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Telemedicine follow-up is safe and efficacious for synthetic midurethral slings: a randomized, multi-institutional control trial

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Abstract

Introduction and hypothesis

The objective was to assess whether telemedicine-based follow-up is equivalent to office-based follow-up in the early postoperative period after routine synthetic midurethral sling placement.

Methods

This is a prospective, international, multi-institutional, randomized controlled trial. Patients undergoing synthetic midurethral sling placement were randomized to 3-week postoperative telemedicine versus office-based follow-up. The primary outcome was the rate of unplanned events. Secondary outcomes included patient satisfaction, crossover from telemedicine to office-based follow-up, and compliance with 3- to 5-month office follow-up.

Results

We included 238 patients (telemedicine: 121 vs office: 117). No differences in demographics or medical comorbidities were noted between the study groups (p = 0.09–1.0). No differences were noted in unplanned events: hospital admission, emergency department visit, or unplanned office visit or call (14% vs 12.9%, p = 0.85) or complications (9.9% vs 8.6%, p = 0.82). Both groups were equally “very satisfied” with their surgical outcomes (71.1% vs 69%, p = 0.2). Telemedicine patients were more compliant with 3- to 5-month office follow-up (90.1% vs 79.3%, p = 0.04).

Conclusions

After synthetic midurethral sling placement, telemedicine follow-up is a safe patient communication option in the early postoperative period. Telemedicine patients reported no difference in satisfaction compared with office-based follow-up but had greater compliance with 3- to 5-month follow-up.

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Acknowledgements

Courtenay Moore MD, Cleveland Clinic, Cleveland, OH, USA (surgeon); Raymond Rackley MD, Cleveland Clinic, Cleveland, OH, USA (surgeon); Sandip Vasavada MD, Cleveland Clinic, Cleveland, OH, USA (surgeon); Kathleen Scott PA, Cleveland Clinic, Cleveland, OH, USA (patient recruitment and follow-up); Elizabeth Stark PA, Cleveland Clinic, Cleveland, OH, USA (patient recruitment and follow-up); Elodi Dielubanza MD, Cleveland Clinic, Cleveland, OH, USA (protocol development); Xu Lei PA, Renji Hospital, Shanghai, China (patient recruitment and follow-up); Fang Weilin MD, Renji Hospital, Shanghai, China (surgeon).

Author information

Authors and Affiliations

  1. Glickman Urological and Kidney Institute, Cleveland Clinic, Cleveland, OH, USA

    Laura L. Giusto, Samir Derisavifard, Patricia M. Zahner, Jessica J. Rueb & Howard B. Goldman

  2. West China Hospital of Sichuan University, Chengdu, China

    Luo Deyi

  3. Department of Urology, Renji Hospital, School of Medicine, Shanghai Jiaotong University, Shanghai, China

    Li Jiayi & Fang Weilin

  4. Hospital Maternidade Escola Vila Nova Cachoerinha, Sao Paulo, Brazil

    Raphael de Jesus Moreira

  5. Louisiana State University Health Shreveport, Shreveport, LA, USA

    Alexander Gomelsky

  6. Azienda Ospedaliera Universitaria Integrata di Verona, Verona, Italy

    Matteo Balzarro

Authors
  1. Laura L. Giusto
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  2. Samir Derisavifard
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  3. Patricia M. Zahner
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  4. Jessica J. Rueb
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  5. Luo Deyi
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  6. Li Jiayi
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  7. Fang Weilin
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  8. Raphael de Jesus Moreira
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  9. Alexander Gomelsky
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  10. Matteo Balzarro
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  11. Howard B. Goldman
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Contributions

L.L. Giusto: project development, data collection, data analysis, manuscript writing; S. Derisavifard: project development, data collection, data analysis, manuscript writing; P.M. Zahner: project development, data collection, data analysis, manuscript writing; J.J. Rueb: project development, data collection, data analysis, manuscript writing; L. Deyi: project development, data collection; L. Jiayi: project development, data collection; R. Moreira: project development, data collection; A. Gomelsky: project development, data collection; M. Balzarro: project development, data collection; H.B. Goldman: project development, data collection, data analysis, manuscript writing.

Corresponding author

Correspondence to Patricia M. Zahner.

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Conflicts of interest

Laura L. Giusto, Samir Derisavifard, Patricia M. Zahner, Jessica J. Rueb, Luo Deyi, Li Jiayi, Fang Weilin, Raphael de Jesus Moreira, Alexander Gomelsky, Matteo Balzarro: NONE. Howard B. Goldman: Allergan, Medtronic, Laborie, Sacramed, Bluewind, Astellas, Boston Scientific, Bioness, Cook Myosite.

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Appendices

Appendix 1

(2–6 weeks postoperatively) Phone or telemedicine follow–up provider data sheet

Date of surgery:

Date of call/telemedicine visit:

Visit type: telemedicine or phone call

Sling type (i.e., transobturator, retropubic):

Sling trade name:

Primary sling or revision?

Diagnosis: 1) stress urinary incontinence; 2) stress-predominant mixed urinary incontinence; 3) recurrent stress urinary incontinence.

Review of systems

(Circle all that apply)

  1. 1.

    General: fever/malaise/weight loss/other

Details:

  1. 2.

    Cardiovascular: chest pain/shortness of breath/palpitations/edema

Details:

  1. 3.

    Respiratory: chronic cough/wheezing/shortness of breath/other

Details:

  1. 4.

    Neurological: numbness/tingling/pain/other

Details:

  1. 5.

    Gastrointestinal: constipation/diarrhea/fecal incontinence

Details:

Symptoms

  1. 1.

    Stress urinary incontinence: 1) none; 2) minimal; 3) mild; 4) significant, but improved; 5) no improvement; 6) worse

  1. 2.

    Urgency incontinence: 1) none; 2) minimal; 3) mild; 4) significant, but improved; 5) no improvement; 6) worse

  1. 3.

    Urgency: 1) none; 2) minimal; 3) mild; 4) significant, but improved; 5) no improvement; 6) worse

  1. 4.

    Frequency: 1) normal; 2) improved; 3) no change every ___ hours

  1. 5.

    Nocturia: 1) normal; 2) improved; 3) no change; #voids/night:

  1. 6.

    Force of stream: 1) the same; 2) better; 3) a little slower; 4) a lot slower. Strength of stream compared to preoperatively?________%

  1. 7.

    Straining or pushing to void? Yes/no

  1. 8.

    Incomplete emptying? Yes/no

  1. 9.

    UTI before surgery? Yes/no; # in the last 12 months:

  1. 10.

    UTI postoperatively? Yes/no; # since surgery:

Sexual activity

  1. 1.

    Sexually active before surgery? Yes/no

Abstinence reason: 1) relationship status; 2) incontinence; 3) discomfort/pain; 4) partner dysfunction/issues

  1. 2.

    Sexually active after surgery? Active/not active

If active:

Pain with intercourse? Yes/no

Better or worse or same compared with preoperatively?

Partner reports pain/scratching? Yes/no

Patient questions or concerns? (Specify)

Provider notes:

  1. 1.

    Additional testing, medication change, or refill given? Yes/no If yes, specify:

  1. 2.

    Patient or provider requests office-based follow-up? Yes/no

If yes, please provide reason:

Appendix 2

3–5 months universal office follow-up provider data collection form

Date of surgery:

Date of visit:

Surgeon:

Sling type (i.e., transobturator, retropubic):

Sling trade name:

Primary sling or revision?

Diagnosis: 1) stress urinary incontinence; 2) stress-predominant mixed urinary incontinence; 3) recurrent stress urinary incontinence

Review of systems

(Circle all that apply)

  1. 6.

    General: fever/malaise/weight loss/other

Details:

  1. 7.

    Cardiovascular: chest pain/shortness of breath/palpitations/edema

Details:

  1. 8.

    Respiratory: chronic cough/wheezing/shortness of breath/other

Details:

  1. 9.

    Neurological: numbness/tingling/pain/other

Details:

  1. 10.

    Gastrointestinal: constipation/diarrhea/fecal incontinence

Details:

Symptoms

  1. 11.

    Stress urinary incontinence: 1) none; 2) minimal; 3) mild; 4) significant, but improved; 5) no improvement; 6) worse

  1. 12.

    Urgency incontinence: 1) none; 2) minimal; 3) mild; 4) significant, but improved; 5) no improvement; 6) worse

  1. 13.

    Urgency: 1) none; 2) minimal; 3) mild; 4) significant, but improved; 5) no improvement; 6) worse

  1. 14.

    Frequency: 1) normal; 2) improved; 3) no change; every ___ hours

  1. 15.

    Nocturia: 1) normal; 2) improved; 3) no change; #voids/night:

  1. 16.

    Force of stream: 1) the same; 2) better; 3) a little slower; 4) a lot slower. Strength of stream compared with preoperatively? ___%

  1. 17.

    Straining or pushing to void? Yes/No

  1. 18.

    Incomplete emptying? Yes/No

  1. 19.

    UTI before surgery? Yes/No. # in the last 12 months:

  1. 20.

    UTI postoperatively? Yes/No. # since surgery:

Sexual activity

  1. 1.

    Sexually active before surgery? Yes/No

Abstinence reason: 1) relationship status; 2) incontinence; 3) discomfort/pain; 4) partner dysfunction/issues

  1. 2.

    Sexually active after surgery? Active/not active

If active:

Pain with intercourse? Yes/ No

Better or worse or same compared with preoperatively?

Partner reports pain/scratching? Yes/No

Physical examination

Vital signs: BP__________ | Pulse _______ | Temperature _______ | Height_______ |Weight ________ | BMI _______.

General appearance:

Abdomen: soft/nontender/nondistended

Specify if abnormalities:

Neuro/psych: no signs of depression, anxiety, or agitation

Specify if abnormalities:

Extremities: no deformities, edema, clubbing or skin discoloration

Specify if abnormalities:

External genitalia: normal hair distribution, no lesions

Specify if abnormalities:

Vaginal wall: 1) well-healed; 2) healing

1) Mesh palpable; 2) mesh nonpalpable

1) Tender; 2) nontender

Comments:

Incisions: 1) prepubic; 2) inner thigh

1) Well-healed; 2) healing

1) Tender; 2) nontender

Comments:

Mesh extrusion: Yes/No

Comments:

Urethral tenderness: Yes/No

Testing:

Urinalysis:

Postvoid residual:___ mL

figure a

How satisfied are you with the follow-up you received postoperatively?

1) Very satisfied; 2) satisfied; 3) neutral; 4) unsatisfied; 5) very unsatisfied

Patient questions or concerns?

(Specify)

Provider notes:

  1. 3.

    Additional testing, medication changes, or refills given? Yes/No; If yes, specify:

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Giusto, L.L., Derisavifard, S., Zahner, P.M. et al. Telemedicine follow-up is safe and efficacious for synthetic midurethral slings: a randomized, multi-institutional control trial. Int Urogynecol J 33, 1007–1015 (2022). https://doi.org/10.1007/s00192-021-04767-1

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