Preservation of Endopelvic Fascia: Effects on Postoperative Incontinence and Sexual Function – A Randomized Clinical Trial
Aino Siltari PhD; Jarno Riikonen PhD, MD; Teemu J. Murtola PhD, MD
FIRST PUBLISHED: December 22, 2020 – The Journal of Sexual Medicine
Urinary incontinence and sexual dysfunction are two of the most frequent issues faced by men after robot-assisted radical prostatectomy (RALP).
In the past, researchers have suggested that preserving the endopelvic fascia during surgery might improve urinary and sexual function after RALP. However, their studies were not randomized, did not include control groups, and did not have a large number of participants.
The current study is a randomized clinical trial that compares the outcomes of the fascia preservation approach with those of standard RALP surgical procedures.
Patients, Materials, and Methods
The participants were 158 men with localized prostate cancer. Their median age was 63 years. All underwent RALP procedures performed by the same surgeon at Tampere University Hospital in Finland between April 2015 and September 2017.
The men were randomly assigned to one of two groups:
- Fascia-preserving group: 78 men
- Standard RALP surgery (control group): 80 men
The Expanded Prostate Cancer Index Composite (EPIC-26) was used to assess urinary continence and erectile function at baseline and again at three-, six-, and 12-month time points following surgery. The EPIC-26 is scored on a scale of 0 to 100, with 0 indicating no function and 100 indicating normal function.
Clinical characteristic information and surgical data were also collected.
Surgical procedures were described as follows:
“Surgery was carried out with the 4-arm daVinci S robot (daVinci Intuitive Surgical, Sunnyvale, CA, USA). The patients were placed with hips slightly abducted and knees slightly flexed in the 30-degree Trendelenburg position during the surgery. Pneumoperitoneum was established openly by the Hasson technique with a port placed 2 cm above the umbilicus. We used a transperitoneal approach where 4 robot ports and 1 12-mm assistant port were used. Intra-abdominal pressure was 12 mmHg, excluding division of deep venous complex when pressure was raised momentarily up to 20 mmHg until ligation of the veins.
The space of Retzius was dissected and periprostatic fat removed. If the patient was in the standard surgical technique group, the endopelvic fascia were dissected and puboprostatic ligaments were divided as the first step of the mobilization of the prostate. The bladder neck was dissected and opened as close to the prostate as possible. If the patient was in the endopelvic fascia–preserving group, the bladder neck was dissected and opened first and the endopelvic fascia and puboprostatic ligaments were preserved as far as possible. These were cut as close to the prostate as possible only after the rest of the prostate had been mobilized.
In both groups, the seminal vesicles were released. In 33% of the cases, the seminal vesicles were amputated close to the tip to avoid unnecessary force during the dissection. The space between the prostate and rectum was opened. The pedicles of the prostate were clipped using L-size Hem-O-Lok clips and cut using scissors without electrocautery. Nerve sparing, full or partial, was performed on both sides.
In the standard surgical procedure, the dorsal venous complex was transected, the urethra was visualized and transected at the level of the prostatic apex. In the endopelvic fascia–preserving group, the prostatic fascia was dissected from the line of the puboprostatic ligaments and the puboprostatic ligaments were also preserved.
In both groups, dorsal venous complex was secured using a 3-0 V-loc suture. The prostate specimen was placed in a plastic bag. A double-layer posterior reconstruction of the rhabdosphincter was performed with V-loc suture. The urethrovesical anastomosis was sewn using Van Velthoven technique with 3-0 monofilament threads on a UR6 needle (Monocryl; Ethicon, Somerville, NJ, USA). A 2-way silicone Ch 18 Foley urethral catheter with a fenestration at the level of anastomosis was inserted into the bladder. The water tightness of the anastomosis was tested by filling the bladder with 100 ml of saline. A drain was not routinely placed. Finally, the robot was undocked and [sic] plastic bag containing the prostate extracted via a periumbilical incision.”
Baseline population characteristics (e.g., age and BMI) were similar for both groups. Operative time, complication rate, bleeding during surgery, rate of nerve sparing, and positive surgical margins were similar for both surgical methods.
One patient in the control group underwent radiation therapy 11 months after surgery. None of the patients had androgen deprivation therapy.
Mean EPIC-26 scores for overall urinary problems were reported as follows:
|Fascia-Preserving Group||Control Group|
|3-month follow up||74||74|
|6-month follow up||82||82|
|12-month follow up||84||86|
“Thus, the control group had recovered to the baseline at 12 months after operation; however, the endopelvic fascia–preserving group had still around 15% lower EPIC-26 scores than the baseline.”
Urinary leakage was the most commonly reported complication. At the 3-month follow-up point, 46% of the fascia-preserved group and 31% from the control group were experiencing urinary leakage more than once per day. By 12 months, these figures were 22% and 10% respectively.
Mean EPIC-26 scores for overall sexual problems were reported as follows:
|Fascia-Preserving Group||Control Group|
|3-month follow up||26||24|
|6-month follow up||31||31|
|12-5month follow up||43||40|
“Patients had more problems with sexual function than with sexual bother; about half of the patients had suffered problems with erectile function and with the ability to function sexually; however, only about 40% experienced high or moderate overall problems with sexual function.”
In this study, men who underwent fascia-preserving RALP did not have faster or better urinary or sexual outcomes compared to men who underwent standard RALP.
In addition, the fascia-preserving approach did not cause more complications than the standard approach. Duration of surgery, intraoperative bleeding, and time of hospitalization after surgery was similar for both approaches.
The noted limitations included the following:
- Only a minority of patients had had magnetic resonance imaging before surgery, so urethral length and the shape of the prostate apex were not assessed.
- Urinary and sexual function results were based on questionnaires completed by patients; no functional tests were performed.
Compared to the standard surgical approach, the endopelvic fascia-preserving approach to RALP has no effect on postoperative recovery of urinary or sexual function. Therefore, the fascia-preserving approach alone is not recommended over the current standard.