of PFMT [16]. However, also
have research indicates that PFMT cannot reverse or treat POP [17].
The ability to accurately contract these muscles is crucial for effective PFMT. Biofeedback-assisted PFMT is the most widely used PFMT monitoring method. Biofeedback can be used to teach women how to contract the correct muscles, when and how to contract muscles to prevent leakage, and how to measure whether muscle contraction improves over time [18-20]. Therefore, the effects of biofeedback combined with electrical stimulation on POP treatment were investigated in this study. Despite significant improvements in the electromyographic values of the phasic (flick), tonic, and endurance contractions tests for the experimental and control groups after six months of PFMT, these values failed to reach the normal standard, indicating pelvic floor muscle abnormalities, which are associated with symptoms including stress urinary incontinence, pelvic organ prolapse, defecation dysfunction, sexual frigidity, and decreased sexual experience. However, the experimental group demonstrated a more significant improvement in various values compared to the control group. Notably, the EMG values of the average peak amplitude of phasic (flick) contractions and the average mean amplitude of tonic contractions improved significantly in the experimental group compared to the control group, with statistically significant differences.
These results indicate that combining basic PFMT and biofeedback electrical stimulation therapy is more effective than simple PFMT. Multiple studies [21-23] have recently confirmed the effectiveness of electrical stimulation with or without biofeedback in treating pelvic floor dysfunction. The beneficiaries include patients with postpartum pelvic floor dysfunction, postpartum urinary incontinence, and pelvic floor muscle contraction deficiency. However, the current research primarily focuses on women with postpartum pelvic floor dysfunction, urinary incontinence, or POP-II or above. This study focused on women with mild symptoms and POP-II or below and investigated the effectiveness of electrical stimulation in improving pelvic floor muscle contraction function in ordinary women. This study can serve as a guide for treating patients with mild POP. Hagen, et al. [24] conducted a two-year multicenter randomized controlled trial to analyze and compare the clinical effectiveness of simple and biofeedback-mediated PFMT. The results revealed no significant difference between the two; however, the study did not include electrical stimulation therapy and indirectly reflected the advantages of electrical stimulation.
This study has several limitations. First, as a single-center retrospective study, it lacks randomization and blinded assessment, which may lead to selection bias and information bias. Moreover, relying on past medical records means that the data may be incomplete or inaccurate. Second, when using electromyography to measure pelvic floor muscle function, it is affected by factors such as electrode placement, skin preparation, and the patient’s muscle contraction ability. It only reflects muscle electrical activity and cannot fully reflect muscle strength, endurance, and coordination. Third the intervention measures in this study are limited to cases below POP-II, and there is insufficient understanding of the characteristics of the participants. Therefore, when generalizing these findings to women with POP who need surgical treatment, caution should be exercised. Future studies should record the characteristics of participants in detail to accurately assess the therapeutic effect and make reasonable extrapolations. In the home exercise program, patients are responsible for their own treatment. This may be a positive factor. A biofeedback electrical stimulation program combined with health education can more effectively improve the psychological state of patients (such as anxiety and depression) and enhance treatment compliance. Therapists should encourage and closely monitor patients to prevent them from dropping out.
In the future, high-quality prospective randomized controlled trials should be conducted, using standardized stimulation parameters such as current intensity, frequency, and pulse width. Detailed records and analyses of participant characteristics should be made to verify and optimize the treatment methods and improve the quality of life of women with mild POP.
CONCLUSION
This study validated the effectiveness of basic PFMT on PFMs and demonstrated that combining biofeedback and electrical stimulation can improve the results. However, in the absence of a structured follow-up plan or encouragement for further training after the initial supervision of PFMT, performing PFMT alone may be challenging and difficult to maintain in the long term for some women, especially for older age groups. Therefore, their families and medical staff need to constantly encourage and actively seek strategies to improve compliance, promoting early recovery of PFMs.
DECLARATIONS
Ethics Approval and Consent to Participate
The institutional review board of Obstetrics and Gynecology Hospital Medical College, Zhejiang University Ethics Committee approved all procedures.
Availability of Data and Materials
The datasets generated during and/or analysed during the current study are available from the corresponding author on reasonable request.
Competing Interests
The authors declare that they have no competing interests.
Funding
This study was supported by Natural Science Foundation of Hubei Province (2025AFC103), Key Science and Technology Program of Jingmen (2024YFYB135).
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