The nursing application of multifunctional protective pants after posterior urethral stricture surgery: A randomized clinical trial

doi:10.21203/rs.3.rs-3437887/v1

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The nursing application of multifunctional protective pants after posterior urethral stricture surgery: A randomized clinical trial

https://doi.org/10.21203/rs.3.rs-3437887/v1

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Objective

Posterior urethral stricture is a severe disease in urology, and end-to-end urethral anastomosis remains the gold standard treatment. The surgical outcome not only depends on meticulous intraoperative management but also on postoperative care. Key aspects of postoperative care include stable compression bandaging, prevention of skin tension and allergic blistering, and preventing penile from erection. We have produced a multifunctional protective pant that is expected to prove its effectiveness through a randomized controlled study.

Methods

This study included 50 patients who were divided into an experimental group and a control group. The patients in the experimental group wore the protective pants immediately after surgery. On the basis of routine care in the control group, health education and guidance for patients and family members on wearing protective pants were added. During the postoperative period until discharge, we observed the occurrence of wound bleeding, abnormal body temperature, and evaluated patient infection status based on results such as blood routine and procalcitonin. A numerical scoring table was used for pain assessment during the three days and nine shifts handover of patients. Patient feedback during pants usage was obtained through a self-assessment questionnaire two months after surgery.

Results

On the second day after surgery, the incidence of penile hematoma in the experimental group was significantly lower than that in the control group, with a statistically significant difference (P < 0.05). Within five days after surgery, the experimental group had a significantly lower incidence of wound bleeding, Scrotum edema, Skin allergic blisters and erectile pain compared to the control group, with a statistically significant difference (P < 0.05).

Conclusion

The use of the protective pants effectively reduced postoperative complications during the perioperative period, and significantly improving surgical success rates and patient satisfaction.

Urethral stricture

Fixed pants

Complications

Nurse

Posterior urethral strictures are complex urological conditions that occur after urethral injury from pelvic fractures^[1–3]. For patients with posterior urethral strictures, end-to-end urethral anastomosis remains the gold standard procedure with the best outcome^{[4, 5]}. The success of the procedure depends not only on the delicate intra-operative management, but also on the postoperative care^{[6, 7]}. There are various issues related to the care of patients after posterior urethral end-to-end anastomosis. Firstly, the immediate postoperative dressing often involves the use of gauze combined with adhesive tape crossed with pressure, which often leads to allergic blisters and tension blisters on the patient's skin after surgery, causing unnecessary skin damage. Secondly, the fixation of adhesive tape is not firm, and the tape often becomes loose when patients engage in active movement, which fails to achieve the effect of pressure bandaging and increases the risk of postoperative wound bleeding. In addition, patients need to inhibit erection to reduce cavernous bleeding after surgery, and estrogenic drugs have been used in the past, but they are ineffective and could lead to endocrine disorders in male patients.

In order to reduce the occurrence of complications in patients with urethral strictures after surgery and improve their quality of life, our department has independently developed multifunctional protective pants. These pants facilitate the daily life management and home care of patients after urethral stricture surgery, targeting three key aspects of postoperative care for urethral stenosis, and are expected to reduce the occurrence of postoperative complications.

The application of multifunctional protective pants in patients after posterior urethral stricture surgery has facilitated the observation of wound conditions, provided pressure dressing and catheter fixation, reduced the risk of catheter slippage, and at the same time avoided unnecessary traction and patient discomfort. The design of the perineal ice pack helps suppress abnormal erections after surgery, greatly improving patient comfort and satisfaction. Consequently, it effectively reduces the occurrence of postoperative complications in patients with urethral strictures, benefiting the surgical treatment outcomes. This study aims to observe the nursing application of multifunctional protective pants in patients with complex urethral strictures, evaluate their role in reducing complications during the nursing process, and improving the success rate of surgery. The following report provides details.

2.1 General materials

A total of 50 patients who underwent posterior urethral surgery at our hospital from December 2021 to June 2023 were randomly selected as the study population. The patients were divided into the experimental group and the control group using the envelope randomization method. The control group consisted of 25 cases, with an age range of 22 to 66 years and a mean age of (39.4 ± 9.9) years. The experimental group consisted of 25 cases, with an age range of 17 to 60 years and a mean age of (36.2 ± 10.9) years. The differences between the general data of the two groups were not statistically significant (P > 0.05) and were comparable (Table 1). All patients and their family members were informed about the study and provided informed consent. The study protocol was approved by the medical ethics committee of our hospital.

2.2 The fabrication and production of the multifunctional protective pants

The multifunctional protective pants were invented by the Department of Urology of Sixth People's Hospital of Shanghai and developed by JIQU Medical Technology Co., Ltd., commissioned. These protective pants are used for postoperative treatment of urethral strictures which are designed to fit closely to the patient's buttocks, and the straps are threaded through the patient's groin and adhered to the waistband to provide compression and dressing for the wound. The tightness of the straps can be adjusted according to the patient's condition, effectively exerting pressure on the wound, inhibiting fluid leakage, promoting hemostasis, and facilitating tissue adhesion to promote wound healing, thus aiding in the postoperative recovery of the patient's wound. The side pockets of the pants contain padding, which enhances comfort and provides a cool local microenvironment in the perineal area, reducing pain and suppressing abnormal penile erection after surgery, thereby promoting wound healing. Additionally, the protective pants are equipped with features such as a hook for suspending a urinary catheter, making it convenient for patients to carry a urine collection bag (Fig. 1A-E).

2.3 Methods:

The control group took routine care after urethral stricture surgery. The diet should consist of high-protein, high-calorie, easily digestible foods, with an appropriate intake of vegetables, fruits, and coarse grains. Defecation was ideally be controlled until 3 days after surgery, as straining during defecation too early will increase wound tension, leading to urethral fistula and the leakage of urine through incompletely healed wounds. Besides, patients should be advised to drink plenty of water to increase urine volume, which helps flush the urinary tract and prevent residual urine from accumulating in the urethra, thus reducing the risk of wound infection. After surgery, the urinary catheter and negative pressure drainage tube were properly secured to ensure unobstructed drainage and prevent compression, bending, or detachment of the tubes. If the urine appears turbid or contains flocculent particles, the doctor was notified immediately for further evaluation. The urinary catheter was connected to a sterile anti-reflux urine collection bag, which was replaced twice a week, strictly according to aseptic operation. Postoperative antimicrobial therapy was administered to prevent infection and pressure should be reduced on the exposed wound. Furthermore, attention was paid to the blood supply to the perineal skin and the degree of scrotal swelling, observing for the presence of secretions or hematoma symptoms. The urethral orifice was cleaned with saline-soaked cotton balls twice daily to maintain cleanliness and dryness in the perineal area. In addition, postoperative administration of relevant antibiotics should be followed according to the physician's instructions. If no seepage or exudate occurs for 3–5 days after surgery, there is no need to change the dressing for penile compression. Undoubtedly, patient temperature, pain, infection, poor wound healing, and bleeding should be recorded accurately.

Patients in the experimental group wore protective pants immediately after urethral stricture surgery. In addition to the routine care provided to the control group, the experimental group received health education and guidance on how to wear and remove the protective pants for both patients and their family members to facilitate daily caregiving.

2.4 Observation indexes:

During the postoperative period until discharge, the occurrence of bleeding, abnormal body temperature, and other conditions in patients were observed in combination with routine blood tests and calcitoninogen results to assess patient’s infection status. Pain assessment for patients was conducted using a numerical scoring system during the three days and nine shifts handover.

2.5 Patient-reported outcome measures

The PCQ designed for this study mainly consists of two main areas: patient subjective perception and comfort (Q1-4) and contribution to care and prognosis (Q5-10). The PCQ was completed by patients at follow-up.

2.6 Statistical methods:

Data analysis and processing were performed using SPSS 22.0 statistical software. Measurement data were expressed as (χ¯±s), and enumeration data were analyzed using (χ²) test. The t-test was used to assess differences, and a p-value less than 0.05 was considered statistically significant.

3.1 The baseline of the random controlled patients

In total, 50 patients were enrolled between December, 2021, and June, 2023. Patients were randomly divided into two groups, the experimental group and the control group, with 25 patients in each group. Table 1 summarizes the clinical characteristics and baseline of various patients in each group, including age, history of urethral surgery, length of urethral defect, number of patients with dissection of Cavernous septum and splitting of pubic bone, intraoperative bleeding volume and follow-up time. There were no statistically significant differences in clinical characteristics and baseline between the two groups (Table S1).

3.2 Comparison of the postoperative bleeding between patients in the control group and the experimental group

The incidence of bleeding was remarkably less than that of the control group on the first postoperative day, and the difference was statistically significant (P < 0.05). The time to remove negative pressure drainage and time to walk and hospitalization were decreased significantly (Table S2).

3.3 Comparison of postoperative infection between patients in the control group and the experimental group

The incidence of abnormal body temperature, elevated blood leukocytes and procalcitonin, purulent discharge from the urethral orifice, positive secretion culture, and positive urine culture in the experimental group was significantly less than that in the control group within 5 days after surgery, and the difference was statistically significant (P < 0.05) .

The use of multifunctional protective pants effectively reduces complications such as patient pain, infection, poor wound healing, and bleeding during the perioperative period, significantly increasing the success rate of surgery and patient satisfaction (Table 3S).

3.4 The patients’ evaluation of the usage of multifunctional protective pants

Table 4 summarized the PCQ results. In terms of patient subjective perception and comfort, Twenty-three patients (92%) believed that the multifunctional protective pants was better than ordinary underwear and it improved their comfort level. Twenty-two patients (88%) found that it can reduce the time of erection. For promoting care and prognosis, twenty-five patients (100%) thought these pants are convenient for doctors to change fresh dressing and observation of wounds. What’s more, twenty-two patients (88%) also believed that it can help to reduce the incidence of bleeding and tape allergies (Table S4).

3.5 Comparison of complications between patients in the control group and the experimental group two months after surgery.

Complication results are shown in Table 5. There were no significant differences in the rates of self urination, erection function and urinary incontinence two months after surgery. In comparison with the control group, the incidence of scrotum edema, skin allergic blisters, dropping of the dressing after walking and erection pain after surgery in experimental group were decreased significantly (P < 0.05) (Table 1).

Table 1

Comparison of syndromes between patients in the control group and the experimental group(cases) two months postoperatively.
Postoperative complications	Occurance	Experimental group \| Control group, n(%)		Total	χ2	p
Postoperative complications	Occurance	Experimental group (n = 25)	Control group (n = 25)	Total	χ2	p
Scrotum hematoma	Yes	1(4.00)	5(20.00)	6(12.00)	3.030	0.082
Scrotum hematoma	No	24(96.00)	20(80.00)	44(88.00)	3.030	0.082
Scrotum edema	Yes	7(28.00)	20(80.00)	27(54.00)	13.607	0.000**
Scrotum edema	No	18(72.00)	5(20.00)	23(46.00)	13.607	0.000**
Skin allergic blisters	Yes	4(16.00)	25(100.00)	29(58.00)	36.207	0.000**
Skin allergic blisters	No	21(84.00)	0(0.00)	21(42.00)	36.207	0.000**
Dropping of the dressing after walking	Yes	0(0.00)	12(48.00)	12(24.00)	15.789	0.000**
Dropping of the dressing after walking	No	25(100.00)	13(52.00)	38(76.00)	15.789	0.000**
Self urination two months after surgery	Yes	22(88.00)	20(80.00)	42(84.00)	0.595	0.440
Self urination two months after surgery	No	3(12.00)	5(20.00)	8(16.00)	0.595	0.440
Post-operative erection pain	Yes	10(40.00)	25(100.00)	35(70.00)	21.429	0.000**
Post-operative erection pain	No	15(60.00)	0(0.00)	15(30.00)	21.429	0.000**
Erection dysfunction 2 months postoperatively	Yes	22(88.00)	23(92.00)	45(90.00)	0.222	0.637
Erection dysfunction 2 months postoperatively	No	3(12.00)	2(8.00)	5(10.00)	0.222	0.637
Urinary incontinence 2 months postoperatively	Yes	1(4.00)	2(8.00)	3(6.00)	0.355	0.552
Urinary incontinence 2 months postoperatively	No	24(96.00)	23(92.00)	47(94.00)	0.355	0.552
* p < 0.05. ** p < 0.01

The treatment of urethral stricture mainly involves open surgery^[8–11]. Currently, there is extensive research on preoperative preparation and intraoperative procedures^[12], while postoperative care and recovery remain relatively understudied^[13]. Postoperative care and preoperative preparation, as well as intraoperative procedures, are equally important in the management of urethral strictures and are integral parts of the treatment process^[14–17]. They are crucial for surgical outcomes and should not be overlooked. If there is hematoma or inflammation in the urethral wound after surgery, or if the penis is abnormally erect resulting in excessive urethral tension, it may be necessary to perform a second surgical intervention to control bleeding, which may lead to failure in severe cases. Postoperative urethral wounds require compression dressings to inhibit tissue fluid leakage, promote hemostasis, and increase inter-tissue adhesion thereby promoting wound healing. Having a suitable urethral compression dressing shorts that also provide a cool local microenvironment in the perineal area can address these issues and bring significant benefits to patients.

In the past, the conventional method for post-urethral and perineal surgery involved traditional gauze and adhesive bandage dressings. However, this approach had several disadvantages. The adhesive bandage was prone to loosening, and its elongated shape did not provide uniform mechanical support to the perineum and scrotum. As a result, postoperative perineal hematoma often occurred, requiring secondary surgical interventions to control bleeding. This not only caused unnecessary physical and psychological trauma to patients but also imposed economic burdens and increased doctor-patient conflicts. In light of these issues, we have developed a multifunctional equipment that addresses bleeding complications following urethral reconstruction surgery from two perspectives. The first advantage lies in the adjustable perineal compression device. By adjusting the mechanical intensity of the perineal material through the use of straps, it effectively compresses the wound, reducing bleeding and minimizing tissue edema, thus promoting wound healing. Another advantage is the proactive approach to address erectogenic corpus cavernosum bleeding. We have incorporated programmable cooling ice packs into the perineal support material to cool the penis and urethral corpus cavernosum, reducing blood flow perfusion within the corpus cavernosum and effectively resolving corpus cavernosum bleeding. Furthermore, the protective pants are equipped with small features such as hooks for suspending urinary catheters, bladder fistula tubes, urine collection bags, and negative pressure drainage tubes. These designs facilitate the convenient carriage of these catheters by patients while preventing their accidental dislodgement. This protective hemostatic equipment is suitable for various perineal surgeries such as urethral stricture, testicular sheath effusion, testicular torsion, and perineal injuries, providing postoperative protection. In addition to its hemostatic function, it can accommodate various auxiliary devices, such as highly sensitive temperature and humidity pressure sensors, and erectile and urinary control nerve recovery stimulators. This invention significantly improves the safety of urethral surgeries and enables multifunctional patient recovery from a postoperative care perspective, making it an innovative breakthrough in both domestic and international contexts.

This study revealed that the incidence of postoperative penile hematoma in the experimental group was significantly lower than that in the control group (P < 0.05), indicating that the protective pants effectively exerted pressure on the wound. Within 5 days after surgery, the experimental group exhibited significantly lower rates of abnormal body temperature, elevated blood leukocytes and procalcitonin, purulent discharge at the urethral orifice, positive secretion cultures, and positive urine cultures compared to the control group. These differences were statistically significant (P < 0.05), which suggests that the protective pants reduced the occurrence of postoperative infections.

In conclusion, the protective pants effectively improve the occurrence of postoperative complications in patients with urethral strictures, benefiting the recovery of patients undergoing complex urethral reconstructive procedures and aiding in their prompt rehabilitation, thereby enhancing the success rate of the surgery. Nurses find the implementation of the pants feasible in practical settings, making it worthwhile to further promote their use.

Consent for publication

All the authors got consent for publication.

Contributions

KZ: project development, manuscript editing. LC: manuscript writing, data collection. WF: manuscript writing, data management. BC: data collection. SC: data analysis. QF: project development, supervision.

Conflicts of interest

The authors declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.

Research involving human participants

This study was approved by internal institutional review board.

Informed consent

Informed consent was obtained from all individual participants included in the study.

Funding

National Natural Science Fund of China (grant no. 82170694, 81700590), the Shanghai Jiao Tong University Biomedical Engineering Cross Research Foundation (grant no. YG2022ZD020, YG2017QN15), Shanghai health committee(20184Y0053), Jiangsu Key R&D Plan (BE2017664), Shanghai "Rising stars of medical talent" Youth development program, Shanghai Jiao Tong University K. C. Wong Medical Fellowship Fund.

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No competing interests reported.

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The nursing application of multifunctional protective pants after posterior urethral stricture surgery: A randomized clinical trial

Status:

Version 1

Abstract

Figures

1 Introduction

2 Materials and Methods

2.1 General materials

2.2 The fabrication and production of the multifunctional protective pants

2.3 Methods:

2.4 Observation indexes:

2.5 Patient-reported outcome measures

2.6 Statistical methods:

3 Results

3.1 The baseline of the random controlled patients

3.2 Comparison of the postoperative bleeding between patients in the control group and the experimental group

3.3 Comparison of postoperative infection between patients in the control group and the experimental group

3.4 The patients’ evaluation of the usage of multifunctional protective pants

4 Discussion

Declarations

References

Additional Declarations

Supplementary Files

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