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ORIGINAL ARTICLE
Year : 2023 | Volume
: 34
| Issue : 1 | Page : 23-27
Single session pre-operative pelvic floor muscle training with biofeedback on urinary incontinence and quality of life after radical prostatectomy: A randomized controlled trial
Mohammad-Hatef Khorrami1, Amir Mohseni1, Farshad Gholipour2, Farshid Alizadeh1, Mahtab Zargham1, Mohammad-Hossein Izadpanahi1, Mehrdad Mohammadi Sichani1, Farbod Khorrami3
1 Department of Urology, Isfahan University of Medical Sciences, Isfahan, Iran
2 Isfahan Kidney Disease Research Center, Isfahan University of Medical Sciences, Isfahan, Iran
3 Department of Human Biology, University of Toronto, Toronto, ON, Canada
Correspondence Address:
Farshad Gholipour
Isfahan Kidney Disease Research Center, Isfahan University of Medical Sciences, Isfahan
Iran
Source of Support: None, Conflict of Interest: None
DOI: 10.4103/UROS.UROS_12_22
Purpose: Urinary incontinence (UI) is a common complication of radical prostatectomy (RP) affecting patient's quality of life (QoL). In the present study, we aimed to investigate the effects of single-session preoperative pelvic floor muscle training (PFMT) with biofeedback (BFB) on short- and mid-term postoperative UI and QoL. Materials and Methods: This study was performed between 2018 and 2020. The patients were randomized into two groups: the case group received a training session with BFB, supervised oral and written instructions on pelvic floor muscle exercises in a 1-h-long training session 1 month before the surgery. Patients were asked to regularly perform exercises immediately after the session until surgery. The controls received no instructions. We used the International Consultation on Incontinence Questionnaire-UI (ICIQ-UI) short-form and ICIQ-Lower Urinary Tract Symptoms QoL Module (ICIQ-LUTSqol) at 1, 3, and 6 months after removing the urinary catheter. Results: A total of 80 patients with a mean age of 63.83 ± 3.61 years were analyzed. Patient characteristics were similar between the groups. The mean ICIQ-UI score was significantly lower in the intervention group at 1 and 3 months after catheter removal (P = 0.01 and P = 0.029, respectively) but similar at 6 months (P = 0.058). The mean ICIQ-LUTSqol score was significantly lower in the intervention group at 1, 3, and 6 months after catheter removal (P < 0.001, P = 0.005, and P = 0.011, respectively). Conclusion: A single session of preoperative PFMT with BFB has significant short-term effects on UI after RP but not at 6 months. However, this intervention can improve LUTS-related QoL even at 6 months after catheter removal.
Keywords: Physical therapy modalities, prostatectomy, prostatic neoplasms, quality of life, urinary incontinence
Prostate cancer is one of the most common cancers in men, with a worldwide prevalence rate of 109.8 per 100,000 men.[1] As one of the standard therapeutic strategies for localized or selected locally advanced prostate cancer, radical prostatectomy (RP) is associated with a number of complications, including bleeding, urinary tract infection, urinary incontinence (UI), and erectile dysfunction.[2] Postoperative UI, which has been reported in up to 40% of patients, is one of the most serious complications that can significantly reduce the quality of life (QoL) of patients undergoing RP.[3] Because most cases of UI are improved within 1 year of RP, invasive treatments such as bulking agent injections, male slings, or artificial sphincter placement are usually initiated after 1 year of follow-up.[4]
One of the noninvasive treatment methods for UI is pelvic floor muscle training (PFMT) with biofeedback (BFB).[4] Previous studies have found contradictory results for the role of PFMT in reducing UI after RP. The majority of the studies that found no significant effect used PFMT during the postoperative period.[5],[6],[7] These controversial results could be attributed to two major issues: first, the effects of PFMT typically begin within 6–8 weeks of treatment; second, UI in some patients may resolve spontaneously within the 1st week after RP. Therefore, the likelihood of finding significant results is reduced, which may lead to inconsistent results regarding the role of PFMT with BFB.[8] Furthermore, few studies have investigated lower urinary tract symptom (LUTS)-related QoL in these patients.
The combination of PFMT and BFB is a novel research topic in the field of RP. The purpose of this study was to investigate the effects of single-session preoperative PFMT with BFB on UI and QoL in patients undergoing RP in the short- to mid-term after the surgery, when UI is more prevalent.
Materials and MethodsThis randomized controlled clinical trial was conducted in a tertiary university hospital from 2018 to 2020. The study protocol was approved by the Institutional Review Board of Isfahan University of Medical Sciences (IR.MUI.REC.396.926, 2017-06-03) and was registered at https://irct.ir/ (IRCT20170716035104N3). All patients provided informed consent to participate in the study.
Men aged 50–75 years old with localized or locally advanced prostate cancer who were candidates for RP were included in the study. Uncontrolled diabetes mellitus, previous neurologic diseases, UI prior to surgery, neurogenic bladder, and irregular follow-up visits were all exclusion criteria.
Age, weight, height, prostate volume, presence of LUTS, and history of previous transurethral resection of prostate (TURP) were all collected as baseline characteristics. Preoperative LUTS is defined as any storage or voiding symptoms that occur at least half of the time. Using Random Allocation Software v1.0, the patients were randomly assigned to one of the two groups. In the case group, patients were visited by an experienced physiotherapist who instructed them on PFMT using BFB techniques in a 1-hour training session, so they learned how to exercise at home for 1 month prior to surgery. Further, patients were given toilet training instructions as well as a standardized BFB-guided exercise protocol that included maximum voluntary contractions, endurance, relaxation, and coordination with abdominal breathing. Surface electrodes were used to evaluate muscle strength and contractions lasting 5–10 s, with 10–15 repetitions.
Patients in the case group were given a home exercise program and told to begin exercising right away. These patients did the exercises twice a day at home, for half an hour each time. Patients were given a checklist to track the frequency with which they performed the exercises, and patients who performed the prescribed exercises <70% of the scheduled time were excluded from the study. Before the surgery, the control group received no PFMT instructions.
Then, both groups of patients underwent open retropubic RP by a single surgeon with over 500 radical prostatectomies under his belt. The nerve-sparing technique was used whenever possible. In both the groups, all patients with UI at 6 months after catheter removal received PFMT with BFB. We evaluated the patients at 1, 3, and 6 months after the urinary catheter was removed. We collected data on UI and LUTS-related QoL using the International Consultation on Incontinence Questionnaire UI Module (ICIQ-UI short form) and the ICIQ-LUTSqoL Module. The reliabilities of the Persian language versions of these questionnaires were assessed by Hajebrahimi et al. and Pourmomeny et al., respectively.[9],[10] Lower scores in both the questionnaires indicate a better state of UI and QoL.
IBM SPSS Statistics version 24.0 (IBM SPSS Statistics for Windows, Version 24.0. Armonk, NY: IBM Corp) was used to analyze the study data. To demonstrate data, we used the mean and standard deviation (SD) in the form of figures and tables. Moreover, the independent t-test was used to analyze quantitative data. The level of significance was set at P < 0.05.
ResultsIn this study, 90 patients were enrolled and randomly assigned to one of the two groups. Following the surgical procedures, ten patients (five in each group) were excluded due to loss of follow-up (n = 3), discontinuation of intervention (n = 3), and irregular postoperative visits (n = 4). In the end, data of 80 men were analyzed. [Figure 1] depicts the CONSORT flow diagram for patients.
The age ranged from 50 to 74 years (mean ± SD: 63.83 ± 3.61) in the control group, while the age ranged from 58 to 73 years (mean ± SD: 64.55 ± 6.31) in the intervention group. There was no statistically significant difference in age (P = 0.53) between the two groups. [Table 1] compares patient characteristics between the study groups. There was no significant difference in body mass index, prostate weight, the presence of preoperative LUTS, previous TURP, nerve-sparing procedure, intraoperative blood loss, days with the catheter, postoperative hormone therapy, postoperative radiotherapy, or surgical margin status. Adjuvant radiotherapy did not begin until 6 months after the surgery.
[Table 2] compares the ICIQ-UI scores of the study groups at different time intervals after catheter removal. The mean ICIQ-UI score was significantly lower in the intervention group at 1 and 3 months (P = 0.01 and P = 0.029, respectively) but similar at 6 months (P = 0.058). At 1, 3, and 6 months, a similar pattern was observed in the number of continent patients (ICIQ-UI = 0) [Figure 2]. At 1, 3, and 6 months after catheter removal, 28 (70.0%), 23 (57.5%), and 19 (47.5%) patients in the intervention group had some degree of UI, while 36 (90.0%), 33 (82.5%), and 22 (55.0%) patients in the control group had some degree of UI. Two patients in the intervention group and one patient in the control group had urge UI and were treated with anticholinergic; their urge UI was resolved after 3 months. [Table 3] compares the ICIQ-LUTSqol scores of the study groups. The intervention group had higher QoL scores after surgery at all time intervals (P < 0.05).
Figure 2: Comparison of continent patients (ICIQ-UI = 0) in the two groups at 1, 3, and 6 months after catheter removal. ICIQ-UI: International Consultation on Incontinence Questionnaire-Urinary Incontinence
Table 2: Comparison of mean (standard deviation) International Consultation on Incontinence Questionnaire - Urinary Incontinence score in the intervention and control groups at 1, 3, and 6 months after catheter removal
Table 3: Comparison of mean (standard deviation) International Consultation on Incontinence Questionnaire Lower Urinary Tract Symptoms Quality of Life score in the intervention and control groups at 1, 3, and 6 months after catheter removal Discussion Almost every patient who undergoes RP is at risk of UI. The main cause of UI in these patients is urethral sphincter damage during surgery. Although sphincteric incontinence is the most common urodynamic finding in patients with persistent UI after RP, other urodynamic findings such as detrusor instability, impaired detrusor contractility, bladder outlet obstruction, or low urethral compliance may coexist.[11] According to epidemiologic studies, UI can occur in nearly 20% of patients and is strongly associated with decreased QoL. Other studies have found that UI can be observed in 44.4%–50% of patients[12],[13] and that it is a serious problem in these patients. UI may have a negative impact on a patient's QoL[14] and, according to studies, may place a significant socioeconomic burden on the health-care system.[15] As a result, postprostatectomy UI has received special attention in recent studies. Efforts have been made to prevent and treat UI, but it has been well established that UI following RP resolves in approximately 90% of patients within the 1st year of RP. A faster recovery of UI appears to be associated with a higher QoL.
Pelvic floor exercises, supportive care, medications, neuromuscular electrical stimulation, surgery, bulking agent injections, and devices such as artificial sphincter and bulbourethral sling are some of the treatments available for UI after RP. The majority of these therapeutic strategies are invasive and not carried out within the first 1 year of the surgery.[16] One of the treatment strategies that could be initiated preoperatively is PFMT with BFB.[17]
BFB is regarded as an important mind–body technique involving the control of involuntary bodily functions. With the use of BFB training, patients may be able to improve their body functions. During a BFB session, a therapist instructs patients on how to perform specific muscle improvement exercises. BFB exercises for the pelvic floor muscles could be designed to improve muscle strength, support the urinary tract, prevent urinary leakage, and improve urgency.
In 2015, Ong et al.[18] conducted a study on 40 patients in Malaysia and evaluated the effectiveness of BFB Kegel exercise on stress UI. This study found that after 16 weeks of BFB Kegel exercise, pelvic muscle strength and UI score improved significantly, implying that these exercises should be considered as effective therapeutic methods. Furthermore, Vickers and Davila[19] conducted another study on the use of Kegel exercises and BFB in women with UI. They stated that these pieces of training are almost unbearable for patients, but they are also associated with significant improvements in UI in these patients.In 2014, Park and Kang[20] conducted a review of previous clinical trials to assess the effect of Kegel exercises on the management of stress UI. They stated that Kegel exercise is one of the effective methods for managing UI through the mechanism of pelvic floor muscle exercise, but they also stated that more research should be conducted on this topic.
There is also some evidence of the effects of Kegel exercises on UI after RP. As demonstrated by Aydın Sayılan and Özbaş,[21] Kegel exercise and PFMT after RP could alleviate UI between the 3rd and 6th months after the surgeries. Another study, conducted by Pan et al.,[22] found that pelvic muscle training after RP may help reduce UI, but it also stated that some patients may not benefit from this training, and as a result, their QoL may not improve. Other studies have suggested that advanced pelvic floor muscle exercise may be an appropriate therapeutic option after RP, but not all patients benefit from this training until 1 year after prostatectomy.[23] Previous studies claimed that BFB exercises after RP may not be beneficial in all patients and that other strategies should be developed for the best therapeutic results.
Another study published in 2013 by Dijkstra-Eshuis et al.[24] assessed the effects of BFB on UI after RP and concluded that these treatments do not appear to be effective in preventing UI and improving the QoL of patients. Kannan et al.[25] discovered that BFB and pelvic floor muscle exercises have no significant effect on the prevalence of UI following RP. Previous research on this topic has also yielded contradictory results.[26]
We believe that these controversies existed in previous research because UI after RP could resolve without treatments within months of the surgeries,[27],[28] and PFMT takes time for their effects to appear in patients and requires high patient compliance.[29] These issues complicate the evaluations of PFMT effects. To address the aforementioned problems, we designed this study to evaluate the true effects of PFMT with BFB on UI by starting the training almost 1 month before the operation. Because of this design, the effects of PFMT with BFB were observed immediately after surgery, and patients in the intervention group had a lower incidence of UI and better QoL. It should be noted that this training has no effect on anatomical disorders of the urinary sphincter, but it does influence the functional disorders of patients.
Despite previous surveys, we used PFMT with BFB 1 month before RP in the current study and observed significant improvements in UI and QoL of patients 3 months after the surgeries. After 6 months, there were no significant differences in UI among patients between the intervention and control groups, but the intervention group had higher QoL scores. These findings highlight the impact of preoperative PFMT with BFB on UI and QoL of patients in the first 3 months after the surgeries. We recommend that surgeons consider the beneficial effects of pelvic muscle exercises prior to RP. We believe that these pieces of training are appropriate to perform and cost-effective and that they should be recommended for all patients.
ConclusionIn summary, we demonstrated that even a single-session of PFMT with BFB has beneficial effects on UI in the short-term after surgery and is effective in improving LUTS-related QoL in the long term. We believe that these short- and mid-term effects have high clinical value and that more emphasis should be placed on the use of preoperative PFMT with BFB in patients undergoing RP.
Financial support and sponsorship
Nil.
Conflicts of interest
There are no conflicts of interest.
References
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