Clinical Observation of Double Percutaneous Nephrostomy Combined with Ureter Occlusion Stent for Treating Cervical Cancer Complicated with Vesicovaginal Fistula

Abstract

Background:

To evaluate the efficacy of double percutaneous nephrostomy (PCN) combined with ureter occlusion stent for treating cervical cancer complicated with vesicovaginal fistula (VVF).

Materials and Methods:

A retrospective analysis was performed for 12 patients with cervical cancer complicated with VVF. Regardless of surgical resection, radiotherapy alone or combined chemoradiotherapy were carried out in all patients. After VVF was diagnosed by gynecological examination, imaging, and cystoscopy, concurrent double PCN and ureter occlusion stent implantation were performed for all patients.

Results:

All patients successfully received ureter occlusion stent implantation after nephrostomy. The success rate of nephrostomy and stent placement was 100% (12/12). After intervention, urinary fistula immediately disappeared in all patients. One week post-surgery, bilateral hydronephrosis disappeared in 4 patients, and their renal insufficiency and renal function returned to normal. One month after operation, 6 patients with genital eczema or ulcer and 5 patients with urinary tract infection were cured. During follow-up, there were no recurrence in urinary fistula, renal dysfunction, and other complications.

Conclusion:

Double PCN combined with ureter occlusion stent could effectively treat cervical cancer complicated with VVF hydronephrosis, urinary tract infection, and renal insufficiency and contribute to alleviate all kinds of clinical discomfort.

Introduction

Vesicovaginal fistula (VVF) is an abnormal fistula between the bladder and vagina, inducing urine continuously into the vaginal fornix, whose main causes are obstetric injury, intervention, infection, congenital anomalies, intervention, malignant tumor growth, and chemoradiotherapy for malignant tumor.^1,2 VVF is the most serious complications in obstetrics and gynecology intervention, although it is not life-threatening complications, it significantly reduces the quality of life of patients.³ As for uterine benign disease after hysterectomy, the rate for occurrence of VVF was 0.08% −0.3%.^4
–6 After radical intervention for gynecological malignancies, concurrent chemotherapy made the risk of VVF exceed 1%.⁷ High prevalence of early marriage and childbearing, low social status, malnutrition, and poor uptake of conventional antenatal care were considered to be the risk factors for the development of VVF.

External trauma, such as penetrating, pelvic fracture and sex, foreign body, obstructed labor, uterine rupture, and caesarean section injury to bladder were the main reasons of VVF. Since VVF that is caused by benign lesion intervention, surgical repair is the main method for treatment, including vaginal repair and abdominal repair, and ileal conduit diversion can be performed in patients with repair failure.^3,7 Comparing VVF caused by chemoradiotherapy in cervical cancer with VVF caused by nonradioactive damage, individual treatment, complex surgical procedures, and even multiple intervention were often required owing to poor fistula blood supply, slow wound healing, and high surgical failure rate.^3,8

High recurrence rate, high readmission rate, and long-term recovery time often increased the economic burden of patients and decreased the quality of life of patients.⁹ To improve the quality of life of patients, reduce the pain of patients and medical expenses, and explore methods that can invasively control VVF caused by radiotherapy, double percutaneous nephrostomy (PCN) combined with ureter occlusion stent was used to treat patients with VVF after radiotherapy of cervical cancer in this study.

Materials and Methods

Patient information

Retrospective analysis was performed for VVF patients from February 2016 to February 2017. After gynecological examination, cystoscopy (Fig. 1A), and computed tomography urography (CTU) (Fig. 1B), 12 patients were diagnosed with cervical cancer complicated with VVF, with age of 46–62 years (53.8 years). The patients were staged as follows at initial treatment (operation or chemotherapy) according to International Federation of Gynecology and Obstetrics: II b (5), III a (4), and IV a (3). Five patients with stage II b diagnosed as cervical cancer received hysterectomy and pelvic lymph node dissection, and total 50 Gy pelvic radiotherapy was performed after intervention. The 5 with stage II b patients achieved complete remission (CR) before urinary fistula occurred. Four patients with stage III received hysterectomy and pelvic lymph node dissection after 50 Gy pelvic radiation therapy and 20 Gy intravaginal radiotherapy at the same time. Two patients achieved CR and two patients achieved partial response (PR) before urinary fistula occurred. Three patients with stage IVa were treated with 50 Gy pelvic radiotherapy and concurrently systemic chemotherapy. All the 3 patients were in stable disease station.

FIG. 1.

The urinary fistula was found in patients who were 45 years old and IIIb cervical cancer at 1 month after chemoradiotherapy. (A) Cystoscope indication: 2 × 3.5 cm fistula can be seen at bottom of right side wall of the bladder, and stuffed gauze blocks can be seen inside the vagina through the fistula (arrow). (B) CTU sagittal view: vaginal wall was thickened and invaded posterior wall of the bladder, bladder aggregation contrast agent overflowed in vitro through the fistula. CTU, computed tomography urography. Color images are available online.

Urinary fistula occurred 2–9 months after radiotherapy (Table 1). When all patients were diagnosed with VVF and their stages all were IV, the imaging prompted tumor recurrence. The tumors in 12 patients involved bladder, of which tumors in 2 patients invaded the rectum. This study was approved by the Institutional Review Board in accordance with approved guidelines of the First Affiliated Hospital, Zhengzhou University. Informed consent was obtained from each participant.

Table 1.

Summary of Patient Basic Information

Patients	Age	Tumor staging at initial visits	Initial treatment plan	Sequential therapy	The emergence time of VVF after radiotherapy	Tumor staging at diagnosis of VVF	Tumor invades the rectum
1	46	II b	Radical hysterectomy	Pelvic irradiation	2	IVa	N
2	47	II b	Radical hysterectomy	Pelvic irradiation	3	IVa	N
3	53	II b	Radical hysterectomy	Pelvic irradiation	5	IVa	N
4	49	II b	Radical hysterectomy	Pelvic irradiation	4	IVa	N
5	53	II b	Radical hysterectomy	Pelvic irradiation	5	IVa	N
6	55	IIIa	Pelvic irradiation and intravaginal radiotherapy	Radical hysterectomy	6	IVa	N
7	61	IIIa	Pelvic irradiation and intravaginal radiotherapy	Radical hysterectomy	7	IVa	N
8	62	IIIa	Pelvic irradiation and intravaginal radiotherapy	Radical hysterectomy	8	IVa	N
9	55	IIIa	Pelvic irradiation and intravaginal radiotherapy	Radical hysterectomy	9	IVa	N
10	56	IVa	Chemotherapy combined with pelvic radiotherapy	N	4	IVa	Y
11	47	IVa	Chemotherapy combined with pelvic radiotherapy	N	3	IVa	N
12	61	IVa	Chemotherapy combined with pelvic radiotherapy	N	5	IVa	Y

N, No; Y, Yes.

VVF, vesicovaginal fistula.

Methods

After admission, routine methylene blue test + cystoscopy was performed for patients to obtain the number, size, and location of VVF, whether they were combined with ureteral vaginal fistula, rectal vaginal fistula, and other special circumstances. A unified brand of adult baby diapers was used, and the number of baby diapers were measured 24-h before use. The baby diapers were weighed before and after use, and the 24-h fistula urine mass was calculated. The morphology of double kidneys, ureteral route, urinary function of double kidneys, and invasion situation of tumor on the urinary system were defined by CTU, and a further treatment program was developed to determine whether double PCN combined with ureter occlusion stent could be performed or not.

Stent

According to the preliminary research experience of the center,¹⁰ the diameter and length of bullet-type ureteral occlusion stent was designed before intervention based on the shape and route of the ureter. General diameter of stent was greater than 15% to 25% diameter of ureter, and the stent diameter was set at 8 mm or 10 mm in advance. The main body of the stent is tubular with the head end blocked; the overall shape is designed as a bullet for blocking the ureter and reducing the friction between the stent and the ureter. The stent material was 0.16 mm diameter nickel-titanium temperature memory alloy wire, and the stent was coated with a double-layer polyethylene film. The length of the film was designed as 30 mm, which could prevent the hyperplasia of ureteral mucosa and block the ureter tightly. To prevent displacement, 10 mm of the stent end was reserved to increase contact and friction force with the ureteral wall.

Surgical procedure

Patients were in a bilateral tilt position of 45 degrees, and the 21G Chiba needle was used to puncture the kidney after the successful DynaCT location for puncture point of the DSA (ArtisZeego, Siemens Health Care, Germany). After successful puncture, 0.018 inch guide wire was introduced by Chiba needle, and puncture package was introduced by the guide wire. Then, through the outer sleeve, 0.035 inches of water film guide wire were introduced, and 5FKMP was exchanged through the outer sleeve. The catheter guide wire was fitted into the bladder, KMP catheter radiography was back, VVF diagnosis was confirmed (Fig. 2A), and route and diameter of ureter were defined to block the release position of stent. The KMP catheter was introduced into the 0.035 inch and hardened guide wire. The guide wire was introduced into the 10F arterial sheath and introduced into bullet ureteral occlusion stent delivery device, and was placed in patients with bilateral ureter successively (Fig. 2B, C). After the stent conveyor was back, 10.2F external drainage tube was introduced into hardened guide wire, and drainage tube was looped into bilateral renal pelvis. Review angiography of outer drainage tube was performed to confirm whether the bilateral ureter flow was well blocked (Fig. 2D).

FIG. 2.

Same as patient in Figure 1. (A) The cystography prompted VVF through the anterograde nephrostomy, and visible contrast agent was along the sinus to flow in vitro. (B, C) Two bullet stents were placed in middle and lower portion of bilateral ureter. (D) Double nephrostomy was introduced by original puncture channel, and fluoroscopy showed that bilateral ureteral obstruction was well. VVF, vesicovaginal fistula.

Monitoring and follow-up

The pain score, physical status (ECOG) score, and quality of life score (KPS) were used to assess the patient's pain, activity status, and quality of life before and after intervention. The main observation indicators were as follows: after stent implantation, side hole position was defined by fistula angiography, and it shall be avoided that side hole was back to the inside renal parenchyma or outside kidney; external drainage tube was bandaged and fixed in comfortable position for patients, and long-term delivery of external drainage tube caused discomfort to patients shall be avoided; the velocity of urine drainage was observed and whether there was hematuria, determining that the double PCN was smooth drainage for renal urine.

After intervention, treatments such as anti-inflammatory, antispasmodic, and hemostasis were performed for patients, and vital signs of patients were observed for 24-h. If 24 h after intervention, hematuria of patients could not be controlled and hemoglobin continued to reduce it shall be considered to be changed to 12F external drainage tube or renal artery angiography + hemorrhage arterial embolization if necessary. The color of urine, volume of drainage, and removed or prolapsed drainage tube of bilateral fistula tube were observed at 5–7 d after intervention. The electrolytes of liver and kidney function, blood routine, coagulation function, and urine routine were reviewed after 5–7 d, and preoperative comparison analysis was performed for improvement of renal function. The double kidneys, ureter and bladder CT, electrolytes of liver and kidney function, blood routine, and urine routine were reviewed at 1, 3, and 6 months after discharge.

Statistical analysis

All data were expressed as mean ± standard deviation or percentage. Statistical analysis was performed by SPSS 18.0 (SPSS, Inc., Chicago, IL). The quantitative data were analyzed by bilateral t test. p < 0.05 was statistically significant.

Results

Preoperative data and prognosis

In a total of 12 patients cervical cancer was diagnosed combined with VVF diagnosis by gynecological examination, CTU, and cystoscopy. According to CTU results, ureteral occlusion stent was designed as 10 mm of diameter and 40 mm of length. After cystoscopy, diameter of VVF was 4.2 ± 1.8 cm, 2 patients were found to have VVF combined with rectal vaginal fistula. The fistula histopathology reports were taken from all patients, and the results indicated four cancerous tissue cases and eight fibrous connective tissue cases. A total of 24 ureteral urinary occlusion stent were successfully implanted for 12 patients after successful one-time renal fistula, and the success rate of stent placement was 100% (12/12). The DynaCT scan of kidneys was performed immediately after intervention, and complications such as puncture tract hematoma, perirenal effusion, or hematoma were no found.

After intervention, urinary fistula immediately disappeared in all patients. One day after intervention, frequent tingling of urethral orifice and/or perineal pain disappeared in all patients. One week after intervention, hydronephrosis disappeared in 4 patients and normal renal function was found in 4 patients with renal dysfunction. Ileostomy was performed for 2 patients with rectal vaginal fistula after 1 week of intervention. One month after intervention, 6 patients with perineal eczema or ulcer and 5 patients with urinary tract infection patients were cured within 1 month after perineal cleaning, anti-inflammatory and symptomatic support treatment.

Compared with 1 week after intervention, renal fistula combined with ureteral occlusion for patients before intervention can effectively reduce the patient pain score (7.8 ± 2.2 vs. 2.5 ± 1.2, p < 0.001), increase the KPS score (65.5 ± 9.5 vs. 87.5 ± 5.0, p < 0.001), increase the ECOG score (73.5 ± 1.2 vs. 2.1 ± 0.5, p < 0.01), significantly reduce pieces of diapers in daily use (21.4 ± 6.5 vs. 2.7 ± 0.5, p < 0.001), and completely control urinary fistula (854.5 ± 127.9 vs. 42.3 ± 16.2, p < 0.001) (Table 2).

Table 2.

Prognosis Evaluation for Patients After Double Percutaneous Nephrostomy and Nephrostomy Combined with Ureteral Stent Implantation

Prognosis evaluation	Before surgery	One week after surgery	p value
Number of white blood cells in urine	7.6 ± 3.9 (5.4, 9.8)	3.5 ± 1.2 (2.8, 4.2)	0.002
Creatinine (μM)	61.3 ± 16.8 (51.8, 70.8)	52.2 ± 17.3 (42.4, 61.9)	0.21
Urea nitrogen (μM)	9.5 ± 2.7 (7.9, 11.0)	7.3 ± 3.2 (5.5, 9.1)	0.08
Number of diapers in daily use (pieces)	21.4 ± 6.5 (17.7, 25.1)	2.7 ± 0.5 (2.4, 2.9)	<0.001
Daily vaginal and urethral exudate (g)	854.5 ± 127.9 (782.1, 926.8)	82.3 ± 16.2 (73.1, 91.5)	<0.001
Pain score	7.8 ± 2.2 (6.6, 9.0)	2.5 ± 1.2 (1.8, 3.2)	<0.001
ECOG score	3.5 ± 1.3 (2.8, 4.2)	2.1 ± 0.5 (1.82, 2.4)	0.002
Quality of life (KPS) score	65.5 ± 9.5 (60.1, 70.9)	87.5 ± 5.0 (84.6, 90.3)	<0.001

Data were presented as mean value ± standard (95% CI).

Intraoperative and postoperative complications

Unilateral renal fistula drainage hematuria was found in 7 patients. Hemostatic treatment was given, and hematuria was stopped within 48 h. Lumbar back pain was found in 2 patients during intervention, remission was obtained after antispasmodic and analgesic treatment, and there was no recurrence of similar symptoms in follow-up process. Nausea and vomiting were found in 1 patient during intervention, remission was obtained after pain and antiemetic treatment; poor appetite was found after intervention, and no treatment was given to alleviate. The displacement of fistula was found in 2 patients after intervention, and urine was oozing from fistula. One side of renal pelvis fistula was off in 1 patient, and drainage tube was adjusted and refixed. After fistula care and maintenance mission were given displacement of fistula and shedding phenomenon have not occurred again.

Follow-up

All patients were followed up for 6–12 months without deaths. During the follow-up, vaginal fistula was not found in all patients, without significant complications such as lower back pain, hematuria, fistula barrier, and renal insufficiency. CT scan was performed at 1, 3, and 6 months after intervention. The stent was in good position, no fixation, fracture, stent, and stent formation. After VVF and VVF related complications were controlled, 9 patients received 4 courses of different kinds of systemic chemotherapy and 3 patients only received 2 courses of different kinds of systemic chemotherapy and Traditional Chinese Medicine treatment. Tumor staging of all patients had not changed, primary disease of 9 patients who received 4 courses of systemic chemotherapy had no progress, and tumor diameter had increased in the other 3 patients. Postoperative review was performed by cystoscopy and VVF fistula was 3.7 ± 1.5 cm. Compared with VVF before intervention there was no significant difference.

Discussion

VVF has remained a scourge and of public health importance, causing significant morbidity and psychological and social problems to the patient. The method of repair was related with the type and location of the VVF, and the surgeon's training and expertise.¹¹ The timing of treatment and surgical method for VVF were still controversial. The review of 43 literatures on treatment of VVF literature suggested that in the case of persistent bladder drainage, simple fistula required 4–6 weeks for repair, complex fistula required 6–12 weeks for repair, and radioactive fistula required 12 months for repair.⁷ As for robot-assisted VVF repair, 11 of 30 patients had complex VVF, and 27 patients had supratrigonal VVF after intervention.¹² For urinary fistula caused by nonradioactive damage, repair success rate for fistula was 70%–100%.³ However, repair surgery intervention should be performed under general anesthesia. Patients must have conditions that include good wound edge bleeding, tissue fresh, and tension-free sutures.¹³

However, in patients with VVF caused by radiotherapy, there was bladder mucosal congestion and edema, poor flexibility, and the bladder wall blood supply was damaged. Ulceration formed which bled and spread through the bladder wall, causing leakage of urine. Surgical repair was prone to failure, and the symptom of urine leakage recurred.^3,14 A total of 210 patients with VVF caused by radiotherapy after cervical cancer hysterectomy in 40 years of surgical repair were retrospectively analyzed, and the initial success rate for surgical repair was 48.1% (101/210).³

For patients with advanced cervical cancer, elasticity of the bladder wall was poor after radiotherapy, and lack of blood supply caused repair injury and high failure rate.^3,13 Study showed that PCN was responsible for the recovery of renal function in 61.7% of the patients with advanced cervical cancer, leading to interruption of renal replacement therapy in all of those patients.¹⁵ However, most patients after intervention or radiotherapy cannot tolerate intervention repair due to physical weakness. In this case, scholars choose urethral diversion.¹⁶ But the result of VVF repair depended on the experience of the surgeon rather than the used surgical techniques. Twelve patients were defined with recurrence of cervical cancer. Patients and their families could not tolerate up to 12 months of surgical waiting period, but also could not psychologically or physically tolerate a relatively simple ileal conduit diversion. Patients who undergo a supralevator pelvic exenteration are candidates for a low colorectal anastomosis.¹⁷ However, this approach may be associated to an increased risk of anastomotic breakdown or fistula in previously irradiated patients. Gastrointestinal fistulas represent a postoperative event that could be avoided with the proposed pelvic floor and vaginal reconstruction with myocutaneous flaps.¹⁷ Intraoperative radiotherapy is an additional approach particularly in the presence of microscopically positive margins on frozen-section evaluation.¹⁷

According to the surgical urinary diversion and previous research results for bullet stent occlusion bronchial stump fistula,¹⁰ the new concept that ureteral occlusion was combined with nephrostomy was proposed in this study. The difference could not be mainly found in complication rates or quality of life between PCN and ureteral stenting.¹⁸ In this study, a 10 × 40 mm ureteral occlusion stent was designed, 30 mm coating at the front end of the stent was gradually formed into bullet type to tightly block the ureter, and block the urine to flow into the bladder, and 10 mm of the stent end was designed as bare to prevent stent displacement. Nephrostomy was introduced after stent implantation, the urine was drained in vitro, and urinary diversion could be completed by using minimally invasive interventional technology.

Seven patients had short-term mild hematuria after renal puncture. Although DynaCT positioning puncture were used, there was still a great difficulty in puncture normal kidney in the 7 patients. Preoperative infusion of contrast agent was used to better show the kidney calices and pelvis, to prevent puncture through the renal papillae, so as to avoid severe renal puncture bleeding. Twelve patients had 25% (3/12) dislocation and displacement rate of the drainage tube after intervention, and retrospective analysis showed that these were unskilled punctures at initial operation and selection of puncture point in the posterior axillary line and lower part of the kidney, which caused discomfort for patients in supine position, drainage tube fractionize with bed to fall off or displace. The choice of puncture point was near the midline of axillary and middle of the kidney, displacement of drainage tube and prolapse phenomenon appeared.

The management of cervical cancer should be personalized considering the performance status of the patient. It has been reported that despite the higher burden of comorbidities, elderly patients can also benefit from standard treatments in managing their gynecological cancers.¹⁹ It is absolutely necessary to overcome the mental bias of not treating the elderly because they are more fragile and have a lower life expectancy than their younger counterparts. Another study has also reported that prognosis of cervical cancer was poorer in elderly women than in younger women and it might be because of the intensity of treatment.²⁰ Treatment strategies appeared to affect prognosis independently; however, age was not an independent prognostic factor. Administering standard therapy to elderly patients with good performance status, particularly in early cervical cancer, was recommended.

There were some limitations in this study. First, because no relevant research could be referred, the choice of the location of ureteral occlusion stent was limited, and the second narrow top section and shapeless smooth of ureter were selected as stent release site. Second, more treatment experience and related data were needed for effects of stent in this part on long-term foreign body stimulation, ureteral calculi formation, and common iliac artery. Third, whether the quality of life of patients could be improved for long term and survival of patients could be prolonged, multicenter and prospective studies were needed to verify the safety and effectiveness of intervention. Fourth, the urinary fistulas of all patients were completely relieved after intervention, vital signs were stable, and patients could tolerate further chemotherapy or interventional treatment mainly uterine artery angiography chemotherapy, so the choice of postoperative treatment program still needed further study.

In short, for cervical cancer complicated with VVF caused by radiation injury, if the patient could not tolerate intervention repair and failure of surgical repair, and refuses to repair intervention, the double PCN combined with ureter occlusion stent could serve as a new urinary diversion, which is minimally invasive, safe, and rapid to relieve urinary fistula, hydronephrosis, urinary tract infection, and renal insufficiency caused by VVF, help to improve quality of life and physical power of patients, and relieve a variety of clinical discomfort.

Footnotes

Authors' Contributions

Xu-Hua Duan and Feng-Yao Li was the guarantor of integrity of the entire study and helped in the article preparation. Xu-Hua Duan and Xin-Wei Han carried out the study concepts and clinical studies. Xu-Hua Duan, Xin-Wei Han, and Gang Wu carried out study design and article review. Xin-Wei Han and Gang Wu helped in the definition of intellectual content and article editing. Jian-Hao Zhang and Yu-Dong Tian carried out literature research; Xu-Hua Duan and Yan-Cang Zhang carried out experimental studies; Xu-Hua Duan, Yu-Dong Tian, and Yan-Cang Zhang carried out data acquisition; Yu-Dong Tian and Yan-Cang Zhang carried out data analysis; Gang Wu and Jian-Hao Zhang helped with statistical analysis.

Ethics Approval and Consent to Participate

The study was approved by the relevant Ethics Committee. Informed consent was obtained from all participants.

Consent for Publication

Informed consent was obtained from all participants.

Availability of Data and Material

The datasets used or analyzed during this study are available from the corresponding author on reasonable request.

Disclosure Statement

No competing financial interests exist.

Funding Information

This study was supported by The National Natural Science Foundation of China (No. 81401494).

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