A significant proportion of patients develop urinary incontinence early after radical prostatectomy. Posterior reconstruction of supporting tissues has been found to reduce incontinence in open and conventional laparoscopic prostatectomy series.
To investigate whether our version of a posterior musculofascial reconstruction will reduce early incontinence and have a beneficial effect on patients’ quality of life (QoL).
Design, setting, and participants
One hundred seven consecutive patients undergoing primary robot-assisted radical laparoscopic prostatectomy (RALP) performed by a single surgeon at one tertiary referral oncology institution were alternately assigned (not randomised) to intervention (n
RALP with median fibrous raphe reconstruction (MFRR) followed by formation of the urethrovesical anastomosis (intervention group) versus standard anastomosis without posterior reconstruction (control group).
Measurements included incontinence at baseline and 3-mo intervals; QoL as measured by a simple questionnaire, the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life–Core 30 (QLQ-C30), and Prostate Cancer Module (PR25) questionnaires preoperatively and at 6 mo postprocedure; tumour characteristics; operative time; fascial preservation score; duration of catheterisation; and anastomotic leakage on cystogram.
Results and limitations
For intervention and control groups respectively, mean catheter duration was 11.74 d and 12.74 d (p
No significant difference in any of the analysed outcome measures was observed. Posterior reconstruction of the musculofascial complex does not appear to improve early urinary incontinence after RALP.
Keywords: Prostatectomy, Laparoscopic surgery, Robotic surgery, Urinary incontinence.
Urinary incontinence of varying magnitudes is a common complication following radical prostatectomy, regardless of the method by which it is performed , , and . Usually this incontinence is transient and, without specific treatment, will improve in 85–97% of cases to satisfactory levels by 1 yr  and . However, in open prostatectomy series, it has been demonstrated that posterior supporting sutures, aiming to oppose the Denonvillier's fascia/urethral rhabdosphincter complex behind the vesicourethral anastomosis, can improve early continence rates from 46% to 85% at 90 d . Similarly favourable results have also been demonstrated at the same institute in conventional laparoscopic radical prostatectomy . The manoeuvre itself adds minimal time to the overall procedure, has low morbidity, and is easy to perform.
Few controlled studies, however, have demonstrated its benefit in robot-assisted radical laparoscopic prostatectomy (RALP). Nguyen et al investigated the use of posterior reconstruction of Denonvillier's musculofascial plate in 32 patients compared with a historical control group. In that study, 24 prostatectomies were performed by conventional laparoscopy, and 8 were robotically assisted. Incontinence at 6 wk postoperatively was reduced from 56% to 17% . Recently a larger randomised controlled trial was conducted by Menon et al  using a double-layered anastomosis in men undergoing RALP. This included the creation of a posterior plate incorporating Denonvillier's fascia and the posterior rhabdosphincter, and then continuing this suture line circumferentially anteriorly up to the 11 o’clock and 1 o’clock positions, creating a reinforcing pubovesical collar around the inner urethrovesical anastomosis. This technique, however, did not result in an improvement in continence rates ≤30 d postoperatively over controls.
Given the increasing utilisation of RALP worldwide , any relatively simple method that reduces morbidity from incontinence and improves patient satisfaction would obviously be welcomed. The impact on quality of life (QoL) from this type of intervention has been the subject of limited study. We therefore set out to perform a randomised controlled trial to investigate whether our version of a posterior musculofascial reconstruction would reduce early incontinence and have a beneficial effect on patients’ QoL.
2. Methods and patients
Ethics committee approval was obtained from our institute. All men were continent for urine prior to surgery (no involuntary urine loss of any kind) and had not undergone transurethral resection of the prostate. There were no exclusions. Patients were alternately assigned to the new modified RALP procedure with median fibrous raphe reconstruction (MFRR) and to the conventional RALP without MFRR (control) on the day of their procedure. Patients were blinded as to group allocation. Informed consent was obtained from all patients, and all underwent the assigned treatment by a single surgeon with experience in RALP of >50 cases at the start of the study.
2.1. Power analysis
A two-group continuity corrected χ2 test with a 0.05 two-sided significance level would have 90% power to detect the difference between the observed involuntary urine loss (70% incontinence rate at 3 mo in controls) and a theoretical 35% incontinence rate (odds ratio: 0.231) with the new intervention when the sample size in each group was 47. Between October 2007 and November 2008, 107 consecutive patients scheduled for RALP at our institution were eligible to participate in our study, surpassing this threshold.
Baseline data collected included predictors that may alter continence, including age, tumour stage, grade, prostate-specific antigen (PSA) level, and the fascia preservation (FP) score, representing the extent of preservation of fascia around the prostate (0, nil; 12, whole circumference) .
2.2. Surgical procedure
Conventional RALP has been described elsewhere extensively . Briefly, a six-port transperitoneal approach was used with a four-armed da Vinci S robot (Intuitive Surgical, Inc, Sunnyvale, CA, USA). After dissection of the prostate base from the bladder neck (the bladder neck was not routinely spared), the seminal vesicles and vasa were ligated and divided. The lateral pedicles were then divided and nerve sparing was performed if deemed indicated according to tumour characteristics (any form of nerve preservation in 71.6% and 64.8% in intervention and control groups, respectively, p
A lymph node dissection was performed in men with a nomogram-determined risk of >10% for nodal metastases. In the MFRR intervention group, a running monocryl 2-0 anchoring suture was placed approximating the distal cut Denonvillier's fascia and the median fibrous raphe dorsal to the urethral rhabdosphincter. Completion of the urethrovesical anastomosis (2-0 monocryl double-armed on UR-6 needles, continuous) followed in both groups. The technique was substantially similar to that described by van Velthoven et al . The anastomosis was leak tested, and if a leak was found, extra sutures were placed. No drain was placed prior to closure.
Routine postoperative care was administered and included a cystogram performed on the tenth postoperative day. If no significant leak was detected (as determined by a urologist), a trial of void was conducted. These results were recorded. A doctor administered a questionnaire (Table 1); recording of continence data was completed preoperatively and then at 3 mo postprocedure. Both the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life–Core 30 (QLQ-C30)  and the Prostate Cancer Module (PR25)  questionnaires were administered preoperatively, and at 6-mo intervals postoperatively. Any involuntary urine loss or pad use was chosen as the definition of incontinence, as this was strongly correlated with several domains of the EORTC-QLQ-C30 . Blinding of the evaluating physician was not possible; however, nurse practitioners checking patients in the outpatient follow-up were blinded for the assigned group, and only they administered the questionnaires.
|Score||Degree of incontinence|
|1||No involuntary urine loss during the last week|
|2||Loss of urine in drops during exercise of strain, no pad use|
|3||Loss of urine of any kind requiring at most one pad a day|
|4||Loss of urine of any kind requiring more than one pad a day|
Statistical analysis was performed using SPSS v.15 (SPSS Inc, Chicago, IL, USA). Fisher z test and t test were used for continence score and comparison of mean values, respectively. A p value <0.05 was considered the statistical significance level.
A comparison of baseline characteristics between the two groups is presented in Table 2. Importantly, there were no significant differences in body mass index, clinical or pathologic tumour stage and grade, preoperative PSA, number of patients requiring lymph node dissection, or nerve/fascia sparing as assessed by the FP score. Secondary outcome data are presented in Table 3. Operative time was not statistically different, reflecting the relatively few minutes of extra time the MFRR takes to complete (p
|Age, yr||60.4 (7.8)||60.8 (9.1)||0.70|
|Prostate size, cm3||48.1 (23)||48.4 (43)||0.86|
|Preoperative PSA, ng/ml||7.9 (9.1)||10.7 (11.2)||0.55|
|BMI, kg/m2||25.9 (4.2)||26.1 (3.8)||0.54|
|cGleason <7, ≥7, %||63, 37||75, 25||0.15|
|pGleason <7, ≥7, %||51, 49||57, 43||0.91|
|cT1, 2, 3, %||25, 69, 6||33, 59, 8||0.45|
|pT2, 3, 4, %||76, 19, 5||69, 23, 8||0.36|
|Outcome measure||No MFRR||MFRR||p|
|Operative time, min||110 (31)||122 (44)||0.31|
|FP score, SD||4.09 (2.8)||4.80 (2.9)||0.21|
|Percent leak at 10-d cystogram||8||6||0.28|
|Duration of TUC, d||12.7 (10.1)||11.8 (12.7)||0.47|
3.1. Urinary continence outcome
Median follow-up for urine continence was 9.2 mo for the entire population. No significant differences were detected for leak at cystogram and duration of catheterisation. Data on continence and pad use were available for 54 and 51 men in the test group at 3 and 6 mo postoperatively, respectively, and for 52 and 51 men in the control group at 3 and 6 mo postoperatively, respectively. Continence data are presented in Table 4. No significant differences were recorded for either involuntary urine loss or pad use at both 3- and 6-mo intervals. Fig. 2 depicts the continence rates up to 12 mo postoperatively.
|Incontinence measure||No MFRR||MFRR||p|
|Any urine loss, 3 mo, no. (%)||37 (69)||39 (75)||0.393|
|Any urine loss, 6 mo, no. (%)||26 (51)||22 (43)||0.586|
|Severe urine loss (more than one pad per day), 3 mo, no. (%)||6 (11)||7 (13)||0.649|
|Severe urine loss (more than one pad per day), 6 mo, no. (%)||2 (4)||3 (6)||0.511|
|Any pad use, 3 mo, no. (%)||20 (37)||25 (48)||0.298|
|Any pad use, 6 mo, no. (%)||8 (16)||12 (24)||0.219|
3.2. Quality-of-life assessment
The proportion of patients returning to their baseline QoL scores in all of the EORTC QLQ-C30 and PR25 domains was not significantly different between groups, except for the QLQ-C30 insomnia domain (Table 5). In this domain, the number of patients reporting insomnia postoperatively was higher in the intervention group (p
|QLQ-C30 domains||No MFRR, %||MFRR, %||p|
|1. Physical QoL||80||56||0.128|
|2. Role function||72||76||0.750|
|PR25 domains||No MFRR, %||MFRR, %||p|
|2. Diaper use||100||100||1|
|3. GE complaints||80||84||1|
|4. Metabolic complaints||40||56||0.396|
|5. Sex activity||60||76||0.364|
|6. Sex function||38||41||0.101|
|Urinary tract infection||2||4|
|Urinary retention requiring catheterisation||1||0|
Previous studies have shown promise in improving incontinence by posterior reinforcing sutures of one kind or another. This is in contrast to our present study. The most obvious reason may relate to the differing approach (open/laparoscopic vs robot-assisted surgery). The magnified stereoscopic view and/or the finer, more manoeuvrable instruments may allow better preservation of sphincteric/supporting musculature, hence improving continence. This may obviate the advantage of posterior reinforcing sutures. Tewari et al demonstrated better continence outcomes in RALP (without MFRR) versus the open approach . However, no randomised studies have shown a significant difference in postoperative continence between laparoscopic radical prostatectomy and RALP.
Alternatively, the explanation may lie in subtle differences in operative technique regardless of approach, not only in formation of the reinforcing suture but also in the dissection of the prostate itself or the anastomosis. Unfortunately, there is not enough operative detail in the various reports to make objective comparisons or distinctions.
Our end point (any involuntary urine loss or pad use) is a more stringent definition of incontinence than previous studies have used , and this may account for the measured difference in outcome. We feel our end point is more clinically relevant, as we have demonstrated previously that this definition closely correlates with impact on QoL . When measured using almost the same definition of incontinence as ours (no loss of urine or pad weight: 0), the study by Menon et al  also showed no benefit following anterior and posterior reconstruction versus the control group.
The actual percentages of those continent are difficult to compare; however, the reported rate of continence as measured by Rocco et al  at 3 mo was 46% in their open prostatectomy control group versus 63% (based on no use of pads) in the present study. It may be that the technical aspects of the surgical approach using robotic assistance yield better continence outcomes in any case, lessening the additional benefit of the MFRR. A substantially similar argument was raised in the study by Menon et al , as they had much higher continence rates (74% at 1 mo) than they had expected in their RALP control group.
It is also important to note there was no advantage in preventing anastomotic leakage, at least as evidenced by the routine day 10 cystogram. Certainly visually there appears to be a more substantial tissue complex, under less tension at the time of securing the initial knot of the anastomosis, after the MFRR has been placed. This, however, does not translate into a better postoperative outcome for anastomotic leakage in our experience.
An important difference in our study, as opposed to the majority of other comparable studies, is that ours was a parallel group trial that did not rely on historical controls (Table 7). In fact, the only other significant study using a parallel group design did not find a significant difference in continence outcome in their intervention group . It may be that improvement in overall operative technique with experience may account for some of the difference observed in other similar previous trials, as this would be masked without a true parallel allocation to groups, as noted previously by Guillonneau . Additionally, consistent application of a study protocol and blinding of participants or assessors may have been suboptimal when using historical controls, especially if the study was designed after the control patients had already undergone their procedure.
|Study||No. (intervention arm)||Study design||Continence with correction||Continence without correction||Definition of continence used|
|Tewari et al  and ||182||Historical control||91.3% at 12 wk (total reconstruction); 76.7% at 12 wk (anterior reconstruction)||50.2% at 12 wk||No pad usage or one small liner used for security purposes only|
|Menon et al ||57||Randomised controlled trial||80% at 1 mo; 42% at 1 mo||74% at 1 mo; 47% at 1 mo||No pad or one pad used per day (<30 g/d leakage); based on any leakage|
|Sakai et al ||72||Historical control||67.7% at 3 mo||62.5% at 3 mo||Absence of any need to use sanitary pads or diapers|
|Hollabaugh et al ||60||Historical control||94% at 3 mo||46% at 3 mo||No pad usage or one pad used for security purposes only|
|Rocco et al ||161||Historical control||86.3% at 3 mo||46% at 3 mo||No pad usage or one pad used for security purposes only|
|Nguyen et al ||32||Historical control||56% at 6 wk||17% at 6 wk||No pad usage or one pad used for security purposes only|
|Present study||53||Alternate assignment parallel group study||24% at 3 mo||31% at 3 mo||Any involuntary urine loss or diaper use|
Nerve sparing, utilised to improve postoperative erectile function, has previously been thought to have a bearing on postoperative incontinence . It should also be emphasised that there was no significant difference in the number allocated to each group that underwent nerve sparing or the extent of FP between groups (p
There were several limitations in this study. Although able to evaluate short-term incontinence, follow-up is inadequate at this stage to make any determinations about longer term continence outcomes. We intend to reassess continence data from subsequent 3-mo intervals. Given that previous studies have tended to show a reduced benefit in the long term, we are not hopeful of a significant improvement with longer follow-up for MFRR.
Our study groups were allocated by alternate assignment, which, although a close approximation of randomisation, is not a true randomisation and may bias results. However, there were no exclusions and no crossover between intervention and control groups, so selection bias was minimised. Allocation concealment was not possible as the surgeon knew the patient details and had to perform the procedure himself, depending on allocation. However, patient blinding was maintained, as well as blinding of the assigned group to the outpatient nurse practitioners, both of which may have otherwise led to significant subject bias when questioned about incontinence at follow-up.
Finally, our form of reconstruction is obviously not identical to the form used elsewhere. We do feel that insofar as reapproximation of the musculofascial plate, adequate reconstruction is achieved. Moreover, the alternate, more elaborate method of reconstruction by Menon et al  also showed no improvement in early continence. We feel this reinforces the need for careful consideration before routinely adopting such techniques in surgical practice.
We also acknowledge that the prestudy experience of 50 RALP cases by the surgeon is still well within the learning curve of the procedure; however, given the parallel assignment, this fact should not have favoured one group over the other. This quantity of case experience is also similar to a large proportion of surgeons currently performing RALP, making the study results applicable to many urologists.
Early incontinence is a common and distressing side effect of RALP. Methods to reduce the morbidity of this condition should be encouraged. Other properly controlled studies will be required, rather than retrospective comparisons, to confirm which new techniques can help reduce this complication in routine practice.
Our version of posterior reconstruction of the musculofascial complex does not appear to improve urinary incontinence post-RALP at 3 mo. Further studies (preferably randomised controlled trials) are required to determine if an alternative technique may provide benefit to this troublesome, early, postoperative complication.
Study concept and design: van der Poel, Joshi.
Acquisition of data: van der Poel, Joshi, de Blok, van Muilekom.
Analysis and interpretation of data: van der Poel, Joshi.
Drafting of the manuscript: Joshi, van der Poel, de Blok, van Muilekom.
Critical revision of the manuscript for important intellectual content: Joshi, van der Poel, de Blok, van Muilekom.
Statistical analysis: Joshi, van der Poel.
Obtaining funding: None.
Administrative, technical, or material support: de Blok, van Muilekom.
Supervision: van der Poel.
Other (specify): None.
Financial disclosures: I certify that all conflicts of interest, including specific financial interests and relationships and affiliations relevant to the subject matter or materials discussed in the manuscript (eg, employment/ affiliation, grants or funding, consultancies, honoraria, stock ownership or options, expert testimony, royalties, or patents filed, received, or pending), are the following: None.
Funding/Support and role of the sponsor: None.
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