# Impact of Robotic Artificial Urinary Sphincter Implantation in Female Patients on Quality of Life and Patient-reported Outcomes

Alexandre Dubois, Camille Haudebert, Claire Richard, Juan Penafiel, Lucas

Freton, Caroline Voiry, Emmanuelle Samson, Andréa Manunta, Juliette

Hascoet, Benoît Peyronnet

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Alexandre Dubois, Camille Haudebert, Claire Richard, Juan Penafiel, Lucas Freton, et al. Impact of Robotic Artificial Urinary Sphincter Implantation in Female Patients on Quality of Life and Patient-reported Outcomes. European Urology Focus, 2025, 10.1016/j.euf.2024.12.002. hal-04935164

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Female Urology - Incontinence

# Impact of Robotic Artificial Urinary Sphincter Implantation in Female Patients on Quality of Life and Patient-reported Outcomes

Alexandre Dubois<sup>a,*</sup>, Camille Haudebert<sup>a</sup>, Claire Richard<sup>a</sup>, Juan Penafiel<sup>a</sup>, Lucas Freton<sup>a</sup>, Caroline Voiry<sup>b</sup>, Emmanuelle Samson<sup>b</sup>, Andrea Manunta<sup>a,c</sup>, Juliette Hascoet<sup>a</sup>, Benoit Peyronnet<sup>a</sup>

**Article info**

**Article history:**

Accepted December 16, 2024

Available online 6 January 2025

Associate Editor: Christian Gratzke

**Keywords:**

Artificial urinary sphincter

Female

Stress urinary incontinence

Intrinsic sphincter deficiency

Patient-reported outcomes

Quality of life

Questionnaires

**Abstract**

**Background and objective:** Artificial urinary sphincter (AUS) is commonly used in France in female patients with stress urinary incontinence (SUI) due to intrinsic sphincter deficiency (ISD). However, it has never been assessed using patient-reported outcomes. This study aimed to evaluate the functional outcomes of robotic AUS implantation using validated questionnaires.

**Methods:** The data from female patients who underwent robotic AUS implantation at a single academic center between 2014 and 2023 were collected prospectively. Preoperatively, all patients filled out a Urinary Symptoms Profile (USP) questionnaire, and the International Consultation Incontinence Questionnaire Short Form (ICIQ-SF). These were repeated at 3 mo postoperatively and annually along with a Patient Global Impression of Improvement (PGII) score. Quality of life was assessed using question 5 of the ICIQ-SF.

**Key findings and limitations:** Over the study period, 101 robotic female AUS implantation cases were performed by three surgeons. The median patient age was 66 yr (interquartile range: 53-73), and 86.9% had a history of previous SUI surgery. In our cohort, 12 patients had neurogenic SUI (11.8%). In terms of complications, there were 16 intraoperative (15.8%) and 26 postoperative (25.7%) complications, all of Clavien grade 1 or 2 except seven of Clavien grade 3B (major complication rate: 6.8%). All patient-reported outcomes improved significantly at 3 mo. The USP SUI subscore decreased from 7.3 preoperatively to 0.8 at 3 mo (/9; *p* < 0.0001), the USP overactive bladder subscore decreased from 12.6 to 5.1 (/21; *p* < 0.0001), and the ICIQ-SF decreased from 16.5 to 3.1 (/21; *p* < 0.0001). Quality of life improved, with the ICIQ-QoL decreasing from 8.8 preoperatively to 0.9 at 3 mo (/10; *p* < 0.0001). The 3-mo PGII score was 1/7 (very much improved) in 79 patients (78.8%).

**Conclusions and clinical implications:** Robot-assisted AUS implantation in female patients has low morbidity and improves the patient-reported outcomes and quality of life of female patients with SUI due to ISD.

<footnote><sup>a</sup>Department of Urology, University of Rennes, Rennes, France; <sup>b</sup>Department of Physical Medicine and Rehabilitation, University of Rennes, Rennes, France;</footnote>

<footnote><sup>c</sup>Department of Urology, Clinique Mutualiste La Sagesse, Rennes, France</footnote>

<footnote>* Corresponding author. University Hospital of Rennes, 2 Rue Henri le Guilloux, Rennes 35000, France. Tel. +33 6 13 62 53 19. E-mail addresses: [alexandreduboisint@gmail.com](mailto:alexandreduboisint@gmail.com), [alexandre.dubois@chu-rennes.fr](mailto:alexandreduboisint@gmail.com) (A. Dubois).</footnote>
**Patient summary:** This study represents the largest cohort of robotic female artificial urinary sphincter (AUS) implantation in the literature and is the first to report the patient-reported outcomes (PROMs) after female AUS implantation using validated questionnaires. We found significant improvement in all PROMs at 3 mo, except for voiding dysfunction symptoms. This study brings new robust data to help the widespread use of female AUS across the world, even if further studies with longer follow-up are needed to confirm that these results are maintained over time. We then compared the continence status reported by the patients with PROMs, finding a significant association. This highlights that the existing literature on female AUS, which lacks such PROMs, remains of interest.

© 2024 The Author(s). Published by Elsevier B.V. on behalf of European Association of Urology. This is an open access article under the CC BY license (http://creativecommons.org/licenses/by/4.0/).

# 1. Introduction

Stress urinary incontinence (SUI) is a highly prevalent symptom [1,2]. SUI is physically debilitating and has important professional and social impacts, which alter quality of life [3]. In France, female artificial urinary sphincter (AUS) is commonly used to treat SUI due to intrinsic sphincter deficiency (ISD) [4]. Studies have reported promising functional outcomes even for severe SUI, and the rise of the robotic approach has been associated with significantly decreased morbidity [5,6]. However, the absence of standardized continence definitions and the heterogeneous functional endpoints in the literature (eg, evaluation of complete continence, social continence, and improved continence) are important limitations to the quality of evidence available on female AUS, hampering its possible wider use [7]. The use of patient-reported outcomes (PROMs) has increasingly been praised over the past decades to properly assess therapeutic interventions in a patient-centered fashion. Even though validated questionnaires exist to assess PROMs in female patients with SUI [8], no study has assessed female AUS functional outcomes using these questionnaires. This study aimed to evaluate the functional outcomes of female robotic AUS implantation and its impact on patients' quality of life using validated questionnaires and PROMs.

# 2. Methods

## 2.1. Study design

The data of all female patients who underwent robotic AUS implantation at a single academic center between January 2014 and December 2023 were collected prospectively. The database was analyzed retrospectively for the purpose of the present study. Female AUS was offered as a surgical option to female patients with severe SUI due to ISD, that is, patients with a positive cough stress test and a poorly mobile urethra on physical examination with a low maximum urethral closure pressure on urodynamics. Fascial sling and/or bulking agents (Bulkamid) injections and/or periurethral balloons (Adjustable Continence Therapy) were offered as alternatives to all patients.

According to the existing guidelines, SUI was evaluated preoperatively using clinical interview, physical examination with a cough stress test, free uroflowmetry, ultrasound

post-void residual, urodynamics, and validated questionnaires. All patients filled out a Urinary Symptoms Profile (USP) score, which is divided into three subscores (SUI subscore /9, overactive bladder [OAB] subscore /21, and voiding symptoms subscore /9), and the International Consultation Incontinence Questionnaire Short Form (ICIQ-SF). These were repeated at 3 mo postoperatively in order to assess the functional outcomes of female AUS implantation along with the Patient Global Impression of Improvement (PGII). Quality of life was assessed using question 5 of the ICIQ-SF (ICIQ-SF q5; see the Supplementary material). All patients were asked to fill out these questionnaires in the waiting room, just prior to each visit with the surgeons, on paper forms and on their own, to avoid any possible biases inherent to the participation/help of any health care professional.

The following baseline characteristics were collected in a dedicated computerized dataset for all patients: age at the time of AUS implantation, body mass index, American Society of Anesthesiologists score, etiology of incontinence (neurogenic vs non-neurogenic), history of radiotherapy, history of previous anticontinence surgery, number of pads per day, type of pad, presence of urgency, maximum free urinary flow, and post-void residual. We collected urodynamics parameters such as detrusor overactivity, maximum bladder capacity, and maximum urethral closure pressure. The following perioperative outcomes were recorded: mean operative time, estimated blood loss, cuff size, length of hospital stay, intraoperative complications (eg, vaginal or bladder neck injury), and name of the surgeons. Early postoperative complications were defined as any complications that occurred in the month after the surgery and were graded according to the Clavien-Dindo classification [9].

This study was approved by the Comité National Informatique et Liberté (CNIL 2235713v0) and was conducted following the principles of the Helsinki Declaration.

## 2.2. Surgical technique

The surgical technique used was the anterior approach described previously by Peyronnet et al [10]. Briefly, after a 14 Fr bladder catheter has been inserted, the patient is placed in a 23° Trendelenburg position, five ports are placed according to the usual port placement for Intuitive Da Vinci robotic pelvic surgery, and a transperitoneal access is
created (an extraperitoneal approach was used only in a handful of very selected cases). The Retzius space is dissected, dropping the bladder from the abdominal wall down to the endopelvic fascia on both sides of the bladder neck. The dissection is always guided by the assistant who places a finger in one of the anterior vaginal fornix, and the endopelvic fascia is opened laterally on the tip of the assistant finger and freed sufficiently to enter the vesicovaginal space, which is developed medially behind the posterior aspect of the bladder neck under direct vision. The same step is repeated on the contralateral side until the two created spaces are joined to place a measuring tape around the bladder neck, which is sized properly. The cuff is then inserted through the 12-mm port and placed around the bladder neck. The 61-70 cmH₂O pressure regulating balloon is inserted in the abdomen through a 3-cm subinguinal incision, which is also used to insert the pump in the labia majora and to make the connections. The AUS is deactivated; the bladder catheter is removed in the operating room or on postoperative day 1. The AUS is then activated at 6 wk. All the procedures were performed by three surgeons.

## 2.3. Outcomes of interest

The primary endpoint was the PGII at 3 mo.

The secondary outcomes of interest were the following: (1) change of the USP SUI subscore, ICIQ-SF, and ICIQ-SF q5 at 3 mo; (2) continence status at 3 mo as self-reported by the patient during clinical interview and categorized as follows: complete resolution of SUI (zero pads), improved SUI (one pad a day), or unchanged SUI (more than one pad a day); (3) peri- and postoperative complications; (4) major postoperative complications defined as a Clavien-Dindo grade of ≥3; and (5) Other perioperative outcomes: mean operative time, estimated blood loss, cuff size, and length of hospital stay. Explantation was performed when cuff or pump erosion occurred or in cases of device infection. In these cases, two options were offered to the patients: either placing an autologous sling at the time of explantation, given the significant psychological impact of recurrent SUI, or removing the device with concomitant placement of a fatty flap (Martius flap, omental flap, or peritoneal flap) and waiting 3-6 mo before considering new AUS implantation. Explantation was also offered in rare cases for difficulties in manipulating the pump that remained unsolved despite repeat hospitalizations for patients' education. A revision of the device was performed for mechanical or nonmechanical failure. In rare occasions, it was used to relocate the pump in case of difficulties manipulating it or because of pain in a seated position.

## 2.4. Statistical analysis

Means and standard deviations were reported for continuous variables, medians and ranges for categorical variables, and proportions for nominal variables. Comparisons between groups were performed using the $\chi^2$ test or Fisher's exact test for discrete variables, and the Mann-Whitney U test for continuous variables as appropriate, with a Bonferroni correction for multiple comparisons.

Change of continuous variables over time was assessed using the paired Student t test.

All the functional outcomes were given in an intention-to-treat fashion, that is, the continence status and PROMs of patients who had their AUS explanted or revised were included.

Statistical analyses were performed using JMP version 12.0 software (SAS Institute Inc., Cary, NC, USA). All tests were two sided, with $p < 0.05$ as a threshold to define statistical significance.

# 3. Results

## 3.1. Patients' characteristics

Over the study period, 101 cases of robotic female AUS implantation were performed and included in the present analysis (Table 1). The median patients' age was 66 yr (interquartile range: 21-85) and the mean body mass index was 27.8 (±5.3). Most of the patients had a history of previous SUI surgery (91.1%) with 70.3% of previous midurethral sling surgery. Only two of them had a history of pelvic radiotherapy, and 12 patients had neurogenic SUI (11.9%). Regarding urodynamic parameters, the mean maximum urethral cloture pressure was 29.3 (±13.9) cmH₂O, the mean maximum cystometric capacity was 429.8 (±116.7) ml, and 21 patients had prior detrusor overactivity. The median number of pads per day was 3 (1-15).

## 3.2. Perioperative outcomes

The perioperative outcomes are presented in Table 2. The mean operative time was 156.8 (±50.2) min, with a mean estimated blood loss of 89.1 (±114.1) ml. The median AUS cuff size was 75 mm ranging from 50 to 90 mm, and the median length of hospital stay was 2 (0-7) d. There were 18 cases of intraoperative complications (17.8%): eight of bladder injury, nine of vaginal injury, and one of bowel injury. The most frequent complication was acute urinary retention (4%). Among the 27 postoperative complications, nine were of Clavien-Dindo grade 3: two urethrovaginal

<table><caption>Table 1 - Patients' characteristics</caption><thead><tr><th>Number of patients</th><th>101</th></tr></thead><tbody><tr><td>Median age (yr)</td><td>66 (21-85)</td></tr><tr><td>ASA score, n (%)</td><td></td></tr><tr><td>1</td><td>27 (26.7)</td></tr><tr><td>2</td><td>65 (64.3)</td></tr><tr><td>3</td><td>9 (8.9)</td></tr><tr><td>Anticoagulant or antiplatelet intake, n (%)</td><td>15 (14.7)</td></tr><tr><td>Mean body mass index (kg/m²)</td><td>27.8 (±5.3)</td></tr><tr><td>History of previous pelvic radiotherapy, n (%)</td><td>2 (2)</td></tr><tr><td>History of previous anti-incontinence surgery, n (%)</td><td>92 (91.1)</td></tr><tr><td>History of previous midurethral slings surgery, n (%)</td><td>71 (70.3)</td></tr><tr><td>Median number of midurethral sling</td><td>1 (0-4)</td></tr><tr><td>Mean maximum urethral cloture pressure (cmH₂O)</td><td>29.3 (±13.9)</td></tr><tr><td>Detrusor overactivity, n (%)</td><td>21 (21.2)<br>Missing data (N = 2)</td></tr><tr><td>Mean maximum cystometric capacity (ml)</td><td>429.8 (±116.7)</td></tr><tr><td>Median number of pads per day</td><td>3 (1-15)</td></tr><tr><td>Neurogenic stress urinary incontinence, n (%)</td><td>12 (11.9)</td></tr><tr><td colspan="2">ASA = American Society of Anesthesiologists.</td></tr></tbody></table>
<table><caption>Table 2 – Perioperative outcomes</caption><thead><tr><th></th><th>Female AUS<br>(N = 101)</th></tr></thead><tbody><tr><td>Mean operative time (min)</td><td>156.8 (±50.2)</td></tr><tr><td>Median AUS cuff size (mm)</td><td>75 (range: 50-90)</td></tr><tr><td>Mean estimated blood loss (ml)</td><td>89.1 (±114.1)</td></tr><tr><td>Intraoperative complications, n (%)</td><td>18 (17.8)</td></tr><tr><td>Bladder injury</td><td>8 (7.9)</td></tr><tr><td>Vaginal injury</td><td>9 (8.9)</td></tr><tr><td>Bowel injury</td><td>1 (1)</td></tr><tr><td>Postoperative complications</td><td>27 (26.7)</td></tr><tr><td>Major postoperative complications, n (%)</td><td>9 (9)</td></tr><tr><td>Grade 3a</td><td>1 (1)</td></tr><tr><td>Grade 3b</td><td>8 (8)</td></tr><tr><td>Grade 4 or 5</td><td>0 (0)</td></tr><tr><td>Median length of hospital stay (d)</td><td>2 (0-7)</td></tr><tr><td colspan="2">AUS = artificial urinary sphincter.</td></tr></tbody></table>

fistulas, one pump replacement, one pump erosion through labia majora and three vaginal exposure, one suspected device infection requiring exploratory laparoscopy, and one abdominal wall abscess. With the exception of the last two complications described, these all result in device removal.

### 3.3. Functional outcomes

All PROMs were significantly improved at 3 mo except the USP voiding dysfunction subscore, which remain stable (1.8 vs 1.3; *p* = 0.26; Table 3). Seven patients were missing the 3-mo data, and 11 patients were missing the 12-mo data. The USP SUI subscore decreased from 7.3 preoperatively to 0.8 at 3 mo (/9; *p* < 0.001), 1.7 at 6 mo (*p* < 0.001), and 1.1 at 1 yr (*p* < 0.001; Fig. 1). The USP OAB subscore decreased from 12.6 to 5.1 at 3 mo (/21; *p* < 0.001), 6 at 6 mo (*p* < 0.001), and 4.1 at 1 yr (*p* < 0.001). The ICIQ-SF decreased from 16.5 preoperatively to 3.1 at 3 mo (/21; *p* < 0.001) 4.1 at 6 mo (*p* < 0.001), and

3.2 at 1 yr (*p* < 0.001). The quality of life improved, with the ICIQ-QoL decreasing from 8.7 preoperatively to 0.9 at 3 mo, 6 mo, and 1 yr (/10; *p* < 0.001). The median number of pads used per day decreased from 4 to 0 at 3 mo (*p* < 0.001). The 3-mo PGII was 1/7 (very much improved) in 73 patients (72.8%), 2/7 (much improved) in 11 patients (11%), 3/7 (slightly improved) in six patients (6%), and 4/7 (unchanged) in nine patients (9%), and worsened (from 5 to 7) in two patients (2%). The 1-yr PGII was very much improved in 72.54%, much improved in 7.85%, slightly improved in 9.8%, unchanged in 5.88%, and worsened in 1.9%.

At 3 mo, 68 patients achieved complete continence (67.3%), 22 had improved continence (21.9%), and 11 had unchanged or worsened continence (10.9%). After a median follow-up of 18 mo, the continence at the last follow-up was complete in 68 patients (67.3%), improved in 11 patients (10.9%), and unchanged or worsened in 22 patients (21.8%). Two of the patients were continent despite the fact that the AUS was deactivated.

### 3.4. Device outcomes

There were nine revisions (8.9%) and ten explantations (9.9%) over the study period. The causes of revision were bladder neck atrophy/cuff downsizing (N = 3), mechanical failure (N = 5), and pump transposition (N = 2). The causes of explantation were vaginal exposure (N = 5), urethral extrusion (N = 3), and labial exposure of the pump (N = 2). Five devices were never activated because the patients were not able to manipulate the pump (4.9%). The median time to explantation was 13 (range: 0-42) mo. The median time to revision was 15 (range: 2-74) mo.

### 3.5. PROMs versus self-reported continence status

There were statistically significant associations between the self-reported continence status and the USP SUI subscore (*p* = 0.01), ICIQ-SF (*p* = 0.04), and ICIQ-SF-QoL (*p* = 0.02). The PGII was also significantly associated with the self-reported continence status (*p* < 0.001; Table 4). The PGII was significantly associated with the USP SUI subscore (*p* < 0.001), USP OAB subscore (*p* = 0.04), ICIQ-SF (*p* = 0.002), and ICIQ-SF-QoL (*p* < 0.001).

<table><caption>Table 3 – Changes of patient-reported outcomes over time</caption><thead><tr><th>N = 101</th><th>Preoperatively</th><th>3 mo postoperatively</th><th>p value</th></tr></thead><tbody><tr><td>Median number of pads/ 24 h</td><td>4 (range: 1-20)</td><td>0 (range: 0-4)</td><td>&lt;0.001</td></tr><tr><td>Mean ICIQ-SF (/21)</td><td>16.5 (±3.8)</td><td>3.1 (±5.8)</td><td>&lt;0.001</td></tr><tr><td>Mean ICIQ-SF-QoL (/10)</td><td>8.7 (±1.9)</td><td>0.9 (±3.5)</td><td>&lt;0.001</td></tr><tr><td>Mean USP SUI subscore (/ 9)</td><td>7.3 (±2.4)</td><td>0.8 (±1.7)</td><td>&lt;0.001</td></tr><tr><td>Mean USP OAB subscore (/9)</td><td>12.6 (±3.9)</td><td>5.1 (±5.1)</td><td>&lt;0.001</td></tr><tr><td>Mean USP voiding symptoms subscore (/ 9)</td><td>1.8 (±2.8)</td><td>1.4 (±2.7)</td><td>0.26</td></tr><tr><td>Continence status, n (%)</td><td></td><td></td><td></td></tr><tr><td>Complete continence</td><td></td><td>68 (67.3)</td><td></td></tr><tr><td>Improved continence</td><td>NA</td><td>22 (21.8)</td><td>NA</td></tr><tr><td>Unchanged continence</td><td></td><td>11 (10.9)</td><td></td></tr><tr><td>PGII, n (%)</td><td></td><td></td><td></td></tr><tr><td>1: very much improved</td><td></td><td>73 (72.8)</td><td></td></tr><tr><td>2: much improved</td><td>NA</td><td>11 (11)</td><td>NA</td></tr><tr><td>3: improved</td><td></td><td>6 (6)</td><td></td></tr><tr><td>4: unchanged</td><td></td><td>9 (9)</td><td></td></tr><tr><td>5-7: worsened</td><td></td><td>2 (2)</td><td></td></tr><tr><td colspan="4">ICIQ-SF = International Consultation Incontinence Questionnaire Short Form; NA = not applicable; OAB = overactive bladder; PGII = Patient Global Impression of Improvement; QoL = quality of life; SUI = stress urinary incontinence; USP = Urinary Symptoms Profile.</td></tr></tbody></table>

## 4. Discussion

Since the first female AUS implantation, excellent continence results have been reported. Although scientific societies such as the European Association of Urology and the International Continence Society (ICS) recommend using questionnaires and quality of life assessments in clinical trials, our study is the first to report the PROMs after female AUS implantation using validated questionnaires [11]. This focus on patient-reported symptoms and quality of life stems from the heterogeneous and imprecise definition of continence. Similar to other SUI treatments, we believe that assessment of female AUS efficacy based solely on the continence status as self-reported by the patients is insufficient [12].
<figure><img src="image_2.png" /><figcaption>Fig. 1 – Change in USP ICIQ-SF scores and subscores over the 1st year. ICIQ-SF = International Consultation on Continence Questionnaire Short Form; ICIQ-QoL = International Consultation on Continence Questionnaire Quality of Life; ICIQ-SF = International Consultation on Continence Questionnaire Short Form; OAB = overactive bladder; SUI = stress urinary incontinence; USP = Urinary Symptom Profile score.</figcaption></figure>

<table><caption>Table 4 – PROMs versus self-reported continence status at 3 mo</caption><thead><tr><th></th><th>Complete continence<br>(N = 68)</th><th>Improved continence<br>(N = 22)</th><th>Unchanged/worsened continence<br>(N = 11)</th><th>p value</th></tr></thead><tbody><tr><td>Median number of pads/24 h</td><td>0 (range: 0-0)</td><td>1 (range: 0-3)</td><td>2 (range: 0-4)</td><td>&lt;0.001</td></tr><tr><td>Mean ICIQ-SF (/21)</td><td>2.4 (±4.7)</td><td>5.5 (±7.4)</td><td>9 (±8.3)</td><td>0.04</td></tr><tr><td>Mean ICIQ-SF-QoL (/10)</td><td>1.3 (±3.5)</td><td>2.2 (±3.3)</td><td>6.3 (±5.5)</td><td>0.02</td></tr><tr><td>Mean USP SUI subscore (/9)</td><td>0.5 (±1.6)</td><td>0.8 (±1.1)</td><td>2.8 (±2.8)</td><td>0.01</td></tr><tr><td>Mean USP OAB subscore (/9)</td><td>4.4 (±5)</td><td>6.1 (±5)</td><td>8.6 (±2.2)</td><td>0.14</td></tr><tr><td>PGII, n (%)</td><td></td><td></td><td></td><td></td></tr><tr><td>1: very much improved</td><td>54 (85.7)</td><td>11 (57.9)</td><td>1 (11.1)</td><td></td></tr><tr><td>2: much improved</td><td>4 (6.4)</td><td>4 (21.1)</td><td>1 (11.1)</td><td>&lt;0.001</td></tr><tr><td>3: improved</td><td>4 (6.4)</td><td>1 (5.3)</td><td>1 (11.1)</td><td></td></tr><tr><td>4-7: unchanged/worsened</td><td>1 (1.6)</td><td>3 (15.8)</td><td>6 (66.7)</td><td></td></tr></tbody><tfoot><tr><td colspan="5">ICIQ-SF = International Consultation Incontinence Questionnaire Short Form; OAB = overactive bladder; PGII = Patient Global Impression of Improvement; QoL = quality of life; SUI = stress urinary incontinence; USP = Urinary Symptoms Profile.</td></tr></tfoot></table>

We found significant improvement in all PROMs at 3 mo, except for the USP voiding dysfunction subscore. The majority of patients rated their postoperative condition as “very much better” on the PGII score. These findings align with the high continence rates in our population and the significant improvement in incontinence-related quality of life. However, these excellent outcomes must be considered alongside the complications observed, ranging from minor issues such as acute urinary retention and urinary tract infections to more severe problems such as erosion or device infection, which sometimes necessitated device removal. This risk-benefit ratio could be interpreted differently by clinicians and may in part explain the heterogeneity that remains across the world in the use of female AUS [13].

There is no standardization in the use of questionnaires for evaluating SUI [14]. We selected three different questionnaires: the ICIQ-SF, the USP score, and the PGII score. These

tools are approved by the ICS and are quick and easy to use in daily practice, ensuring sustained patient compliance [8].

The USP score is practical for all types of patients, efficiently capturing a wide range of urinary symptoms and quantifying their severity [15]. Additionally, the voiding dysfunction subscore helps screen for potential complications. However, its sensitivity to change has been evaluated only in the treatment of benign prostate hyperplasia, and we have no data available for SUI, which is a limitation [16]. The ICIQ-SF is more specific to SUI and is spread widely among researchers in the field.

There is no consensus on the best instruments to evaluate the impact of SUI on quality of life, so we opted to assess this parameter using the fifth question of the ICIQ-SF questionnaire. However, relying on a single general question limits our ability to evaluate the impact in detail. Based on a systematic review by Wuytack et al [17], further
evaluations could use the Incontinence Quality of Life (I-QOL) questionnaire, as it appears to be the most robust tool for disease-specific evaluation. However, it is also important, for a more comprehensive assessment, to pair the I-QOL questionnaire with a generic quality of life questionnaire.

The PGII, validated for urinary incontinence assessment and many other conditions, measures satisfaction or dissatisfaction after treatment compared with a baseline state [18]. Its strength lies in being patient centered, revealing the impact on the most significant aspects of patients' life and their treatment expectations. However, it does not provide details on the baseline state or satisfaction before the intervention, making it less suitable for long-term follow-up, as the baseline state may change with additional treatments.

Interestingly, the USP OAB subscore was also improved postoperatively. Several hypotheses could be made to explain this finding. First, the OAB subscore may lack specificity in patients with severe urinary incontinence, as the score tends to decrease when continence improves after implantation. Another assumption is that the removal of all the materials from previous anti-incontinence procedures during device implantation (eg, midurethral slings, Burch colposuspension stitches, and pubovaginal sling) relieves bladder outlet obstruction and may inherently result in OAB improvement. Urinary frequency could become behavioral ("by caution") in patients with severe SUI, which may also resolve after recovering continence. Finally, OAB symptoms may be related to a urethrovesical reflex (urethrogenic urgency), which may be corrected following device implantation [19].

There are several explanations for the lack of perceived improvement after device implantation. First, some patients may have preoperative mixed incontinence and urgency incontinence that persists after AUS implantation. OAB can be present either preoperatively (due to radiotherapy or chronic obstruction after previous anti-incontinence surgery) or postoperatively as de novo OAB has been described [20]. Another potential explanation could be the early mechanical failure (eg, if air had been introduced into the system during the procedure). Finally, some failure and complications can be explained by difficulties in manipulating the pump.

We found a statistically significant association between self-reported continence (ie, the number of pads used per 24 h, as reported by the patient during a clinical interview) and PROMs. This suggests that the existing literature that lacks PROMs is still of interest. However, self-reported continence status did not match perfectly with PROMs and especially the PGII, which underlines the fact that objective evaluation of continence as self-reported by the patients for AUS implantation is insufficient to evaluate its functional outcomes properly, as shown in suspension procedures [12]. We may advise that future studies should take into account subjective parameters such as PROMs and quality of life while investigating the results of female AUS implantation.

This study represents the largest cohort of robotic female AUS implantation in the literature; however, it has several limitations that should be considered when interpreting

our findings. First, the retrospective nature of the study introduces potential biases, although prospective completion of the questionnaires minimizes errors, with only minimal missing data. The study was conducted in a tertiary center, which may handle more complex cases than lower-volume institutions. Additionally, quality of life was assessed using only a general question, whereas some have recommended using at least one incontinence-specific questionnaire and one generic health-related questionnaire [21]. Regarding continence evaluation, the 24 h pad test has been validated for AUS assessment [22]. However, we were unable to use these data due to the low compliance of the patients in our cohort. Using only the number of pads per day may represent another limitation of our study. Owing to a limited number of patients with detrusor underactivity (DU) or neurogenic SUI, we could not perform a proper subgroup analysis. This could be regarded as a shortcoming of the present study, and future analyses gathering larger cohort of DU or neurogenic SUI patients with female AUS are needed. Our functional outcomes may look slightly less favorable than those of previous series [6]. The prospective nature of data collection and the limited number of patients lost to follow-up along with the intention-to-treat analysis may explain this finding. We believe that this is a point of strength of our study as it gives more realistic data to present to the patients preoperatively to set realistic goals and expectations. We focused on the functional outcomes of robotic female AUS, which we decided to stress in the title. However, the impact of the surgical approach on female AUS functional outcomes remains uncertain, and our decision could therefore be debated.

Finally, the results presented cover a short postoperative period and longer-term data would be valuable to confirm these findings, especially considering the potential for late erosion and de novo bladder overactivity. Collecting PROMs using validated questionnaires becomes increasingly difficult over time due to declining patient compliance, and we can hope for a future prospective study that will provide more robust PROM data for female AUS.

## 5. Conclusions

Robot-assisted AUS implantation in female patients improves the PROMs and quality of life of female patients with SUI due to ISD, although longer follow-up data are needed to confirm that these results are maintained over time. These functional outcomes should be weighed against the risk of mechanical and technical failures, which should be presented clearly to the patients preoperatively. The continence status as reported subjectively by the patients is significantly associated with the PROMs, which suggests that the existing literature on female AUS, which lack such PROMs, is still of interest. Future studies investigating the results of female AUS implantation should evaluate its effectiveness using PROMs and quality of life evaluation.

**Author contributions:** Alexandre Dubois had full access to all the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis.
**Study concept and design:** Dubois, Peyronnet.

**Acquisition of data:** All authors.

**Analysis and interpretation of data:** Dubois, Peyronnet.

**Drafting of the manuscript:** Dubois, Peyronnet.

**Critical revision of the manuscript for important intellectual content:**
Peyronnet.

**Statistical analysis:** Peyronnet.

**Obtaining funding:** None.

**Administrative, technical, or material support:** None.

**Supervision:** Dubois, Peyronnet.

**Other:** All authors have reviewed the manuscript.

**Financial disclosures:** Alexandre Dubois certifies 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: Benoit Peyronnet is a consultant for Boston Scientific, Intuitive, Medtronic, Pierre Fabre, Ibsa, Coloplast, Schwa medico, Hollister, Ipsen, and AbbVie. The other authors have no disclosure.

**Funding/Support and role of the sponsor:** None.

## Appendix A. Supplementary data

Supplementary data to this article can be found online at
https://doi.org/10.1016/j.euf.2024.12.002.

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