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Urological Science
J o u r n a l h o m e p a g e : w w w. e - u r o l - s c i . c o m

Original Article

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, 2Isfahan Kidney Disease Research Center, Isfahan University of Medical Sciences,
Isfahan, Iran, 3Department of Human Biology, University of Toronto, Toronto, ON, Canada

Abstract
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

Introduction *Address for correspondence: Dr. Farshad Gholipour,

Prostate cancer is one of the most common cancers in men, with Isfahan Kidney Disease Research Center, Isfahan University of Medical
a worldwide prevalence rate of 109.8 per 100,000 men.[1] As one Sciences, Isfahan, Iran.
E‑mail: farshad.gholipoor@gmail.com
of the standard therapeutic strategies for localized or selected

Submitted: 08‑Jan‑2022 Revised: 20‑Mar‑2022 Accepted: 05‑May‑2022 This is an open access journal, and articles are distributed under the terms of the Creative
Published: 16-Mar-2023 Commons Attribution‑NonCommercial‑ShareAlike 4.0 License, which allows others to
remix, tweak, and build upon the work non‑commercially, as long as appropriate credit
Access this article online is given and the new creations are licensed under the identical terms.
Quick Response Code: For reprints contact: WKHLRPMedknow_reprints@wolterskluwer.com
Website:
www.e‑urol‑sci.com
How to cite this article: Khorrami MH, Mohseni A, Gholipour F,
Alizadeh F, Zargham M, Izadpanahi MH, et al. Single session pre-operative
DOI: pelvic floor muscle training with biofeedback on urinary incontinence and
10.4103/UROS.UROS_12_22 quality of life after radical prostatectomy: A randomized controlled trial.
Urol Sci 2023;34:23-7.

© 2023 Urological Science | Published by Wolters Kluwer - Medknow 23

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Khorrami, et al.: Single session pelvic biofeedback training before radical prostatectomy
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.[5‑7] 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 Methods
This 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
24
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.
Results
In 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.
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Khorrami, et al.: Single session pelvic biofeedback training before radical prostatectomy

Figure 1: Patients’ enrollment diagram

Table 2 compares the ICIQ‑UI scores of the study groups

Table 1: Patient characteristics
at different time intervals after catheter removal. The mean
ICIQ‑UI score was significantly lower in the intervention Characteristics Control Intervention P
group at 1 and 3 months (P = 0.01 and P = 0.029, respectively) group group
(n=40) (n=40)
but similar at 6 months (P = 0.058). At 1, 3, and 6 months,
Preoperative
a similar pattern was observed in the number of continent
Age (range) 63.8 (50-74) 64.5 (58-73) NS
patients (ICIQ‑UI = 0) [Figure 2]. At 1, 3, and 6 months after
Body mass index, mean±SD 25.4±2.7 27.1±3.5 NS
catheter removal, 28 (70.0%), 23 (57.5%), and 19 (47.5%) Prostate weight (g), mean±SD 37.4±14.4 35.0±12.9 NS
patients in the intervention group had some degree of UI, while Preoperative LUTS (n) 13 15 NS
36 (90.0%), 33 (82.5%), and 22 (55.0%) patients in the control Previous TURP (n) 4 3 NS
group had some degree of UI. Two patients in the intervention Intraoperative
group and one patient in the control group had urge UI and Nerve‑sparing procedure (n)
were treated with anticholinergic; their urge UI was resolved Unilateral 14 12 NS
after 3 months. Table 3 compares the ICIQ‑LUTSqol scores Bilateral 10 13 NS
of the study groups. The intervention group had higher QoL Blood loss (mL), mean±SD 570±230 600±260 NS
scores after surgery at all time intervals (P < 0.05). Postoperative
Number of days with catheter, 18.1 (13-23) 19 (13-25) NS
mean (range)
Discussion Postoperative hormone therapy (n) 6 4 NS
Almost every patient who undergoes RP is at risk of UI. Postoperative radiotherapy (n) 6 6 NS
The main cause of UI in these patients is urethral sphincter Positive surgical margins (n) 4 3 NS
SD: Standard deviation, NS: Not significant, LUTS: Lower urinary tract
damage during surgery. Although sphincteric incontinence
symptoms, TURP: Transurethral resection of prostate
is the most common urodynamic finding in patients with
persistent UI after RP, other urodynamic findings such as these patients. UI may have a negative impact on a patient’s
detrusor instability, impaired detrusor contractility, bladder QoL[14] and, according to studies, may place a significant
outlet obstruction, or low urethral compliance may coexist.[11] socioeconomic burden on the health‑care system.[15] As a
According to epidemiologic studies, UI can occur in nearly result, postprostatectomy UI has received special attention
20% of patients and is strongly associated with decreased in recent studies. Efforts have been made to prevent and treat
QoL. Other studies have found that UI can be observed in UI, but it has been well established that UI following RP
44.4%–50% of patients[12,13] and that it is a serious problem in resolves in approximately 90% of patients within the 1st year

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Khorrami, et al.: Single session pelvic biofeedback training before radical prostatectomy
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
Intervention Control group
group (n=40) (n=40)
1 month 13.3 (4.5) 18.9 (5.0)
3 months 9.1 (3.6) 15.1 (4.6)
6 months 7.9 (3.7) 9.5 (3.8)
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
Intervention Control group
group (n=40) (n=40)
1 month 23.4 (8.0) 31.5 (8.6)
3 months 23.2 (9.3) 29.7 (10.5)
6 months 21.7 (8.5) 27.1 (10.0)
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
26
P
0.010
0.029
0.058
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
P
the management of stress UI. They stated that Kegel exercise
<0.001 is one of the effective methods for managing UI through the
0.005 mechanism of pelvic floor muscle exercise, but they also stated
0.011 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
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Khorrami, et al.: Single session pelvic biofeedback training before radical prostatectomy
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.
Conclusion
In 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.
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